{"url_path":"/sec/cupr/10-k/2026/item-4","section_key":"item-4","section_title":"Item 4 INFORMATION ON THE COMPANY**","topic":"sec","document":{"doc_type":"20-F","doc_date":"2026-04-27","source_url":"https://www.sec.gov/Archives/edgar/data/1995704/0001493152-26-019085-index.html","accession_number":"0001493152-26-019085","cik":"0001995704","ticker":"CUPR","issuer_name":"Cuprina Holdings (Cayman) LTD","edgar_url":"https://www.sec.gov/Archives/edgar/data/1995704/0001493152-26-019085-index.html","primary_entity_key":"0001995704","primary_entity_name":"Cuprina Holdings (Cayman) LTD"},"word_count":38927,"has_tables":true,"body_markdown":"**ITEM\n4. INFORMATION ON THE COMPANY**\n\n \n\n**A.\nHistory and Development of the Company.**\n\n \n\nPrior\nto the incorporation of the Company, the principal operations are carried out through Cuprina Pte. Ltd. in Singapore, which was founded\nby Mr. Baptista Carl Marc, our previous CTO. We have conducted a reorganization, primarily to facilitate our initial public offering\nin the United States, which was completed in January 2024.\n\n \n\nThe\nownership of our subsidiaries are as follows:  \n\n \n\n**Name**\n \n**Background**\n \n**Ownership**\n\nCuprina\nHoldings (BVI) Limited\n \nIncorporated\non October 3, 2023 under the laws of the BVI as a holding company.\n \n100%\nowned by Cuprina Cayman\n\nCuprina\nPte. Ltd.\n \nIncorporated\non August 28, 2019 as a private company limited by shares under the laws of Singapore and owned by Cuprina Holding Pte. Ltd prior\nto the reorganization.\n \n100%\nowned by Cuprina Holdings (BVI) Limited\n\nCuprina\nUnited\n\nStates\nInc.\n\n \n\n \nIncorporated\non April 6, 2022 as a private company limited by shares under the laws of the U.S.\n \n100%\nowned by Cuprina Pte. Ltd.\n\nCuprina\nMalaysia Sdn. Bhd.\n \nIncorporated\non March 29, 2022 as a private company limited by shares under the laws of the Malaysia.\n \n100%\nowned by Cuprina Pte. Ltd.\n\nCuprina\n(Beijing) Biotechnology Co. Ltd.\n \nIncorporated\non July 26, 2022 as a private company limited by shares under the laws of the PRC.\n \n100%\nowned by Cuprina Pte. Ltd.\n\nCuprina\nHong Kong Limited\n \nIncorporated\non May 17, 2022 as a private company limited by shares under the laws of Hong Kong.\n \n100%\nowned by Cuprina Pte. Ltd.\n\n \n\nCuprina\nCayman was incorporated as an exempted company in the Cayman Islands on September 22, 2023.\n\n \n\n**Completion\nof the Initial Public Offering**\n\n \n\nOn\nApril 11, 2025, we closed our IPO of 3,000,000 Class A Ordinary Shares at a public offering price of US$4.00 per share. The total net\nproceeds to the Company from the IPO, after deducting discounts, expenses allowance and expenses, were approximately US$9,184,726. On\nMay 8, 2025, we closed the Over-Allotment Option of our IPO of 450,000 Class A Ordinary Shares at a price of US$4.00 per share, pursuant\nto the full exercise of the Over-Allotment Option, resulting in additional gross proceeds of approximately US$1,800,000. As a result,\nwe raised aggregate net proceeds of US$10,849,726 in the IPO, including the exercise of the Over-Allotment Option, after deducting discounts,\nexpenses allowance and expenses. The Class A Ordinary Shares were previously approved for listing on Nasdaq Capital Market and commenced\ntrading under the ticker symbol “CUPR” on April 10, 2025.\n\n \n\n29\n\n \n\n \n\n**Our\nCorporate Structure**\n\n \n\nWe\nare a Cayman Islands business company incorporated on September 22, 2023, as a holding company of our business, which is primarily operated\nthrough our indirect wholly-owned Singapore subsidiary, Cuprina Pte. Ltd..\n\n \n\nThe\nfollowing chart illustrates our corporate structure as of the date of this Annual Report:\n\n \n\n \n\nFor\ndetails of our principal shareholders’ ownership, please refer to the beneficial ownership table in “Item 6. Directors, Senior\nManagement and Employees—E. Share Ownership.”\n\n \n\n**Corporate\nInformation**\n\n \n\nOur\nprincipal office is located at Blk 1090 Lower Delta Road #06-08 Singapore 169201and our telephone number is +65 8512 7275. Our registered\noffice in the Cayman Islands is located at the office of Harneys Fiduciary (Cayman) Limited, 4th Floor, Harbour Place, 103 South Church\nStreet, P.O. Box 10240, Grand Cayman KY1-1002, Cayman Islands. Our agent for service of process in the United States is Cogency Global\nInc., 122 East 42nd Street, 18th Floor, New York, NY 10168. We maintain a website at https://www.cuprina.com. We do not incorporate the\ninformation on our website into this Report and the information contained therein or connected thereto shall not be deemed to be part\nof this Report.\n\n \n\n**B.\nBusiness overview**\n\n \n\n**Overview**\n\n \n\nWe\nare a Singapore-based biomedical and biotechnology company that is dedicated to the development and commercialization of innovative products\nfor the management of chronic wounds, as well as operating in the health and beauty sector. Our expertise in biomedical research allows\nus to identify and utilize materials derived from natural sources to develop wound care products in the form of medical devices which\nmeet international standards. We believe we will be able to build upon and leverage such expertise to develop innovative cosmeceutical\nproducts in the future.\n\n \n\nAs\nof December 31, 2025, we manufactured and distributed a line of medical grade sterile blowfly larvae bio-dressing products marketed under\nthe MEDIFLY brand name, or the MEDIFLY products. The MEDIFLY products are used as a biological debridement tool for chronic wounds, in\na procedure known as Maggot Debridement Therapy, or MDT, which is an effective alternative to surgical debridement. In addition to our\ncurrently commercialized MEDIFLY products, we have three lines of chronic wound care products in our pipeline. Such lines of pipeline\nchronic wound care products include:\n\n \n\n \n●\nCollagen\ndressings, including sponges, particles and hydrogels utilizing bullfrog collagen derived from the valorization of abattoir waste\nstreams of American bullfrogs (*Lithobates catesbeianus*);\n\n \n \n \n\n \n●\nIodine-based\ntopical antiseptic products for wound care; and\n\n \n \n \n\n \n●\nProducts\nutilizing medical leeches for wound treatment.\n\n \n\nWe\ncurrently expect development of such products to take place over the course of 2026 and 2027 and to become commercially available subject\nto regulatory approval.\n\n \n\nWe\nbelieve what sets us apart is our focus on developing functionally specific chronic wound care products designed to address the major\nstages of wound healing process, from chronic to closure.\n\n \n\nOur\nchronic wound care products, including both our existing commercialized products and forthcoming products in our pipeline, are poised\nto benefit from escalating global market demand. This demand is primarily fueled by the demographic shift towards an aging population\nand the concurrent rise in comorbidities such as diabetes, obesity, cardiovascular ailments, and peripheral vascular diseases.\n\n \n\n30\n\n \n\n \n\nWe\neither self-develop our chronic wound care products or co-develop them through technology licensing agreements or research collaboration\nwith a renowned research university. In June 2022, we were granted an exclusive license from NTU to develop and commercialize a range\nof chronic wound care products using collagen derived from bullfrog skin. In addition, in August 2022, we entered into an industry research\ncollaboration agreement with NTU, pursuant to which both parties agreed to jointly undertake a research project regarding the development\nand validation of bullfrog skin waste to generate collagen-based wound care products. In November 2025, we entered\ninto a joint venture agreement with Aiodine Laboratory Pte. Ltd. for the worldwide distribution and sale of iodine-based\nwound care and topical antiseptic products.\n\n \n\nWe\nhave been selling our MEDIFLY products primarily in Singapore since February 2020. In March 2023, our MEDIFLY products became commercially\navailable in Hong Kong. Looking ahead, we have strategic plans in place for 2026 to expand our sales and establish physical\noperations in several key regions, including the Middle East (in particular, the member states of the Gulf Cooperation Council, or GCC),\nand mainland China. These expansion initiatives will further enable us to cater to the growing demand for our products in these promising\nmarkets, cementing our position as a trusted player in the field of chronic wound care and treatment.\n\n \n\nFor\nour cosmeceuticals business, we introduced three products in 2023, including a hydrating balm product, a muscle energy cream\nand a pain relief muscle patch. For our currently commercialized cosmeceutical products, we have commissioned original equipment manufacturers\nof skincare products to develop the formulation and manufacture the substantially finished and finished products. In addition, we plan\nto explore the possibility of developing a range of potential cosmeceutical product candidates incorporating bullfrog collagen using\nthe novel collagen production technology that we are currently developing with a view to making them commercially available between 2026\nand 2027, subject to the progress of the relevant R&D work.\n\n \n\nWe\noffer our chronic wound care products to both public and private hospitals and clinics, where patients can obtain them through prescription\nfrom a physician. Our customers primarily include major public and private hospitals and clinics in Singapore. Our commercialized cosmeceutical\nproducts can be purchased directly by individual customers through a variety of channels, including retailers and gyms in Singapore and\nother countries such as Malaysia and Australia, as well as online shopping platforms such as Shopee.\n\n \n\nOur\ncommitment to quality is demonstrated by our attainment of ISO 13485:2016 standards for Quality Management Systems and Manufacturing\nProcesses and Controls for our manufacturing facility located in Singapore in 2020. We are working towards obtaining compliance with\nFDA’s Quality Management System Regulation, an integral component of the Current Good Manufacturing Practice, or CGMP, regulations,\nto secure FDA 510(k) clearance for our chronic wound care products, including both our existing commercialized products and forthcoming\nproducts in our pipeline.\n\n \n\nAs\nof December 31, 2025, we had 10 full-time employees. For the years ended December 31, 2023, 2024, and 2025, our revenue amounted to S$100,773,\nS$48,321 and S$49,894 (US$38,789), respectively, while we recorded net loss of S$1,119,555, S$1,560,535 and S$4,673,447 (US$3,633,248),\nrespectively, for the same periods.\n\n \n\n**Our\nCompetitive Strengths**\n\n \n\nWe\nbelieve that the following competitive strengths have contributed to our past success and will continue to distinguish us from our competitors:\n\n \n\n**Innovative\nproduct portfolio that differentiates us from our competitors**\n\n \n\nWe\nbelieve our portfolio of current and pipeline products sets us apart from competitors in the medical industry. Specifically, our bioactives\npossess distinctive properties that enable us to generate medical derivative products with improved performance compared to conventional\ntreatments in the market and sets us apart from competitors in the relevant industry, as supported by statistically significant clinical\nand health economic outcomes data. For example, our current maggot-based chronic wound care products are able to disinfect wounds and\naccelerate the healing process for chronic wounds for patients who are not responsive to conventional treatments. In addition, hirudotherapy,\nthe mechanism underpinning our pipeline product utilizing medical grade leeches, has been traditionally used for bloodletting and treating\ninflammation, thrombosis, phlebitis, varicosity, and pain in traditional medicine in certain parts of the world and has been investigated\nfor effectiveness in treating non-healing chronic wounds, including ulcerated wounds and diabetic foot ulcers, or DFUs in a number of\nclinical studies. Through our joint venture with Aiodine Laboratory Pte. Ltd., we also intend to commercialize iodine-based\nwound care and topical antiseptic products, further broadening our product portfolio across the wound care continuum.\n\n \n\nWe\nbelieve the efficacy of our MEDIFLY products will result in expanded adoption of our products at a lower overall cost to payors. In addition,\nour portfolio of current and pipeline products will allow doctors and clinicians to provide personalized therapeutic solutions to meet\nthe needs of individual wound care patients covering major stages of the wound healing process, from chronic to closure.\n\n \n\n31\n\n \n\n \n\n**Well-positioned\nin large and growing chronic wound care markets**\n\n \n\nWe\nbelieve the chronic wound care market is poised to experience continuous accelerated growth due to a number of global trends such as\nan aging population, rising healthcare costs, increasing awareness of difficult-to-treat infections like Methicillin-resistant Staphylococcus\nAureus, or MRSA, and a growing prevalence of diabetes and obesity. Given the expanding chronic wound care market, our products are strategically\npositioned for widespread adoption as they are designed with a specific focus on cost-effectiveness and cater to the needs of patients\nsuffering from chronic wounds.\n\n \n\nOur\nfocus is to provide products that are not only more effective than competing options but also offer a stronger value proposition, which\nincludes lower total costs and reduced healing time, ultimately leading to lower costs for the healthcare system. We believe that this\napproach is particularly effective in the geographic markets where we intend to enter in the near future, such as mainland China, which\nis a developing economy with a large and rapidly aging population and has strong demands for affordable and effective wound care solutions.\n\n \n\n**Access\nto innovative technology in developing pipeline products**\n\n \n\nWe\nhave been forging relationships with a renowned research university, which we believe have helped us gain access to innovative technology\nin developing pipeline products. In particular, we have been granted the exclusive license from NTU in June 2022, to develop\nand commercialize a range of chronic wound care products using collagen derived from bullfrog skin and possess many beneficial properties\nwhen compared to other conventional sources of collagen including superior biocompatibility, solubility and thermal stability, and reduced\ndisease and allergy risks, among others. In addition, we have been developing related chronic wound care products utilizing bullfrog\ncollagen, including sponge dressings and hydrogels through our research collaboration with NTU. Furthermore, researchers at NTU are constantly\nupgrading current formulations and introducing new formulations of the bullfrog collagen based on evolving trends in the medical device\nindustry.\n\n \n\nWe\nhave also entered into a joint venture with Aiodine Laboratory Pte. Ltd., through which we gain access to Aiodine’s proprietary\niodine-based technology, intellectual property, and technical expertise for the worldwide commercialization of iodine-based wound care\nand topical antiseptic products. In a pilot clinical study published in Wounds International in 2025, Aiodine’s iodine-based technology\ndemonstrated promising efficacy in facilitating wound healing across four cases of severe wounds, including infections caused by antibiotic-resistant\nbacteria, with no evidence of cytotoxicity and no significant patient discomfort reported.\n\n \n\nWe\nbelieve such a collaborative approach to product development allows us to develop multiple pipeline products in parallel without significant\nupfront investment in workforce and equipment and let us leverage our manufacturing capabilities and knowledge navigating the complex\nregulatory approval process to attract dedicated research institutions producing innovative technologies that we can commercialize.\n\n \n\n**Commitment\nto sustainability**\n\n \n\nWe\nview sustainability as a key priority, which guides our decisions when sourcing raw materials to manufacture our products. We aim to\ngrow our materials in-house whenever possible to minimize our environmental impact. As an example, our commercialized chronic wound care\nproduct utilizes maggots bred in house to debride chronic wounds, which is a sustainable approach with a small ecological footprint.\nWe plan to follow this with our pipeline chronic wound care product that utilizes medical grade leeches, which will also be bred in-house.\n\n \n\nIn\naddition, the other products in our pipeline, including bullfrog collagen-related chronic wound care and cosmeceutical products represent\nexamples of valorization processes for slaughterhouse waste for discarded bullfrog skins.\n\n \n\nWe\nbelieve our commitment to sustainability provides us with significant competitive advantages, including the ability to cater to a wider\nconsumer base by meeting the increasing demand for environmentally responsible products, as well as cost savings through efficient manufacturing\nprocesses, as we source raw materials from the wild and previously untapped waste streams, such as *Lucilia cuprina* flies and discarded\nbullfrog skins, which not only reduces waste but also minimizes production costs.\n\n \n\n**Loyal\nand growing customer base**\n\n \n\nWe\nhave established strong relationships with our customer base, which primarily consists of hospitals, clinics and other licensed facilities\nproviding medical care, resulting in a loyal following. In particular, 70.6% of customers of our chronic wound care business in 2024\ncontinued to purchase our products in 2025. We believe such customer loyalty stems from our commitment to excellent customer\nservice, reliable product quality, consistent delivery and ongoing support. This loyalty generates repeat business, maintains a steady\nrevenue stream, and benefits from positive word-of-mouth referrals.\n\n \n\n**Strong\nleadership with in-depth knowledge and expertise**\n\n \n\nOur\nleadership possesses strong management skills, operational experience and industry knowledge and expertise necessary to develop and execute\nour strategy to capture market opportunities. In particular, Dr. Ronald A. Sherman, our Medical and Scientific Director,\npossesses in-depth knowledge and expertise in the fields of entomology, biotechnology and biochemistry of chronic wounds management.\nHe has co-written papers in biochemistry, applied entomology and clinical medicine. He is also a named inventor in several patents in\nentomological product development. He has built an extensive business network and connections in the industry and throughout the scientific\ncommunity, which we believe have helped us establish a strong working relationship with key customers, suppliers and research institutions.\nHe oversees ideation, regulatory affairs, clinical affairs and communications. Mr. Quek, our CEO and a director, has a crucial role in\nthe management of our employees. Before joining us, he held various managerial positions such as business development director and marketing\nmanager in publicly-listed companies in Singapore. He has a deep understanding of our business operations and is responsible for fostering\nrelationships with our business partners and making strategic business decisions for us.\n\n \n\n32\n\n \n\n \n\nLed\nby our CEO, our management team is capable of taking advantage of market opportunities, formulating sound business strategies,\nassessing and managing risks and optimizing operational efficiencies to maximize profits. Our management is supported by a team of highly\nskilled and motivated employees. We believe our staff have high levels of professional qualification and training and are skilled and\nhighly motivated.\n\n \n\n**Our\nBusiness Strategies**\n\n \n\nTo\nachieve our business objectives, we plan to adopt the following strategies to drive our future growth.\n\n \n\n**Expand\ninto new geographic markets through strategic partnerships**\n\n \n\nWe\nplan to strengthen our market presence by expanding into new geographical regions, including Southeast Asia, the Middle East (particularly\nthe member states of the GCC), and mainland China. These regions offer significant growth potential and a growing need for improved healthcare\nsolutions, particularly in chronic wound care.\n\n \n\nTo\nachieve our strategic objectives, we have entered into various collaboration agreements with local partners in Saudi Arabia, Hong Kong,\nand mainland China. In Saudi Arabia, we have entered into a joint venture agreement with a local medical services company in May 2022\nand are currently in the process of registering medical maggots with the Saudi Food and Drug Authority, or SFDA. In Hong Kong, we have\ncollaborated with Advanced Biotech and Engineering Limited and signed an exclusive distribution and cooperation and profit-sharing agreement\nwhich took effect in June 2023. In mainland China, we have collaborated with Nan’ao (Beijing) Hospital Management Co., Ltd. for\nthe purpose of registering our maggot-based chronic wound care products with the National Medical Products Administration of China, or\nNMPA. To this end, we have entered into an Agreement to Collaborate and Protect Confidentiality in August 2022. We believe our maggot-based\nchronic wound care product will become the first live bio-dressing to be registered with the NMPA in mainland China. These collaborations\naim to facilitate market entry, secure regulatory approvals, and ensure a smooth transition into new markets. Please see “–\nOverseas Collaboration” in this section for additional details.\n\n \n\nWe\nplan to engage in further discussions with potential distribution partners in Thailand, Malaysia, Vietnam, and Indonesia.\nAs of the date of this Annual Report, we have not identified any such partners in the markets mentioned above. We believe\nleveraging strategic alliances will enable us to establish a robust distribution network and disseminate our comprehensive product offerings\nacross these regions.\n\n \n\n**Continue\nto expand our product portfolio through development and innovation**\n\n \n\nWe\nwill utilize our in-house R&D team to develop new pipeline products. In addition, we are actively collaborating with our third-party\nR&D partner, NTU, to develop an innovative process for producing bullfrog collagen from bullfrog skin that will underpin many of\nour pipeline products. Our research utilizes ethical sourcing practices and cutting-edge technology to harness the beneficial properties\nof bullfrog collagen. We are also expanding our product portfolio through our joint venture with Aiodine Laboratory Pte. Ltd., through\nwhich we intend to commercialize Aiodine’s proprietary iodine-based wound care and topical antiseptic products.\n\n \n\nOur\ngoal is to expand our current offerings to provide affordable and accessible wound care products and cosmeceutical products. In particular,\nsubject to the progress of the relevant R&D work and regulatory approval, we plan to introduce ranges of new products that utilize\nleeches, bullfrog skin-derived collagen, and iodine-based formulations in the future to address each major stage of the wound healing\nprocess. We believe this will enable clinicians and patients to better select products tailored to the appropriate stage of wound healing.\nIn addition, we plan to explore the possibility of developing a range of potential cosmeceutical products incorporating bullfrog collagen\nskincare and cosmetic products, with a view to making them commercially available between 2026 and 2028, subject to the progress\nof the relevant R&D work.\n\n \n\n**Expand\ninto new business ventures**\n\n** **\n\nWe\nintend to leverage our biomedical infrastructure and operational expertise to enter two adjacent growth areas: medical waste recycling\ntechnology and in-vitro fertilization (“IVF”) media production.\n\n \n\n*Medical\nWaste Recycling Technology*\n\n \n\nIn\nSeptember 2025, we secured exclusive licensing rights for Singapore, with an option to expand into ten additional Southeast\nAsian countries, to a medical waste recycling technology developed under the oversight of the United Nations Industrial Development Organization\n(“UNIDO”) and the Global Environment Facility (“GEF”). The license was entered into with Zhejiang Heliang Technology\nCo., Ltd., a China-based technology company. Unlike conventional incineration-based methods, which release toxic emissions\nand contribute to landfill strain, this technology employs advanced high-temperature steam treatment to sterilize and decontaminate medical\nwaste, with a particular focus on plastic-based materials. The decontaminated materials are thereafter sorted and recycled into high-value\nresins and sustainable raw materials that re-enter the economy as productive inputs. The technology has been refined and validated over\napproximately two decades through collaboration between Chinese regulatory authorities, UNIDO, and GEF, and holds ISO certifications\nacross quality, environmental, and occupational health management standards (ISO 9001, 14001, and 45001).\n\n \n\nWe\nintend to apply for the operating licenses required in Singapore to establish a facility deploying this technology, and are engaging\nwith Singapore’s leading toxic waste disposal companies to integrate our operations into the national waste management framework.\nBy establishing Singapore as the first hub for this technology outside of China, we aim to capture significant commercial opportunities\nacross Southeast Asia, where governments are increasingly tightening environmental standards governing healthcare waste. In Singapore\nalone, biohazardous medical waste volumes grew from approximately 4,400 tons in 2016 to 5,700 tons in 2020, representing an average annual\nincrease of approximately 5%. According to Grand View Research, the global medical waste management market was valued at approximately\nUSD 34.06 billion in 2023 and is projected to reach approximately USD 59.42 billion by 2030, growing at a compound annual growth rate\nof approximately 8%, with Asia-Pacific identified as the fastest-growing region.\n\n \n\n*IVF\nMedia Production*\n\n \n\nIn\nApril 2025, we completed construction of an IVF media production facility in Singapore, which has received ISO 13485 certification\nissued by the United Kingdom Accreditation Service (“UKAS”), a member body of the International Accreditation Forum\n(“IAF”), and a dealer license issued by the Singapore Health Sciences Authority (“HSA”). The facility was\nbuilt in collaboration with Ferti-Craft Pte Ltd. (“Ferti-Craft”), a Singapore-based medtech company specializing in\nhuman Assisted Reproductive Technology (“ART”). The facility is intended to produce 14 stock-keeping units\n(“SKUs”) of IVF media products containing the nutrients, electrolytes, amino acids, and other biological materials\nrequired to support the fertilization of sperm and ovum in an in-vitro laboratory setting.\n\n \n\nWe\nare collaborating with Ferti-Craft to prepare and submit the regulatory dossiers required for product registration with HSA, with the\ngoal of obtaining approval for all 14 IVF media SKUs and commencing commercial sales before the fourth quarter of 2026. Under our arrangement,\nFerti-Craft is responsible for all necessary documentation and testing, raw material logistics, and contributes the intellectual property,\nsubject matter expertise, and production know-how in respect of these products. Subject to obtaining the necessary regulatory approvals,\ninitial sales are expected to be primarily in Singapore, with a planned expansion into select ASEAN countries, the Middle East, and other\nglobal markets thereafter. According to Global Market Insights, the total ART market was valued at approximately USD 38.9 billion in\n2025 and is expected to grow at a compound annual growth rate of approximately 7.6% to reach approximately USD 79.8 billion by 2035,\ndriven by the rising prevalence of infertility and growing global acceptance of ART.\n\n \n\n**Strengthen\nbrand awareness, and acquire and retain customers**\n\n \n\nTo\ndate, our efforts to promote our products and increase brand awareness have focused on participating in various conferences and holding\neducational talks in key existing and potential markets. For example:\n\n \n\n \n●\n*Singapore*:\nbetween 2021 and 2026, we have participated in multiple webinars and educational talks in collaboration with various organizations\nsuch as St. Luke’s Elder Care, Convatec Academy for Professional Education, Podiatry Association (Singapore), and Vascular\n& Intervention Center, to discuss the clinical application and future potential of MDT for wound care. We also conducted educational\ntalks at hospitals and institutes such as Woodlands Hospital, Mount Alvernia Hospital, Farrer Park Hospital, Mount\nElizabeth Novena Hospital, and Home Nursing Foundation to introduce and discuss the management of patients with MDT.\n\n \n\n33\n\n \n\n \n\n \n●\n*Malaysia*:\nwe participated in the First Pahang Wound Healing Conference and the Commonwealth & 4th Global Wound Conference in\nAugust 2022 and October 2022, respectively.\n\n \n\n \n●\n*Hong\nKong:*we participated in multiple conferences and delivered talks in various venues, for example, we participated in the 2026\nSymposium on Diabetic Wound Healing organized by The Hong Kong Society for Diabetic Limb Care, hosted at HKUMed – The University\nof Hong Kong, HKTDC Hong Kong International Medical and Healthcare Fair 2024, and delivered an educational talk\nat the Joint Orthopaedics and Traumatology Nursing Forum 2024 organized by Hong Kong East Cluster - Hospital Authority. We also delivered\nan educational talk at the 2023 Symposium on Diabetic Wound Healing - Recap the Essentials organized by The Hong Kong Society for\nDiabetic Limb Care, and held an education talk with the topic “Maggot Debridement Therapy for Wound Care” to the Department\nof Orthopaedics at Pamela Youde Nethersole Eastern Hospital in September 2022.  \n\n \n\nIn\naddition, as of the date of this Annual Report, we and our products had been covered by various news coverages in influential media outlets\nincluding Channel NewsAsia, South China Morning Post, Yahoo News, Healthcare Asia, Taiwan Health News, TODAY News, and 8world News, among\nothers.\n\n \n\nGoing\nforward, we plan to increase our brand visibility and boost sales growth through marketing activities utilizing a combination of traditional\nchannels, such as print media, targeted advertising campaigns and trade shows and digital channels, such as social media, content marketing\nand email and online advertising to maximize the reach and impact of our promotional efforts. This comprehensive set of avenues\nallow us to achieve targeted messaging, audience segmentation, and real-time performance tracking, enabling us to optimize marketing\ncampaigns for maximum effectiveness.\n\n \n\nIn\nparticular, we plan to acquire and retain customers through tailored marketing campaigns emphasizing personalized healthcare services\nand comprehensive patient education. By crafting campaigns that resonate with specific groups such as aging patients, clinicians, caretakers\nand other healthcare professionals, we plan to highlight the value proposition of our products and position ourselves as a preferred\nprovider. We also plan to provide comprehensive patient education resources, such as informative brochures, online content, and interactive\nworkshops, to educate the patients on their conditions, available treatment options, and the importance of proactive healthcare management.\n\n \n\n**Attract,\ncultivate and retain a talented and professional workforce**\n\n \n\nWe\nbelieve that a significant part of our success is attributable to our ability to select, develop, motivate and retain our talented and\nprofessional workforce. We will continue to strengthen our team and proactively recruit, retain and train talents for our sales and marketing\nand R&D teams. We plan to recruit approximately four sales and marketing personnel and four R&D staff in the next two years.\n  \n\n \n\nWe\nwill focus on cultivating the industrial knowledge of our workforce with training and professional development programs such as workshops,\nseminars, mentorship programs, and opportunities to participate in industry conferences or events, collegial working environment, competitive\ncompensation structure as well as internal promotion opportunities to enhance their creativity, loyalty, job satisfaction and cohesiveness.\n\n \n\nIn\norder to foster the growth of future talent, we have successfully established internship programs with prestigious educational institutions\nin Singapore, namely, the National University of Singapore, NTU, and Republic Polytechnic. These programs serve as valuable platforms\nfor students of these institutions to gain practical experience and apply the knowledge they have learned in the classroom to real-world\nsituations and allow us to identify and recruit talented students who we consider as a good fit for us.\n\n \n\n**Industry\nOverview**\n\n \n\n**Chronic\nWound Care Business**\n\n \n\n*Market\nOpportunities for Our Chronic Wound Care Products*\n\n \n\nWounds\nrepresent a large and growing burden on the public health as well as a significant cost to the health care system. Wounds are divided\ninto two primary types, chronic and acute. According to an article published in The Annals of Epidemiology in 2019, the global prevalence\nof chronic wounds is estimated at 1.51 to 2.21 per 1,000 population. As a result, it is estimated that up to 17.7 million people suffer\nfrom chronic wounds globally each year. According to Fortune Business Insights, the market size for the global chronic wound care market\nwas US$15.27 billion in 2025 and is expected to reach US$29.22 billion in 2034, representing a CAGR of 7.5% from 2026 to 2034.\n\n \n\n34\n\n \n\n \n\nWound\nhealing involves a complex and dynamic process that occurs in three distinct stages. Wounds may stall during this process and become\nnon-healing and chronic, typically in the inflammatory phase, for a variety of reasons. These reasons include biofilm or infection, uncontrolled\ninflammatory processes, shortages of cell types and growth factors secreted by cells that are critical to healing and disrupted cell\nsignaling pathways. Below are the main stages of wound healing:\n\n \n\n \n\n****\n\nThe\ninflammation stage is a defensive stage when white blood cells are dispatched. Chronic wounds fail to proceed through the normal\nphases of wound healing in an orderly and timely manner often stalling in the inflammation phase.\n \nDuring\nthe proliferation stage, various cellular activities occur to facilitate wound healing and it is a crucial stage for the formation\nof new tissue and the restoration of wound strength.\n \nDuring\nthe maturation stage, the newly formed tissue undergoes remodeling and strengthening. The healed tissue gains strength and durability\nas collagen fibers become more structured. Blood vessels within the tissue mature, ensuring proper blood supply. Scar tissue becomes\nless prominent over time.\n\n \n\nChronic\nwounds are a growing problem globally, driven primarily by the aging population and the prevalence of lifestyle diseases such as diabetes.\nThe cost of healthcare has also been on the rise in most countries, and the persistence of difficult-to-treat infections further compounds\nthe issue. These factors create a complex landscape for managing chronic wounds. Primary examples of chronic wounds include diabetic\nulcers, venous ulcers, arterial ulcers, pressure ulcers and traumatic ulcers. In each of the various wound types, the presence of biofilms\nis a frequent cause for chronic wounds and the removal of biofilms is a crucial step to commence healing. Biofilms need to be eradicated\nto prevent further deterioration of the wound that may result in additional negative patient outcomes. If not effectively treated, these\nwounds can lead to potentially severe complications, including further infection, osteomyelitis, fasciitis, amputation and increased\nmortality,\n\n \n\n*Diabetic\nUlcers.* Diabetes can lead to a reduction in blood flow, which can cause patients to lose sensation in their feet and may prevent\nthem from noticing injuries, sometimes leading to the development of diabetic ulcers, which are open sores or ulcers on the feet that\nmay take several weeks to heal, if ever.\n\n \n\n*Venous\nUlcers.* Venous ulcers develop as a result of vascular insufficiency, or the inability for the vasculature of the leg to return blood\nback toward the heart properly. These ulcers usually form on the sides of the lower leg, above the ankle and below the calf, and are\nslow to heal and often recur if preventative steps are not taken. The risk of venous ulcers can be increased as a result of a blood clot\nforming in the deep veins of the legs, obesity, smoking, lack of physical activity or work that requires many hours of standing.\n\n \n\n*Pressure\nUlcers.* Pressure ulcers, also known as decubitus ulcers or bed sores, are injuries to skin and underlying tissue resulting from prolonged\npressure, or pressure in combination with shear or friction. Constant pressure on an area of skin reduces blood supply to the area and\nover time can cause the skin to break down and form an open ulcer. These often occur in patients who are hospitalized or confined to\na chair or bed and most often form on the skin over bony areas, where there is little cushion between the bone and the skin, such as\nheels, ankles, hips and the tailbone.\n\n \n\n*Traumatic\nUlcers.* Traumatic wounds form as a result of cuts, lacerations or puncture wounds, which have caused damage to the skin and underlying\ntissue. Severe traumatic wounds may require surgical intervention to close the wound and stabilize the patient. Traumatic hard-to-heal\nwounds develop for various reasons, such as local surgical complications, suboptimal closure techniques, presence of foreign materials,\nexposed bones or tendons and infection. Millions of people receive post-surgical wound care annually, and the typical operative patient\nhas comorbidities that create challenges with post-operative wound healing.\n\n \n\n*Arterial\nUlcers.* Arterial ulcers are a type of chronic wound that typically occurs on the lower legs, feet, or toes. These ulcers are caused\nby reduced blood flow to the affected area, usually due to underlying conditions such as peripheral artery disease (PAD) or atherosclerosis.\nArterial ulcers can be painful and slow to heal, and if left untreated, can lead to serious complications such as infection or tissue\ndamage. Effective treatment of arterial ulcers requires a comprehensive approach that addresses the underlying causes of reduced blood\nflow, promotes healing, and prevents further complications. In this context, innovative wound care solutions and a patient-centric approach\ncan play a crucial role in improving outcomes and enhancing the quality of life for those affected by arterial ulcers.\n\n \n\n35\n\n \n\n \n\n**Market\nScale**\n\n \n\n*Mainland\nChina and Hong Kong*\n\n \n\nAccording\nto a report published by Mordor Intelligence, the wound care management market size in China is estimated at USD 1.04 billion in 2026,\nand is expected to reach USD 1.39 billion by 2031, growing at a CAGR of 6.02% from 2026 to 2031.\n\n \n\nMainland\nChina is getting more requests for wound care management because the number of chronic wounds is going up. Articles published by the\nNational Library of Medicine in 2021 and the Chinese Journal of Traumatology in 2023 stated that diabetes, infection, pressure, and trauma\nwere the most common reasons for chronic wounds on the skin in mainland China. The high incidence of diabetes in mainland China is a\ndefining characteristic of the region, and as a result, there is an increasing need for wound care management to lower the risk of slow-healing\nwounds in diabetic patients. As ulceration of the foot in diabetes is common and disabling and frequently leads to amputation of the\nleg, the incidence of chronic wounds, especially foot ulcers, increases among the diabetic population. For instance, in 2021, the International\nDiabetes Federation, or IDF, reported that the number of diabetic cases reported in mainland China in 2021 was 140.9 million, which accounted\nfor 10.6% of mainland China’s population, and this number is expected to increase by 164.06 million by 2030. According to a clinical\nstudy published in the Chinese Journal of Diabetes Mellitus in 2021, the annual prevalence of DFUs in mainland China is 8.1% in patients\nwith diabetes, which translates into the number of DFU patients at around 11.4 million. According to a clinical paper published in Diabetes,\nMetabolic Syndrome and Obesity: Targets and Therapy in 2020, the average cost for curing DFUs per person is RMB21,827 (US$3,093). Thus,\nhigh cases of diabetes are marked by a high incidence of DFUs, thereby increasing the demand for diabetic foot care management in mainland\nChina.\n\n \n\nAccording\nto a report published by P&S Intelligence, the wound dressing market in Hong Kong reached a value of US$40.1 million in 2020 and\nis projected to grow at a CAGR of 6.0% between 2021 and 2030. Similar to mainland China, the major factors leading to the growth of the\nHong Kong market are rising prevalence of diabetes, high incidence of traumatic injuries, and growing geriatric population.\n\n \n\n*Gulf\nCooperation Council (GCC)*\n\n \n\nAccording\nto a report published by IMARC Group, the projected expansion of the wound care market in the GCC nations is expected to achieve a CAGR\nof approximately 5.39% during 2025 to 2033. This projected growth can be attributed to a notable increase in the number of people suffering\nfrom chronic wounds such as DFUs, venous leg ulcers, cavity wounds, and skin abrasions. For example, according to the data presented\nby the International Diabetes Federation, 12.3% of the population in the UAE, equating to roughly 990,900 individuals, had diabetes in\n2021. Given the evident manifestation of chronic wounds in the GCC nations, particularly in the form of foot ulcers among diabetic patients,\nthe healthcare infrastructure in GCC nations has grappled with a surge in chronic wound cases over recent years. These conditions necessitate\nthe incorporation of more advanced wound healing methodologies within healthcare facilities as well as the increase in investment by\nthe government in the healthcare infrastructure to encourage research and development activities aimed at addressing wounds. In addition,\nthe growing geriatric population in the region has necessitated wound care facilities to provide wound care solutions that enable faster\nrecovery.\n\n \n\n*Southeast\nAsia*\n\n \n\nAccording\nto a report published by Grand View Research, the Southeast Asia market for advanced wound care had a value of US$221.3 million in 2022\nand is anticipated to grow at a CAGR of 6.1% from 2023 to 2030. The growth of the market is driven by various factors, including the\nrising incidence of chronic diseases such as diabetes and obesity, which cause chronic wounds like DFUs, pressure ulcers, and VLUs. For\ninstance, diabetes was reported to contribute to 87% of arterial insufficiency ulcers in Singapore’s population, according to data\npublished by the Singapore government. Furthermore, Indonesia had around 7.9 million adults with undiagnosed diabetes aged between 20\nand 79 in 2019, according to IDF Diabetes Atlas. The healing of such chronic wounds requires advanced wound care products, thereby driving\nmarket growth.\n\n \n\nBesides,\nthe rising prevalence of obesity is another factor propelling market growth as it is associated with chronic wounds and lower extremity\namputations. Obese individuals are at a higher risk of pressure ulcers due to reduced vascular activity in adipose tissue, and their\ninability to reposition themselves in bed increases the likelihood of pressure-related injuries. Additionally, the skin folds on their\nbodies provide an ideal environment for microorganisms to thrive, leading to ulcers. Hence, the demand for advanced wound care products\nis expected to increase, leading to market growth.\n\n \n\n36\n\n \n\n \n\nIn\nparticular, Singapore is projected to witness the fastest growth rate in Southeast Asia with a CAGR of 7.6% from 2023 to 2030. An increase\nin the number of surgeries, the presence of well-developed healthcare infrastructure, and the rise in medical tourism is among the major\nfactors driving the market. Moreover, according to the International Trade Administration of the United States, the Singapore healthcare\nmarket is expected to grow to US$49.4 billion by 2029. Singapore’s healthcare spending comprises private and public expenditures,\naccounting for 5.9% of its total gross domestic product, which is expected to increase to 9.0% by 2029. According to the World Health\nOrganization, Singapore has achieved a world-class healthcare system, which makes the country a preferred medical destination. Therefore,\nthe aforementioned factors are expected to help the advanced wound care market grow in Singapore.\n\n \n\n*The\nUnited States*\n\n \n\nAccording\nto a report published by Fortune Business Insights, the U.S. chronic wound care market size was worth US$ 4.43 billion in 2023 and is\nprojected to grow at a CAGR of 6.8% from 2024 to 2032.\n\n   \n\nThe\nsurging prevalence of chronic diseases, such as diabetes, systemic illness, and others is one of the predominant factors increasing the\nrisk of developing hard-to-heal wounds, such as venous leg ulcers, pressure ulcers, and others. Furthermore, the demand for chronic wound\ncare products will surge in the forecast period owing to the rising prevalence of chronic diseases and associated complications among\nthe geriatric population. Due to restricted and limited mobility, old-aged people are more prone to develop chronic wounds such as pressure\nulcers. For instance, according to the report published by the Administration for Community Living, the number of people aged 65 years\nand above living in the U.S. was about 54.1 million in 2019 and was anticipated to reach 80.8 million in 2040.\n\n \n\nFurthermore,\naccording to an article published in National Center for Biotechnology Information in 2021, pressure ulcers affect approximately one\nmillion to three million people annually in the U.S.\n\n \n\nMoreover,\nfactors such as rising awareness regarding proper wound care among patients, increasing new product approval and launches, and others\npromote the U.S. chronic wound care market growth in the forthcoming years. During the COVID-19 pandemic, the market witnessed slow growth\ndue to reduced patient visits to hospitals and clinics and disruption in demand and supply chain.\n\n \n\n**Our\nProducts**\n\n \n\nOur\nchronic wound care business revolves around innovating and manufacturing products for healthcare professionals and their patients. Our\ncurrently available products and pipeline products aim to provide a suite of wound care products underpinned by bio-therapeutics and\nbullfrog collagen platform technologies covering each major stage of the wound healing process. The products that we currently offer\nand those in the pipeline are derived from medical techniques that have been used for centuries in many parts of the world. We modernize\nand advance these medical techniques based on modern medical standards and processes to improve patient outcomes and enhance the efficiency\nof healthcare providers. Clinical and scientific studies demonstrate that when these products are used correctly, they can expedite healing\nand significantly reduce the overall cost of care.\n\n \n\nIn\naddition, beginning in April 2023, we launched and began generating revenue from our newly-established cosmeceuticals business. We introduced\none hydrating balm product in the first half of 2023 and two additional products, namely, a muscle energy cream and a pain relief muscle\npatch, in the fourth quarter of 2023.\n\n \n\n**Our\nChronic Wound Care Products**\n\n \n\n*Commercialized\nProducts*\n\n \n\nAs\nof December 31, 2025, we had fully commercialized one distinct line of chronic wound care products which utilizes a biological debridement\nmethod using sterile maggots to provide *in situ* wound care in a procedure known as MDT. We marketed such line of products under\nthe MEDIFLY brand name. Such product line accounted for 71.2% of our revenue in 2024, and 88.6% of our revenue for the year ended December\n31, 2025. Our MEDIFLY products are used in hospitals, wound clinics and veterinary clinics for the non-surgical removal of\nnecrotic, sloughy or infected tissue from chronic wounds. Made from live, disinfected medical-grade maggots belonging to the blowfly\nspecies *Lucilia cuprina*, these bio-dressings secrete enzymes and antimicrobial compounds that make them efficient in the removal\nof sloughy and devitalized tissue, the disruption of biofilm formation, and the reduction of pathogenic infections found commonly in\nchronic wounds. Our MEDIFLY products are also used to combat infections of the wound that contain antibiotic-resistant microbes, reducing\nthe dependence on antibiotics.\n\n \n\n37\n\n \n\n \n\nMEDIFLY\nproducts are offered in two variants, namely, “MEDIFLY Free Range” and pre-sealed “MEDIFLY Baggots”. Different\nvariants are used to address different patient needs and clinical settings. In the “MEDIFLY Free Range” variant, the disinfected\nmaggots are placed on a gauze and administered directly onto the wound beds. They are allowed to roam freely on the wound beds. The “MEDIFLY\nBaggots” variant consists of disinfected maggots confined in a polyester pouch. The fabric of the pouch contains perforations that\nallow the maggots to feed through without exiting the pouch. Each of these products contains 150-250 live medical-grade *Lucilia cuprina*larvae and are made to order by clinicians. Maggots assist the wound healing process by softening, dissolving and digesting sloughy\nand devitalized tissue through the action of orally secreted proteolytic enzymes. In the process of ingestion and digestion, antimicrobials\nin the digestive system of these maggots are secreted to the wound beds. These antimicrobials disrupt biofilm formation and kill bacteria\ncolonies, making them easier to ingest and digest. The maggots in our MEDIFLY products are placed on the wound and removed after 48 to\n72 hours, signaling a single cycle of treatment. On average, three cycles of MEDIFLY treatment are sufficient to achieve a positive clinical\noutcome.\n\n \n\nBoth\n“MEDIFLY Free Range” and “MEDIFLY Baggots” variants had become commercially available in Singapore and Hong Kong\nin February 2020 and March 2023, respectively, and can be prescribed by a licensed clinician and applied by a trained medical care professional.\nWe intend to introduce the products into new markets including mainland China, Southeast Asia, and Saudi Arabia. For more details on\nregulatory approvals of MEDIFLY, please see “– Government Regulation – Our Regulatory Roadmap and Approval Timeline”\nin this section.\n\n \n\n*Selected\nPublished Clinical Studies on Our Commercialized Products*\n\n \n\nSelected\nClinical Studies on MDT\n\n \n\nClinical\nstudies have investigated the efficacy and safety of MDT for the treatment of chronic wounds. According to a study published in Evidence-Based\nComplementary and Alternative Medicine in 2014, a cohort of 63 patients with 92 pressure ulcers was studied over a minimum period of\neight weeks. The patients received either standard wound care prescribed by the hospital’s wound care doctors or maggot therapy\nconsisting of two cycles per week. The findings revealed that maggot-treated wounds underwent debridement four times faster compared\nto wounds in the control group, with a debridement rate of 0.8 cm2/week compared to 0.2 cm2/week\nin the control group. In addition, the time to healing was approximately 19 weeks shorter in the MDT treatment group compared to the\nconventional treatment group. In one of the largest clinical MDT studies to date published in the Journal of Wound Care in 2012, 723\nambulatory and hospitalized patients were treated with MDT. Among these patients, 90.5% had leg ulcers, and 48% had DFUs. The study found\nthat complete debridement was achieved in 82.1% of the cases, with a mean treatment length of 4.65 days.\n\n \n\nIn\naddition, MDT has been investigated for its effectiveness in treating wounds when compared to conventional treatments. In an article\npublished in the Asian Journal of Surgery in 2013, the researcher presented findings derived from a retrospective cohort study which\nobserved 111 diabetic patients, with 59 patients receiving MDT and 52 patients receiving conventional therapy. The study demonstrated\nthat ulcers treated with MDT had approximately seven times higher chances of wound healing compared to conventional therapy. According\nto another study published in Evidence-Based Complementary and Alternative Medicine in 2014 regarding a prospective randomized clinical\ntrial involving 72 patients revealed notable differences in the effectiveness of Vacuum-Assisted Closure, or VAC and MDT. In the VAC\ngroup, only 18.2% of patients had their wounds successfully closed, whereas 92.3% of patients in the MDT group experienced wound closure.\nIn addition, the study reported that 69.6% of patients receiving VAC therapy required amputation, while only 7.7% of patients receiving\nMDT had to undergo amputation.\n\n \n\nMDT\nhas also been investigated for its effectiveness in eradicating biofilms, the presence of which is a frequent cause for chronic wounds\nand the removal of which is a crucial step to commence wound healing. According to an article published in Applied and Environmental\nMicrobiology in 2013, the excretions/secretions of maggots are effective in disrupting the growth of bacterial biofilms. Another article\npublished in Medical and Veterinary Entomology in 2012 similarly showed that maggot deoxyribonuclease is a competent enzyme with the\npotential to assist in clinical wound debridement by removing extracellular DNA from tissue and biofilm, and promoting tissue viability,\nwhile liberating proteinaceous slough/eschar for debridement.    \n\n \n\n*Selected\nClinical Studies on our MEDIFLY products*\n\n \n\nSeveral\nrecent research findings involving MEDIFLY products have been noted in scientific literature. For example, in a clinical study conducted\nin Singapore in 2022, our MEDIFLY products were utilized for MDT in a challenging patient population. The study, highlighted in an article\npublished in Wounds Asia in 2022, focused on a patient group comprised individuals with diabetes, with accompanying complications of\nhypertension (90.9% of the patient group) and ischaemic heart disease (72.3% of the patient group). The patients’ age ranged from\n51 to 81 years, with an average age of 64 years. The study’s results demonstrated that MDT using our MEDIFLY products is a safe\nmethod of debridement. Furthermore, the pain resulting from MDT was found to be easily manageable. The study further revealed a high\nlimb salvage rate of 90.9% among the patient group. Furthermore, according to an article published in the Journal of Tissue Viability\nin 2022 describing the use of our MEDIFLY products at a Singapore hospital, patients with non-viable tissue or who could not tolerate\nsharp debridement were recruited and our MEDIFLY products were applied by wound specialists. 14 patients participated in the study, with\nthree receiving pre-sealed larvae therapy and 11 receiving free-range larvae therapy. As a result of the MDT, a reduction of non-viable\ntissue was observed in 78.6% of patients, out of which 90.9% of patients achieved successful debridement (at least 25% reduction in non-viable\ntissue).\n\n \n\n38\n\n \n\n \n\nIn\na separate article published in Wounds Asia involving a single patient study conducted in Hong Kong in 2023, a 98-year-old patient with\nan advanced stage pressure ulcer who are unsuitable for surgical operation was treated with multiple cycles of MDT using our MEDIFLY\nproducts. During the course of the treatment, the patient’s condition showed steady improvement and the patient did not report\nany discomfort or show any major unwanted effects. In addition, the article concluded that MDT could improve the condition of the wound\nin a short period of time and can also be conveniently conducted outside of a hospital by a nurse, marking its potential in reaching\na wider range of patients including older people and people with mobility problems who have difficulty in travelling to hospital frequently.\n\n \n\nIn\na further case report presented at the Hospital Authority Convention 2025 in Hong Kong, our MEDIFLY products were utilized in the treatment\nof a 90-year-old patient who suffered a 33% total body surface area (“TBSA”) deep to full thickness scald injury to her perineum\nand legs. The patient had multiple comorbidities and was assessed as unfit for surgery under general anesthesia. Initial chemical debridement\nwas first employed to thin the necrotic tissue, following which MDT using our MEDIFLY products was applied to remove the recalcitrant\neschar. The patient showed successful management of her burns and was discharged home in January 2025. The case report described this\nas the first reported use of maggot therapy to successfully debride burns in Hong Kong, and noted that MDT may offer a viable treatment\npathway in future cases of large burns in elderly or frail patients who are not candidates for surgical intervention.\n\n    \n\n*Our\nPipeline for Wound Care Products*  \n\n \n\nWe\nhave a robust pipeline of products under development under our chronic wound care business based on our platform technologies, namely,\nbio-therapeutics and bullfrog collagen. We believe our pipeline efforts will expand our portfolio of offerings as well as allow us to\naddress additional clinical applications.\n\n \n\nHirudotherapy\n\n \n\nWe\nare currently developing a product using hirudotherapy, or medical leech therapy, which involves the use of sterile, medical-grade leeches\nfor wound treatment. When these leeches bite into targeted areas, they release compounds into the wound, improving blood flow and promoting\nwound healing. These compounds include hirudin, a powerful anti-thrombin that helps maintain blood flow as the leech feeds, and calin,\nwhich binds to collagen and neutralizes its capacity to induce blood clotting.\n\n \n\nOur\nmedical leech therapy product will be commercialized through Cuprina MENA Co. Ltd, our 49%-owned affiliate, which has secured exclusive\nrights from Biopharm UK Ltd, the world’s leading provider of medicinal leeches, to sell medicinal\nleeches across the Gulf Cooperation Council countries. BioPharm, established in 1812, is based in South Wales, United Kingdom. Its intended\npatient demographics include patients with venous congestion and osteoarthritis, as well as in veterinary surgery, especially to help\ntreat polycythaemia vera, a chronic blood cancer. The product is intended to be used in government and private hospitals, specifically\nin departments such as vascular surgery, wound care and plastic and reconstructive surgery, as well as in public and private clinics.\n\n \n\nWe\nbegan the relevant R&D work for such product in June 2023. As of December 31, 2025, we have completed the ideation phase of the project\nand commenced the literature review stage. We expect to complete the development of the product over the course of 2026 and 2027.\nSuch product will become commercially available subject to us receiving the necessary regulatory approvals from the relevant authorities\nin the intended markets where we plan to introduce it. We intend to make this product commercially available first in Singapore.\n\n \n\nWe\nplan to make our medical leech therapy product available available across the MENA region and GCC countries through Cuprina MENA. Cuprina\nMENA is currently working towards obtaining the regulatory approvals required to sell the therapy in the MENA region, including the Saudi\nFood and Drug Authority license and ISO 13485 certification. As of the date of this Annual Report, no filing has been submitted by\nus for this product in any country or region. However, regulatory agencies have considered and approved the use of medical leeches in\nthe past. In June 2004, the U.S. Food and Drug Administration, or the FDA, which is an important reference agency for\nregulatory agencies in other countries, for the first time received request and approved the commercial marketing of leeches for medicinal\npurposes in skin grafts and reattachment surgery.\n\n \n\n*Bullfrog\ncollagen related products*\n\n \n\nWe\nare currently developing a product range using collagen derived from bullfrog skin sourced from waste streams for novel medical wound\ncare dressings. We intend to market such products under the ANURAN brand name and to trademark the brand name “ANURAN”. As\nof the date of this Annual Report, we have not initiated the process of trademark registration.\n\n \n\nOur\nfirst bullfrog collagen product will be a medical device in the form of a sponge dressing. The underlying working mechanism of the sponge\ndressings involves the direct contact of the dressings with the wound beds, serving to provide a scaffold and biochemical pathway to\nrecruit fibroblasts post-debridement. Bullfrog collagen is highly absorbable and will be able to assist in the management of wound exudate,\nreduction in inflammation and facilitate granulation leading to closure at the wound site. Our bullfrog collagen sponges will contain\na microporous scaffold environment which enables native cells to colonize and rebuild tissue, promoting natural healing. Bullfrog collagen\nis more biocompatible than traditional bovine/mammalian sources, contains more tensile strength, and possesses better thermostability\nthan marine sources. With these unique properties, we believe bullfrog collagen products have the potential to revolutionize the way\nwounds are managed, facilitating accelerated wound closure rates through natural healing. To our knowledge, as of December 31, 2025,\nno wound dressings using bullfrog collagen were available in any markets worldwide.\n\n \n\n39\n\n \n\n \n\nThe\nrelevant R&D work for our bullfrog collagen sponge dressings began in May 2022, and we have completed the set-up of our CGMP-compliant\npilot production facility for the extraction and formulation of the sponge dressings in our laboratory in Singapore in July 2023. We\nhave since optimized a new manufacturing step and are in the process of resubmitting the product for ISO 10993 biocompatibility testing.\nSubject to satisfactory biocompatibility results, we intend to commence safety and efficacy clinical trials with a local hospital partner\nin Singapore by the end of 2026. Our FDA 510(k) submission is planned to follow the completion of the ISO 10993 biocompatibility testing\nand any additional clinical or performance data requirements as may be determined by the FDA, subject to the progress of the relevant\nR&D work and regulatory requirements. Obtaining an FDA 510(k) clearance holds significant value as it facilitates streamlined medical\ndevice regulatory filings, such as the abridged route for HSA and SFDA, as the FDA is a recognized reference agency in these countries.\nFor a description of the relevant laws and regulations on the application and approval framework for medical devices in different jurisdictions\nrelevant to our business operations, see “- Regulations” in this section.\n\n \n\nWe\nexpect to conduct a pre-submission to the FDA between 2026 to 2027. A pre-submission is a formal\nwritten request to the FDA to seek feedback on specific portions of the 510(k) submission. The FDA notes that early interaction with\nthe FDA (such as through a pre-submission) may improve the quality of submissions and shorten total review times.\n\n \n\nWe\npreviously completed the ISO 10993 biocompatibility tests in August 2024. Following the optimization of a new manufacturing step, we\nare in the process of resubmitting the product for ISO 10993 biocompatibility testing. In the context of our 510(k) clearance process,\nthe ISO 10993 biocompatibility tests evaluate the interactions between a medical device and living tissues or cells to assess its safety.\nThese tests are carried out to determine the potential risks associated with the device, such as cytotoxicity, sensitization, irritation,\nsystemic toxicity and implantation effects. These tests are required by regulatory authorities to ensure the compatibility of a device\nwith biological systems before it can be marketed and used. Our FDA 510(k) submission is planned to follow the completion of the ISO\n10993 biocompatibility testing and any additional clinical or performance data requirements as may be determined by the FDA, subject\nto the progress of the relevant R&D work and regulatory requirements. We intend to present our 510(k) submission to the FDA by 2027.\n\n \n\nThe\n510(k) clearance process is a regulatory pathway in the U.S. for demonstrating a new medical device’s substantial equivalence to\nan existing legally marketed device. Manufacturers submit a premarket notification to the FDA, providing detailed device information\nand comparing it to a predicate device. The FDA reviews the submission and, if complete and meeting requirements, grants 510(k) clearance\nfor marketing and selling the device in the U.S. for its intended use. For more details on the 510(k) clearance process, please see “Government\nRegulation – Laws and Regulations Relating to Medical Devices and Cosmeceutical Products – United States Regulation –\n510(k) Clearance Process” in this report.\n\n \n\nWe\nexpect our bullfrog collagen sponge dressings to fall under the category of “wound dressing with animal-derived material(s)”\naccording to the relevant categorization of the FDA. These medical devices are assigned the product code “KGN”.\nAccording to the FDA, medical devices classified under the KGN product code are considered “pre-amendments, unclassified device\ntype,” meaning that they have been in commercial distribution prior to May 28, 1976. Currently, they are regulated through the\n510(k) pathway and can be cleared for marketing if they demonstrate substantial equivalence to legally marketed predicate devices in\nterms of intended use and technological characteristics. As these devices are unclassified, there is no specific regulation associated\nwith the product code. As of the date of this Annual Report, the FDA has granted clearance to over 180 devices under the KGN product\ncode. However, despite the current unclassified status of devices under the KGN product code, the\nFDA has proposed classifying them as Class II (special controls) medical devices in October 2022.\n\n \n\nAccording\nto an article titled “Learn if a Medical Device Has Been Cleared by FDA for Marketing” published on the FDA’s website,\nonly a small percentage of 510(k)s require clinical data to support a marketing clearance by the FDA. Furthermore, according to an article\npublished in the New England Journal of Medicine in 2019, the FDA typically does not mandate premarket clinical evidence for moderate-risk\ndevices. Such evidence is requested for less than 10% of applications. According to the same article, clinical trials are typically conducted\nfor Class III medical devices. Therefore, we do not believe we will be required to conduct clinical trials to obtain FDA approval for\nour bullfrog collagen sponge dressing products. However, the final determination regarding the requirement for us to undergo clinical\ntrials lies at the discretion of the FDA, and there is no guarantee that our product will obtain FDA approval.\n\n \n\nContingent\non receiving our FDA 510(k) clearance in a timely manner, we expect the bullfrog sponge dressings to first become commercially available\nto medical device distributors in the first half of 2026 in the United States. In addition, we are taking steps to make the product commercially\navailable in Singapore. We are currently in discussion with a government healthcare group in Singapore to commence clinical trials, targeted\nfor 2025, to test for the clinical safety and efficacy of our bullfrog sponge dressing on patients in a formalized trial. The bullfrog\nsponge dressing is intended to compete with other forms of animal-derived collagen for wound care dressings currently available in Singapore.\n\n \n\n40\n\n \n\n \n\nIn\naddition to the United States and Singapore, we intend to make our bullfrog sponge dressings available in several markets including Hong\nKong, mainland China, Saudi Arabia, and countries in the ASEAN region, subject to the completion of the relevant R&D\nwork and progress of the regulatory approval by the relevant authorities.\n\n \n\nBesides\nthe bullfrog sponge dressings that make up the first phase of our bullfrog collagen line of chronic wound care products, we have commenced\nthe relevant research works into other bullfrog collagen-based wound care products. One such area of research will be a hydrogel to be\nused specifically in wound cavities. Wound dressing products using bullfrog collagen, such as the hydrogel, are expected to be on an\naccelerated regulatory timeline as the biocompatibility tests for bullfrog collagen are anticipated to be completed by the end of 2026\nto 2027. As such, we expect the bullfrog hydrogel to become commercially available thereafter.   \n\n \n\nLeveraging\nthe NTU’s industrial knowhow, we expect to manufacture our bullfrog collagen line of chronic wound care products at scale to meet\nthe demands of our chosen market. For more information regarding novel collagen production technology and our collaboration with NTU,\nplease see “– Research and Development” in this section.\n\n* *\n\n*Iodine-based\nWound Care and Topical Antiseptic Products*\n\n \n\nThrough\nour joint venture with Aiodine Laboratory Pte. Ltd., we intend to commercialise a range of proprietary iodine-based wound care and topical\nantiseptic products. Aiodine’s iodine-based product is a natural extract containing complex hydroxy iodine and polyiodic species.\nIts antimicrobial mechanism works by releasing free iodine that oxidizes pathogen nucleotides and fatty and amino acids, thereby deactivating\nbacterial proteins and DNA/RNA. In vitro testing conducted under EN 13727 standards demonstrated broad-spectrum antibacterial efficacy,\nachieving greater than 5 log reduction against key clinical pathogens including Staphylococcus aureus, Escherichia coli, Salmonella typhi,\nand Pseudomonas aeruginosa within 30 seconds of contact, performance comparable to conventional povidone iodine. Notably, Aiodine’s\nsolution demonstrated this efficacy at high dilution, which we believe reflects a meaningful formulation advantage over existing products.\n\n \n\nPreliminary\nclinical evidence published in Wounds International (2025) from a pilot study of four patients conducted at the Wound Department of the\nFirst Affiliated Hospital of Hainan Medical University, China, demonstrated promising outcomes, including infections caused by antibiotic-resistant\nbacteria, with no evidence of cytotoxicity and no significant patient discomfort reported.\n\n \n\nUnder\nour joint venture arrangement, Cuprina holds a 50.1% equity interest in the joint venture company, which holds a worldwide exclusive\nlicense to distribute, market, and commercialize Aiodine’s iodine-based products. Aiodine Laboratory Pte. Ltd. is responsible for\nthe manufacture and supply of the products to the joint venture company. Cuprina is responsible for the day-to-day management of the\njoint venture company and its worldwide sales and distribution activities.\n\n** **\n\n**Selected\nPublished Studies on Our Pipeline Products**    \n\n \n\n*Hirudotherapy*\n\n \n\nHirudotherapy\nhas been traditionally used for bloodletting and treating inflammation, thrombosis, phlebitis, varicosity, and pain in traditional medicine\nin certain parts of the world. Several clinical studies have investigated the effectiveness of hirudotherapy in treating non-healing\nchronic wounds, including ulcerated wounds and DFUs.\n\n \n\nAn\narticle published in the Asian Journal of Medical Case Reports for Traditional and Alternative Medicine in 2017 compiled a retrospective\nreview of ten patients with DFUs who had undergone hirudotherapy between 2015 and 2016. Each of these patients had had a history of sequential\nfoot ulcers. The wounds of these patients did not respond to common treatments, as the flow of blood to these ulcers were limited/insufficient\nand based on the advice of an orthopedic surgeon, amputation was ordered by the physician. The article stated that hirudotherapy was\nperformed for some patients in the group. 10 to twelve leeches were applied inside and around the patients’ wounds once every three\nto seven days, for a total of ten sessions. The patients who received hirudotherapy saw their DFUs completely cured following 40–60\ndays of this treatment.\n\n \n\nAnother\ncontrolled case series study, which was published in the Journal of the German Society of Dermatology in 2010 reported the use of medical\nleeches in reconstructive surgery for 23 patients with necrotic skin flaps and hematomas. Hirudotherapy started an average of 2.6 days\nfollowing these patients’ surgical interventions. On average, 2.6 leeches were applied to patients’ wounds, with a mean of\n1.7 treatment sessions per patient. The researcher reported that 87% of these patients (20/23) showed restitution and integration of\ntheir skin flaps after their hirudotherapy. Clinical improvement was noticed after 1.1 days on average. Although prolonged bleeding occurred,\nlasting up to two days, no further adverse reactions or complications were observed.\n\n \n\nThe\navoidance of imminent amputation is also reported by an article published in the International Wound Journal in 2016. The patient concerned\npresented with a severe non-healing DFU and faced the prospect of imminent amputation. The wound was extremely painful (rated as 80/100 mm\non a visual analogue scale), gangrenous and foul-smelling. Following the hirudotherapy, the author reported that the patient’s\npain score decreased to 0–10 mm within 20 days and no further analgesics were required. After four months, the necrotic areas\nhad disappeared, and the wound was completely healed.\n\n \n\nA\nnumber of single patient observation-based case studies published in the Asian Journal of Medical Case Reports for Traditional and Alternative\nMedicine, Traditional and Integrative Medicine and Journal of Ayurveda and Integrative Medicine between 2016 and 2017 provide further\nempirical evidence with regard to hirudotherapy in the management of chronic wounds. These reports describe the successful use of hirudotherapy\nin various patients who did not respond to conventional treatment, including the inability to use antibiotics and anti-inflammation treatments.\n\n \n\n*Bullfrog\nCollagen*\n\n \n\nThe\ncurrent study of the novel bullfrog collagen conducted by NTU has involved in vitro studies characterizing its properties and comparing\nit to existing marine and mammalian collagen, as well as in vivo studies testing its safety and efficacy in diabetic-induced animal (rat)\nmodels. Notably, as identified in these studies, the bullfrog collagen extracted by NTU, is a type 1 collagen, with an intact triple\nhelix which exists as nano-collagen fibers. The nano fibers are around 175-187% thinner than mammalian collagen fibers. In vitro tests\nshowed around 90% wound closure at the 24-hour time point, as compared to commercially available bovine collagen, which showed around\n34% closure in the same time.\n\n \n\n41\n\n \n\n \n\nIn\naddition, based on the patent application we have licensed from NTU regarding “Bullfrog skin-derived collagen,\nmaterials comprising thereof, and its application in wound healing,” as well as the research data obtained by NTU, bullfrog collagen\nis more biocompatible as shown by its rapid integration into the wound beds when used as a bio-dressing as compared to bovine collagen,\nmaking it more effective in facilitating wound closure. Bullfrog collagen is also soluble in water at a near neutral pH, which expands\nits potential use in water-based products. Furthermore, bullfrog collagen possesses greater thermal stability compared to marine-derived\ncollagen, which reduces the likelihood of the collagen denaturing on wound beds, and decreases associated storage and logistics costs.\nThese findings highlight the potential of bullfrog collagen as a beneficial biomaterial for wound care.\n\n \n\nGiven\nthat using bullfrog collagen for wound care solutions is relatively new, no studies on human trials have been identified as of the date\nof this Annual Report. We intend to commence safety and efficacy clinical trials with a local hospital\npartner in Singapore by the end of 2026.\n\n* *\n\n*Iodine-based\nWound Care and Topical Antiseptic Products*\n\n \n\nA\ncase series published in Wounds International (2025, Volume 16, Issue 1) evaluated the efficacy and safety of Aiodine’s iodine-based\nsolution in four patients presenting with various types of severe wounds at the Wound Department of the First Affiliated Hospital of\nHainan Medical University, Haikou, China. The study was an open label, single-arm pilot intervention study. The four patients, aged 42\nto 66 years, presented with severe wounds including soft tissue necrosis following an ant bite, a diabetic foot ulcer post-amputation,\na Stage 4 pressure ulcer, and purulent paronychia. Wounds were chronic refractory wounds persisting for at least two weeks without significant\nimprovement. Aiodine was topically applied once daily for up to two weeks, either as a spray or wet compress, tailored to each patient’s\nhealing response.\n\n \n\nOver\nthe course of two weeks, significant improvements in wound healing and substantial reductions in infection rates were observed across\nall four cases, with no significant patient discomfort reported. Notably, in one case involving a drug-resistant strain of Pseudomonas\naeruginosa, Aiodine’s solution was used as a wet compress to eradicate the infection prior to skin grafting. Wound discharge cultures\ntested negative after one week of Aiodine’s solution application, and subsequent bacterial cultures following the skin graft remained\nnegative. The findings suggest that Aiodine’s solution did not impede healing and exhibited no cytotoxicity to healing or grafted\ntissue.\n\n \n\nThe\nstudy concluded that Aiodine’s solution demonstrated promising efficacy in wound management, particularly against antibiotic-resistant\nbacteria, and may serve as a valuable addition to wound care protocols.\n\n \n\n*Our\nFuture Wound Care Product Candidates*\n\n \n\nWe\nare also exploring a number of additional product candidates for chronic wound care treatment that we consider to be potentially promising\nincluding, among others, insect derived bioactive compounds, and botanically derived bioactive compounds.\nAs of the date of this Annual Report, our research team has commenced initial R&D work into botanically derived bioactive compounds.\nNo substantive R&D work on insect derived bioactive compounds had commenced. We consider the below product candidates\nto be promising because of the following reasons:\n\n \n\n \n●\n*Insect\nderived bioactive compounds:* The secretions from insects such as Lucilia Sericata or Lucilia Cuprina have evolved unique biochemistry\nthat is beneficial in clinical medicine. The larvae, for instance, generate enzymes, proteins, and factors, that liquify necrotic\ntissue, inhibit the growth of bacteria and stimulate exposed tissue responses. Understanding these biochemical pathways and extracting\nand exploiting them would allow for their incorporation into our future product development.\n\n \n \n \n\n \n●\n*Botanically\nderived bioactive compounds:* Plants contain a rich diversity of bioactive compounds with pharmacological properties relevant\nto wound care. Certain naturally occurring plant-derived compounds possess well-established antioxidant, anti-inflammatory, and antibacterial\nproperties that make them potentially valuable in wound care applications. Our research team is currently investigating the incorporation\nof selected botanically derived bioactive compounds to enhance our wound care portfolio.\n\n \n\n**Our\nCosmeceutical Products**\n\n \n\nIn\n2023, we established our cosmeceuticals business in order to further profit from the technologies and expertise dealing with natural\nbioactives that we obtained from research and production of our chronic wound care products. In particular, we believe that bullfrog\ncollagen, owing to its beneficial properties as described above, will serve as the foundation ingredient in the line of cosmeceutical\nproduct candidates that we intend to explore and offer in the future. While we work to develop and refine our process of extracting,\npurifying and concentrating bullfrog collagen, we have introduced one hydrating balm product in the first half of 2023 and two additional\nproducts, including a muscle energy cream and a pain relief muscle patch in the fourth quarter of 2023, in collaboration with third party\nmanufacturers and distributors for the purpose of establishing our position as a provider of cosmeceutical products, promoting our brand\nname and building sales networks.  \n\n \n\n**Our\nCommercialized Cosmeceutical Product**\n\n \n\nAs\nof the date of this Annual Report, we had three commercialized cosmeceutical products.\n\n \n\n42\n\n \n\n \n\n*MEND\nSkin Restoration Balm*\n\n \n\nMEND\nSkin Restoration Balm is a hydrating balm that caters to the skincare needs of individuals who engage in manual labor or sports activities\nthat may cause wear or damage to their hands. We commissioned a Singapore-based OEM of skincare products for the relevant R&D work\nto create a customized formulation that meets the needs and preferences of the targeted customer base.\n\n \n\nThe\nbalm’s key ingredients include collagen and hydroxyethyl urea to provide hydration to the skin. The formulation also includes a\nblend of natural plant extracts for their skin-soothing and restorative properties. The balm is considered a cosmetic product under the\nrelevant regulations of the HSA.\n\n \n\nThe\nSingapore-based OEM manufactures the raw material under the CGMP clean room environment. We oversee the development of the balm’s\nformulation, production of the empty cosmetics tubes and logistics for raw materials. We then purchase the raw materials consisting of\nempty cosmetics tubes and cream in bulk, and fill and seal the final product at our own manufacturing facility. Full Crimp Milk LLP,\nor Full Crimp Milk, with whom we have entered into a partnership agreement, oversees the sales and marketing of MEND Skin Restoration\nBalm.\n\n \n\nThe\nmaterial terms of such agreement are set out below:\n\n \n\n**Commencement\ndate**\n \nJanuary\n26, 2023\n\n \n \n \n\n**Parties\nto the agreement**\n \n\ni.\nCuprina Pte. Ltd.\n\n \n\nii.\nFull Crimp Milk LLP\n\n \n \n \n\n**Profit\nSharing**\n \nEach\nparty shall be entitled to receive 50% of all revenues generated from the sales of MEND Skin Restoration Balm, and both parties shall\nequally contribute 50% of the capital required for development and manufacturing costs.\n\n \n \n \n\n**Our\nprimary responsibilities**\n \n\ni.\nFormulation of MEND ingredients, including sourcing for formulators that adhere to GMP standards\nto ensure quality and consistency in the product;\n\n \n\nii.\nfilling and sealing of MEND cream into the printed tubes as a finished product;\n\n \n\niii.\ndelivering the finished product to Full Crimp Milk for sales; and\n\n \n\niv.\nprovide support to Full Crimp Milk when necessary, for example, manpower support during large-scale marketing campaigns or events.\n\n \n \n \n\n**Full\nCrimp Milk primary responsibilities**\n \n\ni.\nPreparation for product launch;\n\n \n\nii.\nsales of the product, including (1) direct sales, and/or through distribution, and (2) determining the appropriate retail price of\nthe finished product that is compatible with customers’ willingness to pay and cost of the product;\n\n \n\niii.\nmarketing of the product, including through Full Crimp Milk’s social media accounts;\n\n \n\niv.\ndistribution of finished products to customers; and\n\n \n\nv.\ncollecting customer feedback to improve the product.\n\n \n \n \n\n**Termination**\n \nThe\nagreement shall terminate at a date mutually agreed upon between the parties.\n\n \n\nThe\nbalm is currently available through a variety of channels, including retailers and gyms in Singapore and other countries such as Malaysia\nand Australia, as well as online shopping platforms such as Shopee.\n\n \n\nIn\nthe future, once the novel collagen production technology becomes available, we plan to incorporate the bullfrog collagen into the balm’s\nformula as a superior substitute for the collagen in the current formula.\n\n \n\n*ENDURE\nMuscle Energy Cream*\n\n \n\nENDURE\nMuscle Energy Cream is a product designed to meet the needs of sportsmen and athletes who require a high-performing energy cream to enhance\ntheir physical performance. The cream is created using transdermal delivery technology, delivering energy directly to the muscles through\nthe skin. The cream is considered a health supplement under the relevant HSA regulations, which is not subject to approval and licensing\nby HSA for the manufacture and sales of the product in Singapore.\n\n \n\n43\n\n \n\n \n\nENDURE\nMuscle Energy Cream combines ribose, creatine, carnitine and caffeine to relieve muscle fatigue. The formula was created by a Singapore-based\npharmaceutical company. It manufactures the cream for us in its manufacturing facility. We are responsible for branding, marketing and\nsales of the cream. We have launched the product in Singapore through a direct-to-consumer sales channel on our own website as well as\nShopee, an online shopping platform, as well as through various gyms acting as our distributors in the fourth quarter of 2023.\n\n \n\n*Activ\nLabs Cool Relief Muscle Patch*\n\n \n\nActiv\nLabs Cool Relief Muscle Patch is designed to provide temporary relief for aches and pains associated with joint paint, ankle sprains,\nligament sprains, backaches and muscle pain.\n\n \n\nThe\nmuscle patch contains various ingredients, including menthol, sodium hyaluronate, glucosamine, and chondroitin, which work synergistically\nto reduce swelling, relieve pain, and cool the affected area. Our muscle patch is considered under the category of “medicated oils,\nbalms, and medicated plasters” by the HSA. These products do not require approvals or licensing from HSA for their importation,\nmanufacture and sales.\n\n \n\nThe\nmuscle patch is developed in conjunction with an OEM based in mainland China specializing in producing medical and non-medical external\npreparations, which creates the formula for and manufactures the products. We oversee the branding, marketing and sales of the muscle\npatch. We have launched the product in Singapore through a direct-to-consumer sales channel on our own website, as well as through various\ngyms acting as our distributors.\n\n \n\n**Our\nFuture Cosmeceutical Product Candidates**\n\n \n\nWe\nwill explore a number of cosmeceutical product candidates incorporating bullfrog collagen once our novel collagen production technology\nis fully-developed. Products we will consider include, among others, cosmetic scar repair hydrogel and other collagen skincare\nand cosmetic products, for sale directly to both consumers and/or distributors as end products, as well as to cosmetic companies as formulating\ningredients.\n\n \n\nAs\nof the date of this Annual Report, no substantive R&D work on these product candidates had commenced. Subject to the\nprogress of the future R&D work, our goal is to convert these candidates into pipeline products and make them commercially available\nin batches from 2026 to 2027.\n\n \n\n**Overseas\nCollaborations**\n\n \n\nTo\nachieve our strategic objectives, we have entered into various collaboration agreements with local partners in Saudi Arabia, Hong Kong\nand mainland China.\n\n \n\nIn\nSaudi Arabia, we have entered into a joint venture agreement with a local medical services company in May 2022, and are currently in\nthe process of registering our maggot-based chronic wound care products with the SFDA. As of the date of this Annual Report, we had subscribed\nto the ordinary shares in the JV company for cash payable in the amount of Saudi Riyal 406,700 (approximately S$147,000) to support the\nworking capital of the JV company and had made full contributions of Saudi Riyal 406,700 (approximately S$147,000) towards our collaboration\nwith New Future Medical Services Company. We do not have any future payment obligations, and the future revenue generated from the JV\ncompany will be divided based on the percentage of equity held by the shareholders of the JV company. As of the date of this Annual Report,\nwe held a 49% interest in the JV company. The material terms of the agreement are set out below:  \n\n \n\n**Parties**\n \n\ni.\nCuprina Pte. Ltd.\n\n \n\nii.\nNew Future Medical Services Company\n\n \n \n \n\n**Primary\nobjectives**\n \n\nTo\nincorporate a joint venture entity in Saudi Arabia, the principal objectives of which will\nbe:\n\n \n\ni.\nthe establishment of an insectary and laboratory to manufacture our maggot-based chronic wound care products in Saudi Arabia;\n\n \n\nii.\nthe distribution and sale of such products in the Middle East and North Africa, or the relevant territories; and\n\n \n\niii.\nthe incorporation of one or more subsidiaries, or the appointment of third-party distributors within the relevant territories to\nachieve better market penetration.\n\n \n\n44\n\n \n\n \n\n**Our\nprimary responsibilities**\n\n \n\n \n\ni.\nLicensing of rights, including intellectual property rights, to the products for the JV company\nto exploit within the relevant territories;\n\n \n\nii.\noverseeing the design, set-up, operation and management of the insectary and laboratory to be set up in Saudi Arabia;\n\n \n\niii.\nproviding all required information and documents to facilitate all required registrations of the Product within the relevant territories;\n\n \n\niv.\ntraining of local staff in the sale and distribution of the products within the relevant territories; and\n\n \n\nv.\ngranting the JV company the right of first refusal to future new products and technology developed by us on terms and conditions\nto be agreed.\n\n \n \n \n\n**New\nFuture Medical Services Company’s primary responsibilities**\n \n\ni.\nPreparing a comprehensive business plan for the JV company;\n\n \n\nii.\nidentifying and proposing viable options for locating the insectary and laboratory for manufacturing the products in Saudi Arabia;\n\n \n\niii.\noverseeing all sales and distribution activities of the JV company within the relevant territories;\n\n \n\niv.\noverseeing, managing and ensuring all required medical device registrations of the products with the SFDA and all other regulatory\nagencies within the relevant territories;\n\n \n \n \n\n**Term\nand termination**\n \n\nwith\nrespect to any one shareholder of the JV company when:\n\n \n\ni.\nsuch shareholder ceases to be a member of the JV company in accordance with the provisions of this agreement. If, following any such\ntransfer by one shareholder, there remains more than one shareholder bound by the provisions of this agreement, then this agreement\nshall continue in full force and effect as between the continuing shareholders;\n\n \n\nii.\na bankruptcy or winding-up order is made against such shareholder; or\n\n \n\niii.\nthe JV company’s shares become listed and are thereby freely transferable or tradable on a recognized stock exchange.\n\n \n\nIn\nHong Kong, we have collaborated with Advanced Biotech and Engineering Limited and signed an exclusive distribution and cooperation and\nprofit-sharing agreement for our MEDIFLY products, which became effective in June 2023, the material terms of which are set out below:  \n\n \n\n**Parties**\n \n\ni.\nCuprina Pte. Ltd.\n\n \n\nii.\nAdvanced Biotech and Engineering Limited, or Advanced Biotech\n\n \n \n \n\n**Primary\nobjective**\n \nWe\ngranted Advanced Biotech a sole and exclusive, non-transferable, non-sub-licensable, non-assignable, license to develop, market,\npromote, sell, and deliver the MEDIFLY products within Hong Kong on an exclusive basis.\n\n \n \n \n\n**Our\nprimary responsibilities**\n\n \n\n \n\ni.\nprovide the MEDIFLY products manufactured by us to Advanced Biotech at the designated destination\nof Advanced Biotech in proper packaging to ensure the quality of such products upon delivery\nto Advanced Biotech;\n\n \n\nii.\nprovide literature and merchandising aids, including promotional materials to enable Advanced Biotech to distribute to potential\ncustomers;\n\n \n\niii.\nany and all liabilities claims against the products shall remain with us;\n\n \n\niv.\nwe will not appoint any other distributor(s) to sell MEDIFLY products in Hong Kong.\n\n \n\n45\n\n \n\n \n\n**Advanced\nBiotech and Engineering Limited’s primary responsibilities**\n \n\ni.\nProvide support and advice on promoting, selling or marketing and develop with its specialty\nknow-how, the Products and distribute new and updated technical and sales literature to customers\nas provided by us;\n\n \n\nii.\nuse commercially reasonable efforts to develop, promote, market and sell the Products within Hong Kong and shall convene related\nactivities to promote the Products twice every two years;\n\n \n\niii.\nprovide quarterly sales information to us; and\n\n \n\niv.\nobtain on behalf of and for the benefit of either or both parties to the agreement including all licenses necessary in Hong Kong\nto carry on the manufacture and sale of the Products;\n\n \n\n**Payment\nand profit sharing**\n \n\nThe\nparties to the agreement will share in the gross profits derived from the sales of the products\non a 50/50 basis; and\n\n \n\n**Term\nand termination**\n \nThe\nagreement shall last for five years from the date of execution and thereafter automatically renew until terminated by one hundred\nand eighty (180) days’ prior written notice by either party to the agreement.\n\n \n\nIn\nmainland China, we have collaborated with Nan’ao (Beijing) Hospital Management Co., Ltd., for the purpose of registering our maggot-based\nchronic wound care products with the NMPA. To this end, we have entered into an Agreement to Collaborate and Protect Confidentiality\nin August 2022, and the material terms of which are set out below:    \n\n \n\n**Parties**\n \n\ni.\nCuprina Pte. Ltd.\n\n \n\nii.\nNan’ao (Beijing) Hospital Management Co., Ltd. or Nan’ao\n\n \n \n \n\n**Primary\nobjectives**\n \nRegistration\nof our maggot-based chronic wound care products with the NMPA\n\n \n \n \n\n**Arrangement\nbetween parties**\n\n \n\n \n\ni.\nWe authorize Nan’ao to fully represent us to engage Shanghai Zhangjiang Yidiantong\nTechnology Co., Ltd., or Yidiantong, to perform services relating to the classification and\ndefinition of our maggot-based chronic wound care products in the registration of technical\nservices for medical device products and other related technical services;\n\n \n\nii.\nwe shall provide Nan’ao with product-related information as required by the NMPA or other relevant legal authorities, and entrust\nYidiantong to provide all services required to register our products to be registered as medical device by the NMPA or other relevant\nlegal authorities; and\n\n \n\niii.\nwe entrust Nan’ao to be responsible for the management and liaison with Yidiantong to apply for classification and determination\nto the NMPA on whether our maggot-based chronic wound care product is a medical device, and what types of medical devices belong\nto it, and to track the progress of the application. Yidiantong shall convey all queries given by the NMPA to us and Nan’ao,\nwhich in turn shall endeavor to answer and if necessary, submit supplementary materials in accordance with the prescribed format\nuntil the final classification definition notice is obtained. If the NMPA determines that the product needs to hold an expert discussion\nmeeting, Yidiantong will assume the responsibility to provide expert meeting coordination and meeting materials.\n\n \n \n \n\n**Fee**\n \n\nThe\ntotal service fee payable to Nan’ao is RMB50,000.\n\n \n\nThe\nservice fee payable to Yidiantong will be negotiated separately between Yidiantong and us.\n\n \n\n46\n\n \n\n \n\n**Our\nNew Business Collaborations**\n\n \n\nIn\nconnection with our IVF media production business, we have collaborated with Ferti-Craft Pte Ltd. (“Ferti-Craft”), a Singapore-based\nmedtech company specializing in human Assisted Reproductive Technology, for the purpose of establishing an ISO 13485-certified facility\nto manufacture IVF media products and achieve HSA medical device registration approval. To this end, we have entered into an ISO 13485\nFacility Setup and Regulatory Compliance Agreement in November 2024 (further amended in December 2025), the material terms of which are set out below:\n\n \n\n**Parties**\n \n\ni.\nCuprina Pte. Ltd.\n\n \n\nii.\nFerti-Craft Pte Ltd.\n\n \n \n \n\n**Primary\nobjectives**\n \nSetup\nand operation of an ISO 13485-certified facility by Cuprina Pte. Ltd. to manufacture IVF media product SKUs specified by Ferti-Craft,\nand achievement of HSA medical device registration approval for those products\n\n \n \n \n\n**Arrangement\nbetween parties**\n \n\ni.\nCuprina Pte. Ltd. shall set up and operate a facility meeting ISO 13485 standards at its\nprincipal location, obtain ISO 13485 certification, and use its best efforts to achieve HSA\nregistration for the agreed IVF media product SKUs. Cuprina Pte. Ltd. will provide all necessary\nregulatory expertise, equipment, and infrastructure for the facility, and shall provide Ferti-Craft\nwith progress reports on milestones and deliverables;\n\n \n\n \n \n\nii.\nFerti-Craft shall provide detailed product specifications and guidance on the product SKUs,\ncontribute all intellectual property, subject matter expertise, and production know-how in\nrespect of the products, and shall provide all necessary documentation and testing certificates\nrequired by HSA promptly and diligently. Ferti-Craft shall also be responsible for all marketing,\nsales promotions, and customer relations; and\n\n \n\n \n \n\niii.\nCuprina Pte. Ltd. shall act as the contract manufacturer and hold the product registration on behalf of Ferti-Craft. Upon successful\nHSA registration, the registrations shall be transferred to Ferti-Craft once Ferti-Craft obtains all necessary certifications and licenses\nto hold the product registration, with the cost of such transfer to be borne by Ferti-Craft.\n\n \n \n \n\n**Fee**\n \n\ni.\nDuring the period prior to receiving regulatory approval from HSA, Ferti-Craft shall remit\na fixed monthly fee to Cuprina Pte. Ltd. to cover administrative, rental, and operational\ncosts. Upon receipt of regulatory approval, the monthly fee shall be adjusted accordingly\nto reflect the transition into full operational readiness;\n\n \n\n \n \n\nii.\nin addition to the monthly fee, Ferti-Craft shall remit to Cuprina Pte. Ltd. a portion of revenue\ngenerated from domestic sales within Singapore and exports conducted via the Singapore facility,\ncalculated and disbursed on a quarterly basis; and\n\n \n\n \n \niii.\nall regulatory costs charged by HSA in connection with the registration and approval of the product SKUs, as well as all costs associated\nwith the import and export of equipment or products, shall be borne by Ferti-Craft. All costs associated with obtaining and maintaining\nISO 13485 certification shall be borne by Cuprina Pte. Ltd..\n\n \n \n \n\n**Term**\n \nThe\nagreement shall remain in effect until all deliverables have been completed and certifications obtained, unless terminated earlier\nin accordance with the agreement. Either party may terminate for cause with thirty (30) days’ written notice upon material\nbreach, or for convenience with sixty (60) days’ written notice, subject to a safety period linked to specific project milestones\nduring which unilateral termination for convenience is not permitted.\n\n \n \n \n\n**Governing\nlaw**\n \nLaws\nof Singapore, with disputes to be resolved first through good faith negotiation, then mediation administered by the Singapore Mediation\nCentre, and if unresolved, by arbitration administered by the Singapore International Arbitration Centre (“SIAC”).\n\n \n\n47\n\n \n\n \n\nIn\nconnection with our medical waste recycling business, we have collaborated with Zhejiang Heliang Technology Co., Ltd. (“Zhejiang\nHeliang”), for the purpose of securing exclusive licensing rights to deploy a medical waste recycling technology in Singapore and\nacross Southeast Asia. To this end, we have entered into an Exclusive License Agreement in August 2025, the material terms of which are\nset out below:\n\n \n\n**Parties**\n \n\ni.\nCuprina Pte. Ltd.\n\n \n\nii.\nZhejiang Heliang Technology Co., Ltd.\n\n \n \n \n\n**Primary\nobjectives**\n \nExclusive\nlicensing and commercialization of Zhejiang Heliang’s medical waste recycling technology in Singapore, with a right of first\nrefusal to expand into ten additional Southeast Asian countries\n\n \n \n \n\n**Arrangement\nbetween parties**\n \n\ni.\nZhejiang Heliang grants Cuprina Pte. Ltd. exclusive rights to use, implement, and commercialize\nits medical waste recycling technology within Singapore for the duration of the agreement,\nincluding all necessary licenses and know-how required to establish and operate medical waste\nrecycling facilities;\n\n \n\n \n \n\nii.\nZhejiang Heliang shall provide Cuprina Pte. Ltd. with the complete manufacturing process\nfor recycling medical waste, fully documented with detailed technical information, and shall\nensure compliance with Best Available Techniques (“BAT”) and Best Environmental\nPractices (“BEP”) guidelines in the manufacturing process, together with a comprehensive\nequipment list including specifications and supplier information necessary for the establishment\nand operation of the recycling facilities;\n\n \n\n \n \n\niii.\nZhejiang Heliang shall provide technical support and training to Cuprina Pte. Ltd.’s\npersonnel to ensure the successful implementation and operation of the technology, including\ninitial setup assistance, ongoing support as reasonably requested, and the availability of\nqualified personnel to provide technical services within 48 hours of a support request; and\n\n \n\n \n \niv.\nupon Zhejiang Heliang’s reasonable determination of successful implementation and commercialization in Singapore, Cuprina Pte.\nLtd. shall have the right of first refusal to expand the use, implementation, and commercialization of the licensed technology into\nother Southeast Asian markets within the region, including Brunei, Myanmar, Cambodia, Timor-Leste, Indonesia, Laos, Malaysia, the\nPhilippines, Thailand, and Vietnam, subject to mutually agreeable terms.\n\n \n \n \n\n**Fee**\n \nCuprina\nPte. Ltd. shall pay Zhejiang Heliang ongoing royalties of 12.5% of the net sales generated from the use of the licensed medical waste\nrecycling technology, calculated quarterly and payable within 30 days following the end of each calendar quarter.\n\n \n \n \n\n**Term**\n \nThe\nagreement is effective from the date of signing and shall continue for a period of 3 years, with automatic renewals for successive\n3-year periods unless either party is unable to fulfill the scope of its roles.\n\n \n\n**Research\nand Development**\n\n \n\nAs\nof December 31, 2025, we had two team members responsible for our R&D work who work collaboratively to develop\ninnovative solutions in various aspects of our wound care market. Our R&D team comprises members who hold degrees in relevant fields,\nincluding biotechnology, pharmaceutical sciences, biomedical engineering, entomology and product design engineering.\n\n \n\n48\n\n \n\n \n\nThe\nteam follows a well-defined workflow that is detailed below.\n\n \n\n**Ideation**\n\n \n\n \nIdeation\nbegins with identifying a sustainable in-house capability to generate a raw material or the potential to utilize waste material as\na side stream, which will become the foundation to generate a novel medical device. Ideation typically takes approximately one month\nto complete.\n\n \n \n \n\n**Literature\nReview**\n\n \n\n \nIn\nthe context of medical device product development, the literature review involves an exploration of existing scientific research,\nmedical literature, industry guidelines, and regulatory standards relevant to the proposed medical device. This step helps the development\nteam understand the medical landscape, existing technologies, clinical practices, and safety considerations associated with the specific\nmedical domain the device aims to address. Literature review typically takes approximately one month to complete.\n\n \n \n \n\n**Preliminary\nInvestigation**\n\n \n\n \nPreliminary\ninvestigation in medical device development focuses on initial research to assess the feasibility and potential impact of the proposed\nmedical device. This phase involves investigating factors such as the clinical need, patient population, potential competitors, regulatory\nrequirements, and potential risks associated with the device’s use. The aim is to establish the viability of the device concept\nbefore proceeding further. Preliminary investigation typically takes approximately one month to complete.\n\n \n \n \n\n**Process\nInvestigation**\n\n \n\n \nProcess\ninvestigation in medical device development involves a thorough examination of the technical and operational aspects required to\ndesign and manufacture the device. This includes determining the materials, manufacturing processes, sterilization methods, and quality\ncontrol procedures necessary to ensure the device’s safety, efficacy, and compliance with medical standards. Process investigation\ntypically takes around one month to complete.\n\n \n \n \n\n**Prototyping**\n\n \n\n \nPrototyping\nin the medical device context entails creating a functional prototype of the device. This prototype is used for testing and validation\npurposes, enabling the development team to identify potential design flaws, usability issues, and other concerns. It also aids in\ncommunicating the device’s concept to stakeholders, including medical professionals, clinical studies review boards and potential\ninvestors. Prototyping typically takes between one and three months to complete. However, the specific duration required for this\nstep depends heavily on the nature of the product being developed.\n\n \n \n \n\n**Process\nReview**\n\n \n\n \nProcess\nreview involves evaluating the outcomes of the prototyping phase and refining the design and manufacturing processes accordingly.\nThis iterative process ensures that the device’s design aligns with its intended medical application and that any technical\nchallenges are addressed before proceeding to the next stages. Process review typically takes approximately three months to complete.\n\n \n \n \n\n**Process\nOptimization**\n\n \n\n \nProcess\noptimization focuses on refining the manufacturing processes to ensure consistent quality, reproducibility, and cost-effectiveness.\nIn medical device development, this may involve optimizing production workflows, materials sourcing, and quality assurance procedures\nto meet regulatory standards while maintaining efficiency and functionality. Process optimization typically takes approximately three\nmonths to complete. However, the specific duration required for this step depends heavily on the nature of the product being developed.\n\n \n\n49\n\n \n\n \n\n**Documentation\nfor Regulatory Standards**\n\n \n\n \nGiven\nthe stringent regulatory requirements in the medical device industry, thorough documentation is essential. This includes creating\ndesign documentation, risk assessments, clinical evaluation reports, and other essential documentation necessary to demonstrate the\ndevice’s safety, performance, and compliance with applicable regulations. Documentation for regulatory standards typically\ntakes approximately six months to complete.\n\n \n \n \n\n**Production\nValidation**\n\n \n\n \nProduction\nvalidation involves testing and validating the manufacturing processes to ensure that the medical devices produced consistently meet\nquality and performance specifications. This step ensures that the devices manufactured in larger quantities maintain the same level\nof quality as the prototypes. This step also ensure that the production process meet CGMP/ current good laboratory practices, or\nCGLP standards for international compliance. Production validation typically takes approximately one month to complete.\n\n \n \n \n\n**Regulatory\nApproval**\n\n \n\n \nRegulatory\napproval is a critical phase in medical device development. It involves preparing and submitting samples for biocompatibility tests\nand then documentation requirements satisfy regulatory authorities (such as the FDA, HSA, etc.) review and approval. The documentation\ndemonstrates the device’s safety and effectiveness, as well as its compliance with applicable regulations and standards. Regulatory\napproval typically takes between three and six months to complete. However, the exact duration for this step heavily depends on the\nnature of the product under development and the specific jurisdiction in which approval is sought.\n\n \n \n \n\n**Commercialization**\n \nCommercialization\nin medical device development entails the strategic planning and execution of activities to introduce the device to the market. This\nincludes a clinical review/trial process, developing marketing strategies, establishing distribution channels, setting pricing, training\nmedical professionals on device use, and ensuring post-market surveillance to monitor the device’s performance and safety.\nCommercialization typically takes between six and eight months to complete. However, the duration may vary depending on factors such\nas the number of locations involved and the size of the patient population for the clinical study.\n\n \n\nIn\naddition to in-house R&D efforts, we believe that it is imperative to accelerate our R&D advancement through collaborative research\nwith institutes of higher learning, government agencies and/or third-party companies that have adjunct technology for use. Leveraging\nthe technological expertise of external research partners keeps us nimble, objective driven and allows us to work on multiple products\nsimultaneously. It also gives us the ability to utilize and commercialize innovative intellectual properties developed by these research\npartners in our products through arrangements such as technology licensing agreements and joint research collaboration.\nIn particular, we have worked closely with NTU and Aiodine Laboratory Pte. Ltd. for the development of our pipeline products.\n\n \n\n*Licensing\nAgreement with NTU*  \n\n \n\nOn\nJune 3, 2022, we entered into a licensing agreement with NTU, pursuant to which NTU agreed to grant us an exclusive license to develop,\nmake, have made, import into, export from, offer for sale, sell and have sold products developed incorporating licensed technology primarily\nincluding a utility patent application relating to bullfrog skin-derived collagen and its use as a wound dressing material (together\nwith any future divisional, continuation or reissue applications of such patent application, and all patents issuing from the application,\nthe “Licensed Patents”) and unpublished R&D information, technical information, manufacturing technology, formulae, data,\nprotocols, designs and other information in relation to bullfrog skin-derived collagen and its use as a wound dressing material (the\n“Licensed Proprietary Materials”). The license rights will terminate on a country-by-country basis upon the last to expire\nof any patents under the Licensed Patents or the end of a period of 20 years from the date of the first commercial sale of Licensed Products\n(as defined below). We undertook and agreed with NTU that we would procure a first commercial sale of a Licensed Product within three\nyears of the signing date of the agreement. Pursuant to the terms of the agreement, we are required to make milestone payments to NTU\nin the following amounts: (i) S$25,000 upon signing the agreement, (ii) S$15,000 on the first anniversary of the signing date, and (iii)\nS$15,000 on the second anniversary of the signing date. As of the date of this Annual Report, all of these payments have been made according\nto schedule and we have made aggregate payments of S$55,000 to NTU under the agreement. In addition to the milestone payments,\nwe will pay to NTU royalties in respect of all sales, leases or other transfers of licensed products during the term of the agreement\nat the following rates: (i) 3.5% of net sales of any product or service the making, using, selling or import of which is covered by any\nclaim of any patent under the Licensed Patents (the “Patented Licensed Products”); and (ii) 2.5% of net sales of any product\nor service, other than Patented Licensed Products, that incorporates or that is or was developed in whole or in part through the use\nor application of any of the Licensed Proprietary Materials (the “Other Licensed Products”, together with the Patented Licensed\nProducts, the “Licensed Products”).\n\n \n\n50\n\n \n\n \n\nIf\nthe annual royalty payments fall below S$15,000, the Licensee will compensate NTU with additional royalties to reach the minimum sum\nof S$15,000 per year. This requirement will be effective three years from the signing date and throughout the term of the agreement.\nAs of the date of this Annual Report, NTU can terminate the agreement by written notice if (i) we breach a material term, including non-payment\nor failure to meet performance milestones; (ii) we assert intellectual property rights against NTU; (iii) we cease or announce the intention\nto cease our business; (iv) we become insolvent, unable to pay debts, or enter into arrangements with creditors; (v) we go into liquidation,\nexcept for bona fide reconstruction or amalgamation; or (vi) we have a receiver or judicial manager appointed. We may terminate the agreement\nwith a written notice of ninety (90) days in advance to NTU.\n\n \n\n*Novel\nCollagen Production Process*\n\n \n\nWe\nhave an exclusive license for process technology developed by NTU for scale-up and commercial production of bullfrog collagen for our\nplanned bullfrog collagen wound care products. Such license encompasses the extraction, purification, and concentration of the collagen\nat scale.\n\n \n\nWe\nintend that this process will be compliant with FDA 510(K) standards and follow CGMP regulations. Additionally, the manufacturing process\nwill be carried out in an ISO 7 (Class 10,000) cleanroom to ensure satisfactory quality standards. Furthermore, the process has shown\nhigher extraction yield and requires less extraction time, making it more efficient and sustainable.\n\n \n\nBelow\nis a chart showing the steps required for producing bullfrog collagen using the process mentioned above:\n\n \n\n* *\n\n*Industry\nResearch Collaboration Agreement with NTU*\n\n \n\nOn\nAugust 22, 2022, we entered into an industry research collaboration agreement with NTU, pursuant to which both parties agreed to jointly\nundertake a research project regarding the development and validation of American bullfrog (*Lithobates catesbeianus*) skin waste\nto generate collagen-based wound products, or the Joint Research Project. The scope of the collaboration includes biomaterial (bullfrog\ncollagen sponge dressings/hydrogels) development, biomaterial characterization (in vitro degradation, mechanical properties, ultrastructure,\nself-healing properties), in vitro cell studies (cytocompatibility, cell adhesion, immunogenicity, wound healing assays) and in vivo\nanimal studies (functional wound healing assessment in diabetic rats).\n\n \n\nThe\nterm of the agreement will continue for 18 months and may be extended by mutual agreement. The term of the agreement has subsequently\nbeen extended for another twelve months upon the expiry of the original term of 18 months by the parties to the agreement. The deliverables\nof the Joint Research Project include optimized processing parameters for bullfrog collagen sponge dressings and hydrogels wound healing\nplatforms, in vitro data to evaluate biocompatibility of the developed wound healing products, and preclinical in vivo data to evaluate\nfunctional performance of the wound healing products, the latter two deliverables will be provided solely by NTU. As of the date of the\nreport, the Joint Research Project has achieved several milestones in the development of bullfrog collagen-based chronic wound care products.\nThese milestones include the extraction and detailed characterization of bullfrog collagen, as well as the processing and characterization\nof the bullfrog collagen sponge. Furthermore, in vivo studies and analyses have been conducted on the bullfrog collagen sponge. The remaining\nmaterial phases of the Joint Research Project involve the processing and characterization of the bullfrog collagen hydrogel, followed\nby in vitro studies on the hydrogel. Subsequently, the Joint Research Project will proceed with further in vivo studies to assess the\neffectiveness and potential applications of both the bullfrog collagen sponge and hydrogel.\n\n \n\n51\n\n \n\n \n\nIntellectual\nproperty that is first generated, conceived, produced, developed or reduced to practice in the course of performing the Joint Research\nProject, or Foreground IP, and is created or developed solely by one party to the agreement without any inventive contribution from the\nother party, will be the sole and exclusive property of the inventing party. All Foreground IP created or developed jointly by NTU and\nus, or Joint IP, will be jointly owned in equal undivided shares by both parties. The commercialization of the Joint IP will be governed\nby a separate written agreement to be entered into at a later date. As of the date of this Annual Report, we have not entered into such\ncommercialization agreement.\n\n \n\nWe\nwill contribute the funding of the Joint Research Project, while NTU will provide in-kind contributions primarily including research\nequipment and manpower. In particular, our funding includes approximately S$333,450 for: (i) a postdoctoral fellow leading biomaterials\ndevelopment and evaluation; (ii) general lab consumables and specific items needed for various tests; (iii) other miscellaneous items\nincluding equipment maintenance, core facility charges, transportation and publication costs; and (iv) a 30% overhead charge on the total\ndirect project cost. As of the date of this Annual Report, we had settled 100% of our contributions under this agreement.\n\n \n\nThe\nagreement can be terminated by written consent of either party to the agreement under the following circumstances: (i) material breach\nby the terminated party, either incapable of rectification or not rectified within thirty (30) days of notice; (ii) engagement in activities\nthat may expose NTU to sanctions, prohibitions, restrictions, laws, or regulations; (iii) non-approval or revocation of approval by the\nrelevant institutional review board for the Joint Research Project; (iv) termination or revocation of any grant provided for the Joint\nResearch Project; or (v) events such as the appointment of a receiver, liquidation, inability to pay debts, or cessation of business\nby the terminated party, as permitted by law. In addition, either party can withdraw from the agreement by providing thirty (30) days’\nprior written notice, resulting in effective termination at the end of the notice period for that party.\n\n* *\n\n*Joint\nVenture Agreement with Aiodine Laboratory Pte. Ltd.*\n\n \n\nOn\nNovember 18, 2025, we entered into a joint venture agreement with Aiodine Laboratory Pte. Ltd, a company incorporated in Singapore, pursuant\nto which the parties agreed to incorporate a joint venture company in Singapore for the worldwide distribution, marketing, and commercialization\nof Aiodine’s proprietary iodine-based wound care and topical antiseptic products.\n\n \n\nWe\nhold 125,250 ordinary shares, representing a 50.1% equity interest, and Aiodine holds 124,750 ordinary shares, representing a 49.9% equity\ninterest, in the joint venture company. The initial issued share capital of the joint venture company is SGD 250,000, comprising 250,000\nordinary shares of SGD 1.00 each.\n\n \n\nUnder\nthe terms of the agreement, Aiodine has granted the joint venture company a worldwide exclusive licence to distribute, market, and commercialize\nthe products for the duration of the agreement, in consideration of an upfront license fee of SGD 50,000 payable by us to the shareholders\nof Aiodine upon execution of the agreement. The joint venture company will pay Aiodine an annual royalty equal to 3% of net sales of\nthe products, commencing in the first financial year in which the joint venture company reports a net profit, and applying for each subsequent\nprofitable financial year thereafter. Aiodine is responsible for the manufacture and supply of the products to the joint venture company\non a cost-plus basis, as well as providing all necessary technical expertise, know-how, and intellectual property related to the products,\nincluding formulations, manufacturing processes, and technical support for product development and regulatory compliance. Cuprina is\nresponsible for preparing a comprehensive business plan for the joint venture company, overseeing all sales and distribution activities\nworldwide, identifying and managing relationships with distributors, and the day-to-day management of the joint venture company.\n\n \n\nThe\nboard of directors of the joint venture company comprises of four directors, with Aiodine and Cuprina each entitled to appoint two nominees.\nThe Chairman of the board of directors shall rotate every two years between Aiodine and Cuprina nominees, with the initial Chairman being\nour Chief Executive Officer, Mr. David Quek Yong Qi. Neither party shall take any shareholder action that materially affects the business,\nintellectual property, or strategic direction of the joint venture company without the affirmative vote of both parties.\n\n \n\nNeither\nparty shall transfer, assign, or otherwise dispose of its shares in the joint venture company during the first five years from the date\nof the agreement, and for a further period of five years thereafter, except with the prior written consent of the other party.\n\n \n\n52\n\n \n\n \n\nThe\nagreement may be terminated with respect to any shareholder upon: (i) such shareholder ceasing to be a member of the joint venture company\nin accordance with the provisions of the agreement; (ii) a bankruptcy or winding-up order being made against such shareholder; or (iii)\nthe joint venture company’s shares becoming listed and freely transferable on a recognized stock exchange. In addition, a non-defaulting\nshareholder may serve a default notice and require compulsory transfer of shares upon: (i) material breach of the agreement not remedied\nwithin thirty days of notice; (ii) insolvency or appointment of a receiver over the defaulting shareholder; or (iii) breach of the non-competition\nor non-disclosure provisions of the agreement. Any disputes arising out of the agreement shall be referred first to mediation at the\nSingapore Mediation Centre, and if unresolved, to arbitration in Singapore in accordance with the rules of the Singapore International\nArbitration Centre.\n\n \n\n**Sales\nand Marketing**\n\n \n\nAs\nof December 31, 2025, our sales and marketing team consisted of two country managers and one business development lead, all of whom are\nlocated in Singapore. The country managers, in collaboration with the business development lead, are responsible for overseeing all sales\nand marketing activities within their respective designated territories including (i) Singapore, (ii) Hong Kong and mainland China, (iii)\nSouth East Asia (excluding Singapore and (iv) Saudi Arabia, respectively, and customer segments, while our business development lead\nis primarily responsible for overseeing all pipeline activities, identifying potential customers, and developing and executing strategic\nplans aimed at driving revenue growth and expanding our customer base.\n\n \n\nThe\nsales of our commercialized chronic wound care products are managed through a combination of direct sales force and distributors, depending\non the geographic markets where our products are sold. In Singapore, our country managers, acting as sales representative, work closely\nwith local physicians in a diverse array of public and private hospitals to demonstrate our chronic wound care products in their respective\ncare settings and provide comprehensive support throughout the sales process such as providing post-marketing surveys and product evaluation\nforms and maintaining 24/7 hotline for clinical support. In Hong Kong, we rely on our local partner, to whom we have granted exclusive\nrights, to distribute our maggot-based chronic wound care products.\n\n \n\nFor\nour cosmeceutical products, the sales of MEND Skin Restoration Balm are managed through our collaborative venture with Full Crimp Milk,\nwhich assumes the responsibility for sales efforts. Its sales efforts encompass two main aspects, namely, business-to-business and business-to-consumer,\nwhich include both identifying gyms in Singapore and other countries to establish them as authorized distributors for the product, as\nwell as operating its Shopee platform and its own dedicated Full Crimp Milk website to facilitate direct-to-consumer sales. For ENDURE\nMuscle Energy Cream and Activ Labs Cool Relief Muscle Patch, we adopted a similar approach by both offering them through gyms as authorized\ndistributors, as well as on our own website and Shopee platform.\n\n \n\nOur\ncurrent marketing strategy for the commercialized chronic wound care product primarily employs the following measures:\n\n \n\n \n●\nactively\nengage with physicians through education and training events, conferences, and collaborations on research projects and clinical trials;\n\n \n \n \n\n \n●\nenhancing\nour online presence through website optimization, social media platforms, and targeted online advertising to promote our brand and\nproducts.\n\n \n \n \n\n \n●\nparticipating\nin prominent wound conferences, engaging in booths and tradeshows, and seizing opportunities for direct engagement with healthcare\nprofessionals and industry experts.\n\n \n \n \n\n \n●\nKey\nOpinion Leader (KOL) engagement and management is a significant aspect of our marketing efforts. We collaborate with influential\nclinicians who inspire confidence, provide invaluable insights, and promote our therapies and products. This approach is particularly\nimportant given the nature of our therapies, which often require the endorsement of respected doctors and clinicians.\n\n \n\n53\n\n \n\n \n\nFor\nMEND Skin Restoration Balm, Full Crimp Milk is responsible for the marketing of the product and primarily employs the following measures:\n\n \n\n \n●\nManaging\nthe Full Crimp Milk website and its social media platform through the development of various marketing collaterals such as posters,\neducational flyers, and visually appealing images specifically designed for promotion\n\n \n \n \n\n \n●\nCreating\nand maintaining the dedicated MEND Skin Restoration Balm website to raise product awareness and provide product and sales information\nto potential customers.\n\n \n \n \n\n \n●\nActively\nparticipating in gym booths and events to facilitate direct promotion of the product and engage with potential customers.\n\n \n \n \n\n \n●\nIdentifying\nand managing potential KOLs who can effectively endorse and advocate for the product.\n\n \n\nWe\noversee the branding and marketing strategy for ENDURE Muscle Energy Cream and Activ Labs Cool Relief Muscle Patch. We list these products\non our website to raise awareness and provide potential customers with product information and sales details. In addition, we promote\nour products through gyms to reach our target demographics more directly and effectively.\n\n \n\n**Pricing\nPolicy**\n\n \n\nOur\ncurrent commercialized chronic wound care product includes the maggot-based products. Our pricing policy for such product line varies\nbased on the specific market that we operate and/or the agreements into which we entered with our local partners.  \n\n \n\n \n●\nIn\nSingapore, we have adopted a pricing strategy that combines elements of both penetration pricing and bundling pricing models. By\ninitially setting our prices lower, we aim to capture a significant market share and foster widespread adoption. We offer a variety\nof purchase options for patients of different treatment needs, including sale by single vial and unlimited vials within a subscribed\nperiod of time, such as by week and by month.\n\n \n \n \n\n \n●\nIn\nHong Kong, prices of our maggot-based products are determined based on the consultation with our exclusive local partner who has\nextensive knowledge of the Hong Kong wound care market.\n\n \n\nWe\nadjust the prices of our maggot-based products periodically based on local market conditions, cost fluctuations and other relevant factors\nto ensure that they remain competitive and are aligned with relevant industry standards. The pricing models of other wound care products\nunder development have not been determined.\n\n \n\nOur\ncurrent commercialized cosmeceutical products are priced using a “cost-plus” strategy, which is assessed against competitor\nprices to ensure that our products are attractively priced for our target customers. We consolidate all relevant costs associated with\neach unit of the products and apply a markup percentage to arrive at a final selling price. We conduct market research to ensure that\nour final selling price is aligned with that of our competitors. To incentivize larger volume orders and foster mutually beneficial relationships\nwith our distributors, we offer a tiered pricing structure for our current commercialized products, offering price per unit discounts\nfor purchases of higher quantities by any individual gym.\n\n \n\n**Major\nCustomers**\n\n \n\nOur\ncustomers primarily include major public and private hospitals and clinics in Singapore. We do not enter into long-term written\nsales agreements with our customers and conduct sales on a case-by-case basis. The terms of our sales are communicated through messaging\napplications such as WhatsApp. The key terms (including those with our top customers) include, among others:\n\n \n\n \n●\nThe\nproduct’s name, type, quantity and price; and\n\n \n \n \n\n \n●\nDelivery\nmethod and payment terms. Delivery is typically made within one day after a purchase order is placed. Payments are typically due\nwithin 30 days after the completion of treatment.\n\n \n\n54\n\n \n\n \n\nFor\nthe years ended December 31, 2024, and 2025, sales to our five largest customers collectively accounted for approximately 71.2% and 65.7%,\nrespectively, of our total revenue, and sales to our largest customer accounted for approximately 23.8% and 28.3%, respectively,\nof our total revenue.\n\n \n\n**Manufacturing**\n\n \n\nWe\nmanufacture internally our MEDIFLY products using our laboratory and use third-party OEM manufacturers for our cosmeceutical products.\n\n \n\nThe\nMEDIFLY products are manufactured on-site in our laboratory in Singapore and is dependent on the availability of sufficient quantities\nof maggots. We breed and collect maggots in our laboratory without relying on any third-party suppliers. Our laboratory consists of an\ninsectary area, where all life stages of the Cuprina blowflies are maintained, and a microbiology area, where the harvested eggs are\ndisinfected and processed to become the MEDIFLY products. In the years ended December 31, 2024 and 2025, and up to the date of this Annual\nReport, we have not encountered any significant disruptions or capacity constraints that have had a material impact on the production\nof maggots or the fulfillment of orders for our MEDIFLY products. Below is the general production procedure used to produce\nmedical grade sterile maggots used by us:\n\n \n\nWe\ncollect colonies of *Lucilia cuprina* flies from the wild and breed them in our specialized insectary area within our laboratory.\nThe flies are fed a diet of essential nutrients until they become sexually active, and females become gravid. Gravid females are stimulated\nto lay eggs on a high protein substrate, which are then separated, rinsed, and sterilized through multiple washes in a buffered disinfection\nsolution. Viable eggs are removed and placed into prepared transportation vials containing a nutrient agar transport media. Quality control\nmeasures are taken to ensure the sterility of the eggs and larvae, which are incubated and inspected. The resulting vials of hatched\nlarvae are labeled and assembled into our final products.\n\n \n\nOur\nproduction of MEDIFLY products is based on projected market demand while accounting for orders already received. Besides maggots, we\nstock inventory of raw materials, components, and finished products at our facility. We typically maintain sufficient stock of key materials\nin inventory to ensure that we have enough materials and finished products to meet customer demand. For example, we maintain vials sufficient\nto cover projected demand for the following 26 weeks of production.\n\n \n\nThe\nproduction of MEDIFLY products at our laboratory is certified to the ISO 13485:2016 standards. To secure the relevant FDA 510(k) clearance,\nwe are working towards compliance with the FDA’s Quality Management System Regulation (QMSR), for the production of both our commercialized\nMEDIFLY products and bullfrog collagen related products currently in the pipeline.\n\n \n\nAs\nwe expand both geographically and in terms of product offerings in the future, we plan to establish similar manufacturing facilities\nin other regions to meet the market demands for our products. To facilitate the future regulatory approval process, we expect all future\nlaboratories will adhere to the relevant CGMP/ISO 13485/QMSR standards.\n\n \n\n**Quality\nControl and Assurance**\n\n \n\nAll\nof our products are directly applied to the human body and are closely related to the life and health of users. Quality and safety are\nalways our core values. Reliable, safe and stable product quality is an important driving factor for maintaining market competitiveness.\nThrough our business dealings with major hospitals and medical institutions across Singapore and other countries, we believe that we\nhave developed a sophisticated quality control management system as well as a strict and effective internal control system in accordance\nwith the requirements of the relevant laws and regulations.\n\n \n\nIn\norder to maintain product safety and a high standard of product quality, we have implemented a strict set of quality control policies\nand inspection protocols. These policies and protocols are enforced by our quality control and assurance specialist within our production\nteam along every step of the production to post-production process. We believe our quality control management system is in line with\ninternational standards.\n\n \n\nOur\ncurrent quality control and assurance procedures are established according to ISO 13485:2016 international standards, which specifies\nrequirements for a Quality Management System, or QMS, to be applied by entities involved in the medical device industry. To ensure the\nrelevance and appropriateness of our QMS system, we undergo yearly audits.\n\n \n\nOur\ncurrent quality control and assurance procedures cover various aspects of our business operations, including sales and processing; product\nproduction and delivery; vendor evaluation; purchasing and verification; resource management; equipment calibration; control of nonconformance,\nanalysis and improvement; risk management; QMS management review; document control; corrective and preventive action; control of quality\nrecords, and internal quality audits.\n\n \n\n55\n\n \n\n \n\nWe\nare currently in the process of updating our QMS systems to comply with FDA 510(k) and FDA’s Quality Management System Regulation\nstandards.  \n\n \n\nDespite\nour quality control management system, we cannot eliminate the risks of errors, defects or failures. We may fail to detect or cure defects\nas a result of a number of factors, many of which are outside our control, including: technical or mechanical malfunctions in the production\nprocess; human error or malfeasance by our quality control personnel; tampering by third parties; and defective raw materials or equipment.\n\n \n\n**Major\nSuppliers**\n\n \n\nWe\nsource our suppliers through multiple channels, including through (i) referrals from local medical device industry associations, (ii)\nindustry exhibitions/expos, and (iii) online research.  \n\n \n\nOur\nsuppliers are primarily divided into two categories: (i) those providing raw materials including flasks, tubes and nutrients\nused to maintain our population of insects for the manufacture of our MEDIFLY products, and (ii) those providing near finished cosmeceutical\nproducts, starting in April 2023. All of our suppliers are certified and qualified suppliers in Singapore or mainland China. Our raw\nmaterials supply has been stable and such materials are easily sourced due to our unique geographical location of operating in Singapore,\na major trade hub in Asia.\n\n \n\nWe\ndo not have long-term written purchase agreements with our suppliers. We usually place purchase orders with our suppliers based on our\nneed. We do not consider any of our suppliers to be material to our business. As of the date of this Annual Report, we had\na total number of approximately ten suppliers. We can utilize any supplier we determine at our sole discretion. Although\nwe can utilize any supplier we determine, we believe that we established healthy and stable relationships with our suppliers.\n\n \n\nFor\nthe years ended December 31, 2024 and year ended December 31, 2025, our purchases from our five largest suppliers collectively accounted\nfor 85.4% and 74.8%, respectively, of our cost of sales, and purchases from our largest supplier accounted for approximately 67.4% and\n22.6%, respectively, of our total cost of sales. The concentration of our major suppliers increased significantly for the year ended\nDecember 31, 2025 as a result of our cost-cutting measure of consolidating suppliers of plastic vials used to contain the\nmaggots for our MEDIFLY products to secure favorable bulk purchase prices.\n\n \n\n**Reimbursement,\nClinical Validation, and Clinical Utility**\n\n \n\nWe\ndo not promote our products based on their reimbursement status. However, we are mindful of the benefits of a favorable\nreimbursement coverage status to increase patient access and support our research and development efforts to supply the highest\nefficacy solutions.\n\n \n\n**Singapore**\n\n \n\nIn\nthe public healthcare sector, our maggot-based chronic wound care products are subsidized under the MediSave Scheme and classified as\none of the approved inpatient day surgery treatment options.\n\n \n\n**Hong\nKong**\n\n \n\nIn\nthe public healthcare sector, we are currently registered with the Hospital Authority’s central supplier database and our products\nare subsidized at all public hospitals in Hong Kong.\n\n \n\n**Competition**\n\n \n\nThe\nwound care market is highly competitive and subject to rapid technological change. Success in this market depends primarily on product\nefficacy, ease of product use, product price, availability of coverage and adequate third-party reimbursement, customer support services\nfor technical, clinical, and reimbursement support, and customer preference for, and loyalty to, the products. We believe that the positive\nclinical evidence of our products currently on offer and in pipeline, our strong cooperation with our local partners, our customer relationships\nand reputation offer us advantages over our competitors.\n\n \n\nThe\nwound care market is served by several large international companies as well as a number of small local companies. Our current and future\nproducts compete with biotherapeutic wound care products, collagen-based wound care products and other biopharmaceutical products. Manufacturers\nand distributors of competitive products include large multinationals including Smith & Nephew plc, ConvaTec Group plc, Mölnlycke\nHealth Care AB, 3M, Integra Urgo Group, among others and other local companies operating in the geographic markets that we currently\noperate or intend to enter in the future. Many of our competitors are significantly larger than we are and have greater financial and\npersonnel resources.\n\n \n\n56\n\n \n\n \n\nWe\nare aware of several companies that compete, or are developing technologies, in our current and future product areas. As a result, we\nexpect competition may become intense in the future. Our ability to compete successfully will depend on our ability to develop proprietary\nproducts that reach the market in a timely manner, receive adequate coverage and reimbursement, are cost effective, and are safe and\neffective.\n\n \n\nFor\nour cosmeceuticals business, in the global market, there are currently no direct competitors that commercially offer bullfrog collagen-based\ncosmeceutical products which we intend to explore the possibility of developing and commercializing in the future. However, we are aware\nthat there are multiple indirect competitors in the cosmeceuticals industry that offer products containing collagen derived from other\nsources. These include several companies in mainland China such as Giant Biogene, Guangzhou Trauer Biotechnology Co. Ltd., and Shanxi\nJinbo Biopharmaceutical Ltd., as well as companies in Germany, Italy, Japan, and the United States. Despite the presence of these indirect\ncompetitors, we believe our unique value proposition in the cosmeceuticals industry lies in the superiority of our bullfrog collagen\ncompared to collagen sourced from other animals, such as marine, bovine and porcine sources. However, we do not currently sell any cosmeceutical\nproducts that incorporate bullfrog collagen and there is no guarantee that we will be able to successfully develop and commercial these\nproducts.\n\n \n\nWe\nalso compete in the marketplace to recruit and retain qualified scientific, management and sales personnel, as well as to acquire technologies\nand technology licenses complementary to our products or advantageous to our business.\n\n \n\n**Laws\nand Regulations Relating to Medical Devices**\n\n \n\nOur\noperations are subject to comprehensive laws and regulations in the jurisdictions in which we or our R&D partners or affiliates do\nbusiness. For more information regarding the relevant laws and regulations on medical devices in different jurisdictions relevant to\nour business operations, see “- Regulations” in this section.\n\n \n\n**Our\nRegulatory Roadmap and Approval Timeline**  \n\n \n\nFor\nour MEDIFLY products, below is the current regulatory application and approval status with various regulatory authorities around the\nworld. However, we may not be able to receive the necessary regulatory approvals from the authorities in the intended markets where we\nplan to introduce them on the timeline envisioned below, or at all.\n\n \n\n \n●\nSingapore:\nOur MEDIFLY products have obtained the registration under the relevant laws and regulations and are currently listed on the Singapore\nMedical Device Register as a Class C medical device.\n\n \n \n \n\n \n●\nUnited\nStates: we are currently in the process of compiling the technical documentation required for an FDA 510(k) clearance, including\ncompliance with the FDA’s Quality Management System Regulation. The 510(k) clearance process is a premarket submission made\nto the FDA to demonstrate substantial equivalence to a legally marketed predicate device. We submitted our 510(k) application to\nthe FDA and received a Request for Additional Information in November 2025, to which we are currently preparing our response.\n\n \n\n \n●\nMainland\nChina: we have commenced our product classification application process with the NMPA in November 2022 and expect to receive the\nclassification announcement after receiving FDA 510(k) clearance, which will be used as a reference document.\n\n \n \n \n\n \n●\nHong\nKong: we currently ship MEDIFLY products from Singapore to Hong Kong for sale. This is permissible using our import permit issued\nby the Port Health Division under the Department of Health of Hong Kong.\n\n \n \n \n\n \n●\nSoutheast\nAsia: Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, Philippines, Singapore, Thailand and Vietnam utilize a harmonized medical\ndevice regulatory framework under the ASEAN Medical Device Directive (AMDD) agreement. We plan to use the Common Submission Dossier\nTemplate (CSDT) to commence the registration of MEDIFLY products, in jurisdictions where partnerships have been established.\n\n \n \n \n\n \n●\nSaudi\nArabia: we have commenced our application in Saudi Arabia with SFDA in 2024. In March 2026, Cuprina MENA Co. Ltd received official\nproduct classification from the SFDA for MEDIFLY as a Medical Device–Drug combination product, with the primary mode of action\nregulated under the medical device framework. This allows us to finalize the scientific and technical requirements necessary for\nthe commercial distribution of MEDIFLY across Saudi Arabia’s healthcare network. Cuprina MENA Co. Ltd continues to assist us\nwith the application and approval process.\n\n \n\n57\n\n \n\n \n\nFor\nthe bullfrog collagen sponge dressing product currently in our pipeline, we have completed the set-up of our CGMP-compliant pilot production\nfacility in our laboratory in Singapore for the extraction and formulation of the bullfrog collagen wound care products, and have conducted\nthe necessary production runs for process validation and product consistency.\n\n \n\nBelow\nis the current regulatory application and approval status with various regulatory authorities around the world for the bullfrog collagen\nsponge dressing. However, we may not be able to receive the necessary regulatory approvals for our bullfrog collagen sponge dressing\nproduct from the regulatory authorities in the jurisdictions below on the timeline currently envisioned, or at all.\n\n \n\n \n●\nUnited\nStates: We have optimized a new manufacturing step and are in the process of resubmitting the product for ISO 10993 biocompatibility\ntesting. Subject to satisfactory biocompatibility results, we intend to commence safety and efficacy clinical trials with a local\nhospital partner in Singapore by the end of 2026. Our 510(k) submission to the FDA, which requires compliance with the FDA’s\nQuality Management System Regulation, is planned to follow the completion of the ISO 10993 biocompatibility testing and any additional\nclinical or performance data requirements as may be determined by the FDA, subject to the progress of the relevant R&D work and\nregulatory requirements.\n\n \n \n \n\n \n●\nSingapore:\nUpon receiving FDA 510(k) clearance, we plan to register our bullfrog sponge dressing with the HSA. Since the FDA is a reference\nregulatory agency for HSA, obtaining an FDA 510(k) clearance will enable us to utilize the abridged registration route allowed under\nthe relevant regulatory framework to expedite our regulatory process. The timeline for obtaining HSA approval typically spans between\n160 and 220 working days, excluding the duration required for addressing additional information inquiries.\n\n \n \n \n\n \n●\nSoutheast\nAsia: Upon obtaining Singapore HSA approval, we plan to use the Common Submission Dossier Template (CSDT) to register our bullfrog\ncollagen sponge dressing in Southeast Asian jurisdictions where partnerships have been established.\n\n  \n\nOther\nwound dressing products using bullfrog collagen, such as a hydrogel, are expected to be on an accelerated regulatory timeline as the\nbiocompatibility tests for bullfrog collagen are anticipated to be completed in the second half of 2026 to 2027. As such,\nwe expect the bullfrog collagen hydrogel to become commercially available thereafter in the United States. We will commence the application\nprocess for our pipeline products once the relevant R&D work is validated and is complete.  \n\n \n\nFor\nour commercialized and pipeline cosmeceuticals products, as well as those product candidates incorporating bullfrog collagen, there are\nno product approval process that is required from any regulatory authorities in any of the markets that we intend to operate, as long\nas the cosmeceuticals do not make any therapeutic claims.\n\n \n\n**Facilities**\n\n \n\nAs\nof the date of this Annual Report, we do not own any properties. We have leased the following properties, all of which are located in\nSingapore:  \n\n \n\nNo. \nLocation \nApproximate\n\nGross Area (sq m)  \nLessor \nUsage \nLease\n\nExpiration Date\n\n1 \nBlock 1090, Lower Delta Road, #06-08, Singapore 169201. \n 93.5  \nDBS Trustee Limited \nManufacturing and distribution of medical devices \nOctober 31, 2028\n\n2 \nBlock 1090, Lower Delta Road, #06-10, 11, 12 & 13, Singapore 169201. \n 362.8  \nDBS Trustee Limited \nDistribution, storage of medical devices and ancillary office \nSeptember 23, 2028\n\n \n\n58\n\n \n\n \n\n**Intellectual\nProperty**\n\n \n\nThe\nwound care products that we currently offer and those in our pipeline are inspired by medical techniques that have been utilized for\ncenturies across various regions worldwide. We modernize and advance these natural techniques based on modern medical standards and processes\nto improve patient outcomes and enhance the operational efficiency of healthcare providers. As a result, we have not, as of the date\nof this Annual Report, relied on patents to protect our proprietary technology or intellectual property. Rather, we rely\non and expect to continue to rely on in the future trade secrets, know-how and related non-patent intellectual properties to develop\nand maintain our competitive position, as well as protect aspects of our business that are not amenable to, or that we do not consider\nappropriate for, patent protection. Our currently commercialized chronic wound care line of products, namely, MEDIFLY products, from\nwhich we derived 71.2% of our revenue in 2024 and 88.6% of our revenue for the year ended December 31, 2025, have no patent\nprotection, and rely primarily on trade secrets and know-how relating to the optimized process and conditions for the identification\nof native blowflies, and the collection and breeding of blowflies sustainably to produce sufficient medical grade maggots in insectaries\nthat meet the relevant containment standards. For more information regarding the lack of patent protection for our MEDIFLY products,\nsee “Risk Factors - Risks Relating to Our Business and Industry - Our maggot-based chronic wound care products are not currently\nprotected by any pending patent application nor any unexpired patent. Currently, the substantial majority of our net revenue is derived\nfrom the sale of maggot-based chronic wound care productions and such products may be subject to competition from the sale of substantially\nequivalent products that could adversely affect our business and operations.”\n\n \n\nTherefore,\nit is our policy to protect trade secrets and/or know-how by establishing confidentiality agreements and invention assignment agreements\nwith our employees, consultants, scientific advisors, contractors and collaborators. These agreements provide that all confidential information\ndeveloped or made known during the course of an individual or entity’s relationship with us must be kept confidential during and\nafter the relationship. These agreements also provide that all inventions resulting from work performed for us or relating to our business\nand conceived or completed during the period of employment or assignment, as applicable, shall be our exclusive property. In addition,\nwe take other appropriate precautions, such as physical and technological security measures, to guard against misappropriation of our\nproprietary information by third parties.\n\n \n\nIn\nthe future, as we continue to develop our product portfolio, we may, in addition to non-patent intellectual properties such as trade\nsecrets and know-how, seek to obtain domestic and international patent protection by filing patent applications as we conduct research\nand development on our future products and initiate new projects. We strive to operate without infringing on the proprietary rights of\nothers and endeavor to promptly file patent applications for new commercially valuable inventions.\n\n \n\nAs\nof December 31, 2025, apart from the intellectual property we licensed from NTU through our licensing arrangement with NTU, we did not\npossess any patents or trademarks, nor had we submitted any patent applications. Pursuant to the said licensing agreement with NTU, we\nwere granted an exclusive license to develop, make, have made, import into, export from, offer for sale, sell and have sold products\ndeveloped incorporating licensed technology primarily including a utility patent application relating to bullfrog skin-derived collagen\nand its use as a wound dressing material and unpublished R&D information, technical information, manufacturing technology, formulae,\ndata, protocols, designs and other information in relation to bullfrog skin-derived collagen and its use as a wound dressing material.\nThe utility patent application was filed in the United States on April 16, 2021, and it will expire 20 years from the filing date. The\nlicensed technology is primarily utilized for the development of our wound care pipeline products, specifically sponge dressings and\nhydrogel that incorporate bullfrog collagen. Please see “– Research and Development – Licensing Agreement with NTU”\nin this section for additional details.\n\n \n\nIn\naddition, through our 50.1%-owned joint venture company established pursuant to the Joint Venture Agreement with Aiodine Laboratory Pte.\nLtd. dated November 18, 2025, we have access to a worldwide exclusive license to distribute, market, and commercialize Aiodine’s\nproprietary iodine-based wound care and topical antiseptic products for the duration of the agreement. The Aiodine brand name and related\ntrademarks remain the property of Aiodine Laboratory Pte. Ltd. and are exclusively licensed to the joint venture company during the term\nof the agreement. Any intellectual property, data, know-how, or proprietary rights developed through the resources, funding, or personnel\nof the joint venture company will be owned by the joint venture company. Each party retains ownership of intellectual property independently\ndeveloped outside the scope of the joint venture. Our interest in the intellectual property rights of the joint venture company flows\nthrough its 50.1% shareholding therein.\n\n \n\n**Internet\nDomain Names**\n\n \n\nAs\nof the date of this Annual Report, we have registered the domain names https://www.cuprina.com, https://www.cuprinawoundcare.com, and\nhttps://activlabs.co.\n\n \n\n**Employees**\n\n \n\nWe\nhad 10 full-time employees as of December 31, 2025. The following table sets forth the numbers of our full-time employees,\ncategorized by function, as of the same date:\n\n \n\nRole \nNumber of\nEmployees \n\n  \n  \n\nManagement & Finance \n 2 \n\nBusiness Development, Sales and Marketing \n 3 \n\nResearch and Development \n 2 \n\nQuality Assurance and Regulatory Affairs \n 1 \n\nProduction \n 2 \n\nTotal \n 10 \n\n \n\nAll\nof our employees are located in Singapore. Employees are not covered by collective bargaining agreements. We consider our labor practices\nand employee relations to be good. As of the date of this Annual Report, we have not experienced any material labor disputes.\n\n \n\n59\n\n \n\n \n\n**Licenses,\nPermits, Registrations and Approvals**\n\n \n\nOur\nprincipal business activities are located in Singapore and are subject to regulation by applicable laws, regulations and government agencies\nin Singapore. These regulations require us to possess various approvals and certifications in respect of certain of the heavy equipment\nwe supply.\n\n \n\nBelow\nis a list of material licenses and permits that we have as of the date of this Annual Report:   \n\n \n\n**Name**\n \n**Issuing\nauthority**\n \n**Commencement\ndate**\n \n**Expiration\ndate**\n\n \n \n \n \n \n \n \n\nImport\nPermit\n \nPort\nHealth Division under the Department of Health of Hong Kong\n \n24/11/2025\n \n01/12/2026\n\n \n \n \n \n \n \n \n\nApproved\nVendor Master\n \nThe\nHospital Authority of Hong Kong\n \nApril\n2023\n \nNo\nExpiry Date\n\n \n \n \n \n \n \n \n\nDealer’s\nLicense - Manufacturer\n \nHealth\nSciences Authority of Singapore\n \n25/02/2020\n \n30/11/2026\n\n \n \n \n \n \n \n \n\nMedical\nDevice Dealer’s License\n \nHealth\nSciences Authority of Singapore\n \n12/02/2020\n \nNo\nExpiry Date\n\n \n \n \n \n \n \n \n\nMedical\nDevice Listing\n \nHealth\nSciences Authority of Singapore\n \n\n08/04/2013\n(issued)\n\n08/01/2021\n(change of ownership)\n\n \n07/04/2027\n\n \n \n \n \n \n \n \n\nLicense\nto Collect, Keep, Breed and Sell *Lucilla Cuprina*\n \nNational\nEnvironmental Agency of Singapore\n \n15/01/2019\n \n19/01/2027\n\n \n\n*****\n \n\n \n\n**Corporate\nSocial Responsibility**  \n\n \n\nWe\nrecognize our responsibilities to our employees, shareholders, business partners and the community as a whole, and are committed to achieving\nlong term mutually sustainable relationships with our stakeholders.\n\n \n\nWe\nare constantly searching for means to contribute to the community and we intend to set aside funds to be used for our corporate social\nresponsibility activities every year. In pursuit of enriching the community we serve, we plan to set aside a portion of our profits towards\ncorporate social responsibility endeavors. We were among the winners of the Enterprise Singapore Sustainability Open Innovation Challenge\n2021, a competition launched by Enterprise Singapore under the Ministry of Trade and Industry of the Government of Singapore, that aims\nto bring together industry partners and creative innovators to co-develop sustainable solutions in key areas such as low carbon alternatives\nand sustainable materials. In addition, we launched our “Cuprina Cares” initiative with the aim to support individuals in\nSingapore who lack access to MDT treatment due to financial difficulties in August 2023. We have published the relevant information relating\nto our initiative, including how to participate in the initiative, on https://cuprina.com/cuprina-cares. As of the date of this Annual\nReport, we had not received any applications from the general public.\n\n \n\n**Seasonality**\n\n \n\nRevenues\nduring our fourth quarter tend to be stronger than other quarters because many hospitals increase their purchases of our products during\nthe fourth quarter to coincide with the end of their budget cycles. Satisfaction of patient deductibles through the course of the year\nalso results in increased revenues later in the year. In general, our first quarter usually has lower revenues than the preceding fourth\nquarter, the second and third quarters have higher revenues than the first quarter, and the fourth quarter revenues are the highest in\nthe year.\n\n \n\n60\n\n \n\n \n\n**REGULATIONS**\n\n \n\nThis\nsection sets forth a summary of the most significant rules and regulations that affect our business and operations.\n\n \n\n**Laws\nand Regulations Relating to Medical Devices and Cosmeceutical Products**\n\n \n\nOur\noperations are subject to comprehensive laws and regulations in the jurisdictions in which we or our R&D partners or affiliates do\nbusiness. The laws and regulations governing our business and interpretations of those laws and regulations are subject to frequent change.\nOur ability to operate profitably will depend in part upon our ability, and that of our R&D partners and affiliates, to operate in\ncompliance with applicable laws and regulations. The laws and regulations relating to medical products and healthcare services that apply\nto our business and that of our partners and affiliates continue to evolve, and we must, therefore, devote significant resources to monitoring\ndevelopments in legislation, enforcement, and regulation in such areas. As the applicable laws and regulations change, we are likely\nto make conforming modifications in our business processes from time to time. We cannot provide assurance that a review of our business\nby courts or regulatory authorities will not result in determinations that could adversely affect our operations or that the regulatory\nenvironment will not change in a way that restricts our operations.\n\n \n\n**Singapore**\n\n \n\n*Introduction*\n\n \n\nOur\noperating subsidiary incorporated in Singapore, Cuprina Pte. Ltd. (the “Singapore Subsidiary”), is subject to all relevant\nlaws and regulations of Singapore, and may also be affected by new laws, regulations and policies which are introduced by the Singapore\ngovernment from time to time. We have identified the main laws and regulations (apart from those pertaining to general business requirements)\nthat we anticipate may materially affect the Singapore Subsidiary’s operations, the relevant regulatory bodies and the licenses,\npermits and approvals typically required for the conduct of the Singapore Subsidiary’s business in Singapore.\n\n \n\nThe\nfollowing description is a summary of material laws and regulations applicable to the Singapore Subsidiary’s operations in Singapore.\nThe laws and regulations set out below are not exhaustive and are only intended to provide general information to investors and are neither\ndesigned nor intended to be a substitute for professional advice. Prospective investors should consult their own advisers regarding the\nimplication of the relevant laws and regulations on us.\n\n \n\nAs\nof the date of this Annual Report, we have not commenced any clinical trials in Singapore. However, we are planning to commence safety\nand efficacy clinical trials with a local hospital partner in Singapore for our bullfrog collagen sponge dressings by the end of 2026.\nAccordingly, the clinical trial regulations below are expected to become applicable when the Singapore Subsidiary and/or any of its subsidiaries\ncommences clinical operations and/or clinical trials in Singapore.\n\n \n\n*Overview\nof Regulatory Landscape*\n\n \n\nIn\nSingapore, the chronic wound care products and cosmeceutical products (as aforementioned in the section “Our Products” above)\nare regulated by the Health Products Act 2007 (“HPA”), the Health Products (Medical Devices) Regulations 2010 (“HP(MD)R”)\nand the Health Products (Cosmetic Products — ASEAN Cosmetic Directive) Regulations 2007 (“HP(CP-ACD)R”). These pieces\nof legislation are administered by the HSA, a statutory board under the Ministry of Health of Singapore (“MOH Singapore”).\nAdditionally, the chronic wound care products may also be subject to regulation under the Human Biomedical Research Act 2015 (“HBRA”),\nwhich is administered by the Director-General of Health of the MOH Singapore, during any potential clinical trial phase in Singapore.\n\n \n\nThe\nHSA, established under the Health Sciences Authority Act 2001, is overseen by MOH Singapore, and its functions, objects and duties include,\namongst others:\n\n \n\n \n1.\nRegulating\nthe manufacture, import, export, sale, supply, advertisement and use of health products in accordance with the applicable written\nlaws; and\n\n \n \n \n\n \n2.\nConducting\ntechnological assessments of health products to determine their quality, safety, efficacy and suitability for consumption and use\nin Singapore and to advise the Singapore government thereon.\n\n \n\nApart\nfrom the laws and regulations below which are administered by HSA and/or MOH Singapore, the Singapore Subsidiary must comply with all\napplicable circulars, directives and guidance released by HSA and/or MOH Singapore from time to time as well. The Singapore Subsidiary’s\nbusiness is generally regulated under the HPA, with subsidiary legislation and guidelines as promulgated by HSA and MOH Singapore.\n\n \n\nSeparately,\nwe note that the breeding of *Lucilia cuprina*flies is regulated by the Control of Vectors and Pesticides Act 1998 (“CVPA”)\nwhich is in turn administered by the Director-General of Public Health (“DGPH”) of the National Environment Agency (“NEA”),\na statutory board under the purview of the Ministry of Sustainability and the Environment.\n\n \n\n61\n\n \n\n \n\nAdditionally,\nwe note that personal data is regulated under the Personal Data Protection Act 2012 (“PDPA”) and that issues may arise out\nof research or clinical trials and regulated under Singapore. For more information on the PDPA, please see the section “Regulations\non Data Protection” below.\n\n \n\n*Classification\nof Chronic Wound Care and Cosmeceutical Products under the HPA*\n\n \n\nUnder\nthe First Schedule of the HPA, health products are classified into: (i) medical devices; (ii) cosmetic products; (iii) therapeutic products;\n(iv) oral dental gum; and (v) cell, tissue or gene therapy products. The two most pertinent classifications would be: (a) medical devices,\nwhich are defined as, among other things, “any instrument, apparatus, implement, machine, appliance, implant, reagent for in-vitro\nuse, software, material or other similar or related article that is intended by its manufacturer to be used, whether alone or in combination,\nfor humans for certain specified purposes, including the: (i) treatment or alleviation of disease; (ii) treatment or alleviation of an\ninjury, and which does not achieve its primary intended action in or on the human body by pharmacological, immunological or metabolic\nmeans”; and (b) cosmetic products, which are defined as, among other things, “any substance or preparation that is intended\nby its manufacturer to be placed in contact with the various external parts of the human body, with a view exclusively or mainly to:\n(i) protecting them; or (ii) keeping them in good condition”.\n\n \n\nAs\naforementioned, our products comprise chronic wound care products and cosmeceutical products. Our chronic wound care products include\nour commercialized product MEDIFLY (a medical grade sterile live blowfly larvae bio-dressing) and our pipeline products include (i) hirudotherapy\n(i.e., medical leech therapy); (ii) bullfrog collagen sponge dressing and (iii) bullfrog collagen hydrogel. Through our 50.1%-owned joint\nventure company with Aiodine Laboratory Pte. Ltd., we also have access to a range of iodine-based wound care and topical antiseptic products.\nOur commercialized cosmeceutical products include (i) MEND Skin Restoration Balm (i.e., a hydrating balm); (ii) ENDURE Muscle Energy\nCream; and (iii) Activ Labs Cool Relief Muscle Patch. All of our chronic wound care products are likely to be classified as medical devices.\n\n \n\nIn\nrespect of the iodine-based wound care and topical antiseptic products distributed through our joint venture company with Aiodine Laboratory\nPte. Ltd., these products are likely to be classified as topical antiseptics and regulated under the Medicines Act (Chapter 176) and\nits subsidiary legislation. Topical antiseptics are not subject to pre-market approval or licensing by HSA for their importation, manufacture\nand sale in Singapore. Dealers are nonetheless required to ensure that such products are safe and conform to applicable HSA guidelines\nand quality standards. A valid permit from HSA is required before publishing any medical advertisement or conducting any sales promotion\ndirected at the general public in respect of such products.\n\n \n\nIn\nrespect of our cosmeceutical products, the MEND Skin Restoration Balm would likely be classified as a cosmetic product whilst the ENDURE\nMuscle Energy Cream and Activ Labs Cool Relief Muscle Patch would likely be respectively classified as a health supplement and medicated\npatch, both of which are categories of products excluded from the definition of therapeutic products (being one of the categories of\nhealth products set out in the First Schedule of the HPA) and thus would not be subject to the regulations of the HPA.\n\n \n\n*Regulatory\nRequirements in Singapore specific to Medical Devices and Regulatory Status of Our Medical Device Products*\n\n \n\nMedical\ndevices in Singapore are regulated by the HPA, HP(MD)R and HBRA. All companies are required to obtain a license from HSA before manufacturing,\nimporting or supplying medical devices (and other health products) wholesale in the country.\n\n \n\nCompanies\nare obligated to notify HSA prior to making any changes to their medical devices, including technical changes, review changes, administrative\nchanges, notification changes and changes arising from field safety corrective actions (“FSCAs”), which are actions taken\nto reduce the risk of death or serious deterioration in the state of health of a person associated with the use of a medical device.\n\n \n\n*Device\nPremarket Regulatory Requirements.*Product registration applications for medical devices submitted to HSA must follow the format\noutlined in the ASEAN Common Submission Dossier Template (“ASEAN CSDT”)*.*The various sections of the ASEAN CSDT and\ntheir respective contents are detailed in GN17: Guidance on Preparation of a Product Registration Submission for General Medical Devices\nusing the ASEAN CSDT and GN18: Guidance on Preparation of a Product Registration Submission for In Vitro Diagnostic (IVD) Medical Devices\nusing the ASEAN CSDT.\n\n \n\nThe\nkey sections covered include:\n\n \n\n \n●\nEssential\nprinciples and evidence of conformity;\n\n \n●\nDevice\ndescription;\n\n \n●\nDesign,\nverification & validation;\n\n \n●\nClinical\nevidence; and\n\n \n●\nRisk\nanalysis.\n\n \n\n62\n\n \n\n \n\nHSA\nclassifies medical devices into four risk classes based on their inherent risk, which depends substantially on the intended purpose and\neffectiveness of risk management techniques applied during design, manufacture and use. The four classifications are:\n\n \n\n \n●\nClass\nA: This includes low-risk medical devices that do not enter the body, such as tongue depressors, bandages, and surgical gloves.\n\n \n●\nClass\nB: This includes low to moderate-risk medical devices that come into contact with the body, such as syringes, catheters, and surgical\ninstruments.\n\n \n●\nClass\nC: This includes moderate to high-risk medical devices that are implanted into the body, such as pacemakers, heart valves, and joint\nreplacements.\n\n \n●\nClass\nD: This includes the high-risk medical devices, such as life-support machines, and devices that are used for the diagnosis and treatment\nof serious diseases, such as cancer.\n\n \n\nOther\nconsiderations in risk classification include the intended user(s), mode of operation and technology used. Factors influencing risk classification\nof a general medical device include contact duration with the body, degree of invasiveness, whether the device delivers medicinal products\nor energy to the patient, whether it is intended to have a biological effect on the patient, local versus systemic effects, etc.\n\n \n\n*Essential\nPrinciples for Safety and Performance.*Medical devices must also conform to the Essential Principles for Safety and Performance checklist,\nwhich outlines fundamental design and manufacturing requirements. The company must identify which design and manufacturing requirements\nare relevant for a particular medical device. Where requirements are deemed not applicable, the rationale must be documented. This applies\nto all medical devices. Pursuant to the HP(MD)R, companies are required to declare that their devices are classified as per the classification\nrules and conform to the Essential Principles for Safety and Performance regulatory guidance as issued by the HSA.\n\n \n\n*Labeling\nRequirements.*Companies must label their medical devices according to HSA requirements. Device labeling (e.g. physical labels, instructions\nfor use, implementation manuals, etc.) helps users: (i) identify the device; (ii) communicate safety and performance information; and\n(iii) ensure device traceability. Essential details like device name and manufacturer’s information must be on labels for identification.\nSafety and performance information like intended use, instructions for proper use and safety warnings are also clearly presented for\nusers’ reference.\n\n \n\n*Device\nPost-market Regulatory Requirements.*Post-market surveillance is mandated for all medical devices supplied in Singapore, in accordance\nwith the HPA and the HP(MD)R.\n\n \n\nEvery\nmanufacturer, importer, supplier or registrant of a medical device must maintain records of complaints received and produce these records\nfor HSA inspections when required to do so by the HSA. The records must contain detailed information specified in the HP(MD)R. Companies\nare required to plan, establish, document, implement, maintain, and update a Post-Market Surveillance (“PMS”) system for\ndevices placed on the Singapore market. The PMS system must be designed and documented in a PMS plan, and constantly updated based on\nstructured assessments of its performance and yielded data.\n\n \n\nEvery\nmanufacturer, importer, supplier or registrant of a medical device must, upon becoming aware of any defect in the medical device or any\nadverse effect that has arisen from the use thereof, inform the HSA of the defect or adverse effect: (a) within 48 hours, if the information\nrelates to any defect or adverse effect that represents a serious threat to public health; (b) within 10 days, if the information relates\nto an incident that has led to the death, or a serious deterioration in the state of health, of a patient, a user of the medical device\nor any other person; and (c) within 30 days, if the information relates to an incident a recurrence of which might lead to the death,\nor a serious deterioration in the state of health, of a patient, a user of the medical device or any other person.\n\n \n\nThe\nPMS plan collects data from various sources including:\n\n \n\n \n●\nSerious\nincidents;\n\n \n●\nFSCAs;\n\n \n●\nComplaints;\n\n \n●\nDatabases\nand/or registries; and\n\n \n●\nFeedbacks.\n\n \n\nIn\naddition to PMS requirements for manufacturers, there are specific adverse event and FSCA reporting requirements for all economic operators\n(manufacturers, importers, distributors, local authorized representatives).\n\n \n\nPossible\nFSCAs include:\n\n \n\n \n●\nProduct\nrecall;\n\n \n●\nProduct\nreplacement;\n\n \n●\nProduct\ndestruction;\n\n \n●\nProduct\nmodification including retrofitting;\n\n \n●\nPermanent\nor temporary labeling;\n\n \n●\nPermanent\nor temporary changes to the instructions for use; and\n\n \n●\nSoftware\nupgrades.\n\n \n\n63\n\n \n\n \n\nAn\nFSCA must be reported if the medical device is manufactured, imported or supplied in Singapore, or is registered or authorized for supply\nin Singapore (even if not currently on the market). The reporting person should be the dealer who manufactured, imported, supplied or\nregistered the concerned device. Where multiple dealers are involved, each must report the FSCA individually.\n\n \n\nBefore\ninitiating an FSCA, the dealer must notify HSA. Once reported, the dealer can proceed without waiting for HSA approval. Medical device\ndealers must report FSCAs via the Online Safety, Compliance Application and Registration System.\n\n \n\n*Laws\nand Regulations relating to Advertising, Fraud and Abuse and Transparency Laws and Regulations.* The legislative control for the advertisement\nof medical devices is outlined in the HPA - Part 5 Advertisement of Health Products, Sections 19-23, and the HP(MD)R. Any person advertising\nor causing the advertisement of a product as a medical device must comply with Part 5 of the HPA and the HP(MD)R.\n\n \n\nPrior\napproval by the HSA is not required for advertisements of medical devices, but compliance with the requirements stated in the HPA and\nthe HP(MD)R is mandatory. Products should not be advertised as a medical device or claim to function as a medical device if they do not\nmeet the definition provided in the First Schedule to the HPA. Advertisements must not contain false information or give any erroneous\nimpression regarding the formulation, composition, design specification, safety, efficacy, or uses of the medical device. Any representation\nof a medical device must be factual and supported by objective evidence.\n\n \n\nIn\nthe case of registered medical devices, all advertised claims must align with the indications and instructions for use (IFU) registered\nwith the HSA. Information not registered or that may potentially extend the usage of a registered medical device must not be included\nin advertisements. Advertisements for exempted medical devices, i.e., Class A medical devices, must align with the product owner’s\nspecifications and comply with any relevant conditions of registration that may be imposed.\n\n \n\nAdvertisements\nof medical devices that are registered as “Professional Use only” or unregistered but supplied in accordance with Regulation\n8 or 10 of the HP(MD)R cannot be advertised to the general public. Such advertisements are only allowed to be distributed to, or featured\nin publications mainly intended for qualified practitioners.\n\n \n\nAdvertisements\nof medical devices should not imply or suggest that the medical device can prevent, cure, or alleviate any disease or condition specified\nin the relevant laws and regulations unless the advertisement is distributed only to qualified practitioners, registered pharmacists,\nregistered nurses, registered midwives, and persons undergoing training with a view to becoming one of the aforementioned persons.\n\n \n\nAdvertisements\nof medical devices should not encourage self-diagnosis or self-treatment of serious diseases. Advertisements must not suggest that consumers\ndo not need to consult a doctor after using the medical device. Advertisements should not offer diagnoses or suggest that medical interventions\nsuch as surgical operations are not required by using the medical device advertised.\n\n \n\nAll\nproduct claims made in advertisements must be supported by scientific evidence, and the nature, quality, and properties of the medical\ndevice must be truthfully stated. Advertisements must not mislead readers or create unrealistic expectations regarding the safety, quality,\nor efficacy of the medical device. The use of superlatives or exaggerated claims should be avoided, and advertisements should not encourage\ninappropriate, indiscriminate, unnecessary, or excessive use of the medical device. Advertisements must not exploit the ignorance and\ncredulity of the public or misuse research results or make unnecessary quotations from technical and scientific publications.\n\n \n\nAdvertisements\nof medical devices must not denigrate or unfairly attack any other products, goods, or services, or any other sector of the industry.\nAny comparative statements must not mislead the public about the advertised product or any product it is compared to. Advertisements\nmust not cause fear, alarm, or distress to consumers, abuse trust, or exploit the lack of knowledge of any consumer.\n\n \n\nAdvertisements\nmust not contain any claim or statement suggesting that the results of using the medical device are guaranteed, extraordinary, or better\nthan any other identifiable treatment. Advertisements must not claim or imply that the medical device is 100% safe, has no side effects,\nor will not cause harm. False or erroneous claims indicating or suggesting that the use of the medical device is promoted, supported,\nor endorsed by the government or any public authority, including the HSA, must not be published.\n\n \n\n64\n\n \n\n \n\nRecommendations\nby healthcare professionals, including testimonials, support, and endorsements, must not be included in advertisements. Advertisers are\nadvised to use caution when featuring pharmacies, healthcare institutions, or scenes of surgical procedures that may give the perception\nof endorsement by a healthcare professional.\n\n \n\nThe\nHSA may require advertisers to furnish copies of medical device advertisements that have been advertised or are about to be advertised\nfor compliance review and investigation. If an advertiser contravenes the HPA and its regulations, the HSA may order the immediate cessation\nof the advertisement, reasonable measures to remove the offending advertisements that have been published/distributed, or the publication\nof a corrective advertisement containing specified information as per the HSA requirements.\n\n \n\n*MEDIFLY\nManufacturer’s License*. We currently hold a manufacturer’s license for our MEDIFLY product, which is registered as a\nClass C medical device. For more information on the classification of medical devices, please see the section “Government Regulation\n– Singapore” above. The conditions for such a license include:\n\n \n\n \n●\nSubmitting\n(upon HSA’s request) medical devices for batch testing in accordance with a product standard prescribed by HSA, to a testing\nbody recognized by HSA.\n\n \n●\nReporting\nto HSA all reportable changes to the license, including changes to our Company’s name, address and ISO 13485 certification,\nwithin 15 days after the date of implementation of the change.\n\n \n●\nNot\nusing the license in any form of advertisement.\n\n \n●\nSubmitting\n(upon HSA’s request) the ISO13485 audit report.\n\n \n●\nLabelling\nour MEDIFLY product, which is manufactured for supply in Singapore, with Unique Device Identifier (UDI) and complying with the UDI\nrequirements by the respective UDI compliance dates as set out on the HSA website.\n\n \n\n*Clinical\nTrials of Medical Devices.* Regarding clinical trials of medical devices, under the HBRA, appropriate consent must be obtained, amongst\nother requirements, in the presence of a prescribed witness, and in writing from research subjects or tissue donors for clinical trials.\nRelevant information must be provided before obtaining such appropriate consent. Such relevant information includes:\n\n \n\n \n●\nthe\ninvestigational nature of the biomedical research;\n\n \n●\nthe\npurpose of the biomedical research;\n\n \n●\nthe\nreasonably foreseeable risks, discomforts or inconveniences to a living research subject arising from the biomedical research;\n\n \n●\nthe\nbenefits which the research subject may reasonably expect from the biomedical research;\n\n \n●\nwhere\napplicable, whether there are alternative procedures or treatments available to the research subject, and the potential benefits\nand risks of such alternatives;\n\n \n●\nany\ncompensation and treatment available to the research subject due to injury arising from participation in the research;\n\n \n●\nany\nanticipated expenses the research subject is likely to incur when participating in the biomedical research;\n\n \n●\nthe\nextent to which information identifying the research subject will be kept confidential;\n\n \n●\nwhether\nindividually-identifiable information obtained from the research subject will be used for future biomedical research;\n\n \n●\nwhere\napplicable, whether biological material taken from the research subject will be destroyed, discarded or stored for future biomedical\nresearch;\n\n \n●\nwhether\nthe research subject’s participation involves information in individually-identifiable form;\n\n \n●\nany\ncircumstances under which, the research subject will be contacted for further consent, including changes in the proposed research,\nserious adverse events leading to a change in the proposed research, the development of capacity by minors to make decisions and\nany other circumstances specific to a particular research proposal;\n\n \n●\nwhether\nthe research subject would wish to be re-identified given an incidental finding, if the proposed biomedical research expressly provides\nfor such re-identification;\n\n \n●\nthe\nresearch subject’s right to withdraw consent (as specified in the HBRA) and the limitations of such withdrawal;\n\n \n●\nthe\nperson or persons to contact to obtain further information on the biomedical research and to provide feedback in relation to the\nbiomedical research, respectively;\n\n \n●\nsuch\nother information as the institutional review board may require; and\n\n \n●\nother\nrelevant information as may be prescribed.\n\n \n\nAdditionally,\nthe HBRA provides for additional safeguards when obtaining the appropriate consent of research subjects who are adults who lack mental\ncapacity or are minors (i.e., a person who is below 21 years of age and who has never been married). Where the research subject is an\nadult who lacks mental capacity, appropriate consent must be obtained from: (a) the donee or deputy (if any) who is authorized to give\nconsent on behalf of the said adult; or (b) where there is no donee or deputy who is authorized to give consent, such adult’s spouse,\nadult son or daughter, either parent or guardian, an adult brother or sister or person so named by the said adult as someone to be consulted\non the matter in question or on matters of that kind. Where the research subject is a minor then, depending on the circumstances involved,\nappropriate consent will have to be obtained from the minor and/or the minor’s adult parent or guardian or a deputy who is authorized\nto give consent on behalf of the minor.\n\n \n\n65\n\n \n\n \n\nFurther,\nunder the HBRA, research institutions (i.e., bodies of persons which engage researchers to conduct human biomedical research in Singapore\nand exercises supervision and control over human biomedical research so conducted) must appoint one or more institutional review boards\nto review human biomedical research conducted as supervised and controlled by the research institution. Human biomedical research may\nonly be conducted under the supervision of a research institution having a place of business in Singapore with least 2 individuals ordinarily\nresident in Singapore who are responsible for supervising and controlling the biomedical research. In addition, no person may conduct\nany human biomedical research unless he has:\n\n \n\n \n●\nmade\nnecessary arrangements with the research institution for the proposed research to be conducted under the supervision and control\nof the research institution;\n\n \n●\nensured\nthat the proposed research has been reviewed and approved (or exempted from review) by an institutional review board; and\n\n \n●\nobtained\nappropriate consent from the research subjects.\n\n \n\nThe\nHP(MD)R also regulates the manufacture, import and supply of medical devices used as clinical research materials. A person may manufacture\n/ import / supply (by wholesale or otherwise) a medical device without holding the required license, if the planned use for the medical\ndevice is a clinical purpose in any clinical research. Where the medical device is supplied for use in any investigational testing, the\nstatement “For Clinical Trial Use” or any other statement in English that conveys the same meaning should accompany the medical\ndevice.\n\n \n\nAdditionally,\nunder Regulation 39A of the HP(MD)R, every person who supplies any medical device whose planned use is for a clinical purpose in any\nclinical research must (a) maintain a record relating to every receipt (where applicable) and every supply by the person of the medical\ndevice; and (b) produce such record for inspection by the relevant regulatory or enforcement authorities. Regulation 39A also prescribes\nthe details that have to be maintained in the records.\n\n \n\nThe\nsponsor (i.e., a person who takes responsibility for the initiation, management or financing of any clinical research) must: (a) ensure\nthat no person involved in the clinical research uses the medical device except for a clinical purpose in the research, and where the\nresearch requires approval of an institutional review board, with the approval of that board; (b) maintain a record of the putting to\nsome other use, disposal or export of the medical device; and (c) produce such record for inspection by the relevant regulatory or enforcement\nauthorities. Regulation 39B also prescribes the details that have to be maintained in the records.\n\n \n\n*Regulatory\nRequirements applicable to the Breeding of Lucilia cuprina*\n\n \n\nThe\nCVPA prohibits the breeding, keeping, collecting, distributing, selling and import or export of any insect, including its egg, larva\nand pupa without the written permission of the DGPH.\n\n \n\nWe\nhave accordingly obtained a permit to collect, breed, keep and sell *Lucilia cuprina*flies for the purpose of MDT, which will expire\non 19 January 2027 if not renewed. This permit is subject to these conditions, amongst other conditions:\n\n \n\n \n●\nThe\npermit holder shall maintain all records, reports and other documentation relating to the type(s) of use for the permitted vectors\n(i.e., *Lucilia cuprina*) for 3 years.\n\n \n●\nThe\npermit holder shall, within such period as may be specified, make all records and other relevant documentation available for inspection\nand providing copies, at its cost, to the DGPH or his delegates.\n\n \n●\nThe\npermit holder shall report every breach of these conditions within 24 hours of any incident.\n\n \n●\nAny\nbreach of these conditions may result in the revocation of the permit.\n\n \n●\nThe\nDGPH can revoke, cancel or suspend the permit at any time without giving any reason and the permit holder shall have no right to\nany claim for loss of revenue or any other claim in respect of such cancellation or suspension.\n\n \n\n*Regulatory\nrequirements applicable to cosmetic products*\n\n \n\nThe\nHP(CP-ACD)R are given effect under the HPA, and came into operation on 1 January 2008. The HP(CP-ACD)R regulate the supply and advertisement\nof, and record-keeping and reporting obligations in relation to, cosmetic products.\n\n \n\n66\n\n \n\n \n\nA\nperson responsible for marketing a cosmetic product must notify HSA of the intention to place the said product on the market via the\nonline Pharmaceutical Regulatory Information System, before actually placing the product on the market. The notification shall be submitted\nto the HSA accompanied by such particulars, information, documents and samples of the cosmetic product as required by the HSA. A new\nproduct notification is required if changes are made to: (a) brand name; (b) product name; (c) product type; (d) formulation; and (e)\ncompany change of distribution rights. Particulars to be submitted to the HSA include:\n\n \n\n \n●\nParticulars\nof local company responsible for placing the cosmetic product in the market;\n\n \n●\nParticulars\nof manufacturer; and\n\n \n●\nParticulars\nof product.\n\n \n\nSeparately,\nfailing to adhere to stipulated requirements in terms of the content of cosmetic products can render the said product being deemed as\nan unwholesome product which cannot be manufactured in, imported into or supplied in Singapore. These requirements are listed below:\n\n \n\n \n●\nCosmetic\nproducts shall not contain substances found in Part I of the Third Schedule of the HP(CP-ACD)R. These substances are prohibited for\nuse in cosmetic products.\n\n \n●\nSubstances\nfound in Part II of the Third Schedule of the HP(CP-ACD)R, may only be used in cosmetic products provided the specified conditions\nare met. Depending on the substance, the conditions could be on the maximum concentration allowed to be used or labelling of special\nwarning on the product packaging.\n\n \n●\nOnly\ncoloring agents, preservatives or ultraviolet filters found in Parts III, IV and V respectively of the Third Schedule of the HP(CP-ACD)R\nare allowed to be used in cosmetic products. The use of coloring agents, preservatives and ultraviolet filters are subject to the\nconditions specified, if any.\n\n \n\nSeparate\nrequirements are applicable to the labelling of cosmetic products, including that:\n\n \n\n \n●\nA\ncosmetic product label must generally contain the: (i) product name, function and instructions on product usage; (ii) ingredient\nlist; (iii) product weight or volume in the immediate container or package; (iv) batch number of that product; (v) name and address\nin Singapore of the product marketer; (vi) name of the country where the product was manufactured; (vii) special precautions to be\nobserved when using the product; (viii) expiry date; and (ix) date of manufacture of the product.\n\n \n●\nSuch\ninformation must appear on the outer packaging, or otherwise on the immediate container or package, or in a product leaflet.\n\n \n●\nIngredients,\nif they appear in the: (i) International Cosmetic Ingredient Dictionary; (ii) British Pharmacopeia; (iii) United States Pharmacopeia;\nor (iv) Chemical Abstract Services, must generally be named according to the nomenclature in that standard reference, and be listed\nin descending order by weight, unless otherwise provided for in the HP(CP-ACD)R.\n\n \n●\nAll\ninformation on the label shall be in English, and any other language, and all numbers, letters and symbols shall be legible, permanent,\nindelible and prominent. If a symbol or code is used, an explanation of the symbol or color shall be provided.\n\n \n●\nThe\nlabel must not contain any statement, trademark, picture or other sign that: (a) the supply or use of the product is promoted or\nendorsed by HSA; or (b) likely creates an erroneous impression regarding the formulation, composition, quality or safety of the product.\n\n \n\nThere\nare several requirements applicable to claims made in advertising cosmetic products, including that:\n\n \n\n \n●\nClaims\nto modify a physiological process or to prevent or treat a disease / medical condition are forbidden.\n\n \n●\nClaims\nmust generally be justified scientifically and/or by the cosmetic formulation or preparation itself.\n\n \n●\nAll\nadvertising claims must be fully substantiated when requested by the HSA, and comply with the principles and guidelines set out in\nthe Singapore Code of Advertising Practice that is promulgated by the Advertising Standards Authority of Singapore.\n\n \n\nUnder\nthe HP(CP-ACD)R, we must keep records of all cosmetic products we supply or which have been supplied on our behalf in Singapore, which\nrecords must be produced for inspection upon HSA’s request. The records are to be retained for 2 years after the date on which\nthe product is supplied and shall contain the following information:\n\n \n\n \n●\nthe\nname and notification number of the product;\n\n \n●\nthe\ndate on which the product was so supplied;\n\n \n●\nname\nand address of the person to whom the product was so supplied;\n\n \n●\nthe\nquantity of the product so supplied; and\n\n \n●\nthe\nidentification number or mark (including the control number, lot number, batch number or serial number) of the product so supplied.\n\n \n\nWhere\nwe become aware of any event or other occurrence that concerns any adverse effect arising from the use of the cosmetic product, we must\nreport the adverse effect if the adverse effect has caused death, is life-threatening, has resulted in any person being hospitalized,\nor has caused any persistent or significant disability or incapacity in any person.\n\n \n\n67\n\n \n\n \n\n**United\nStates Regulation**\n\n \n\nThe\nFDA regulates, among other things, the development, design, non-clinical and clinical testing, manufacturing, safety, effectiveness,\nlabeling, packaging, storage, installation, servicing, recordkeeping, premarket clearance or approval, adverse event reporting, advertising,\npromotion, marketing and distribution, and import and export and post-marketing surveillance of medical devices in the United States\nto ensure that medical devices distributed domestically are safe and effective for their intended uses and otherwise meet the requirements\nof the Federal Food, Drug, and Cosmetic Act, or FDCA.\n\n \n\n*FDA\nPremarket Clearance and Approval Requirements*\n\n \n\nUnless\nan exemption applies, each new or significantly modified medical device commercially distributed in the United States requires either\nFDA clearance of a 510(k) premarket notification, or approval of a premarket approval, or PMA, application.\n\n \n\nUnder\nthe FDCA, medical devices are classified into one of three classes—Class I, Class II or Class III—depending on the degree\nof risk associated with each medical device and the extent of manufacturer and regulatory control needed to ensure its safety and effectiveness.\nClass I devices are those for which safety and effectiveness can be assured by adherence to the FDA’s general controls for medical\ndevices, which include compliance with the applicable portions of FDA’s CGMP for devices, as reflected in the Quality Management\nSystem Regulation, or QMSR, establishment registration and device listing, reporting of adverse medical events, and truthful and non-misleading\nlabeling, advertising, and promotional materials. Most Class I devices are exempt from the premarket notification requirements. Class\nII devices are subject to the FDA’s general controls, and any other special controls deemed necessary by the FDA to ensure the\nsafety and effectiveness of the device. These special controls can include performance standards, special labeling requirements, post-market\nsurveillance, patient registries and FDA guidance documents.\n\n \n\nMost\nClass II devices are required to submit to the FDA a premarket notification under Section 510(k) of the FDCA requesting permission to\ncommercially distribute the device. The FDA’s permission to commercially distribute a device subject to a 510(k) premarket notification\nis generally known as 510(k) clearance. Class III devices include devices deemed by the FDA to pose the greatest risks, such as life\nsustaining, life supporting or some implantable devices, or devices that have a new intended use, or use advanced technology that is\nnot substantially equivalent to that of a legally marketed device, requiring approval of a PMA. Due to the level of risk associated with\nClass III devices, the FDA’s general controls and special controls alone are insufficient to assure their safety and effectiveness.\nDevices placed in Class III generally require the submission of a PMA application demonstrating the safety and effectiveness of the device,\nwhich must be approved by the FDA prior to marketing, or the receipt of a 510(k) de novo classification, which provides for the reclassification\nof the device in Class I or II.\n\n \n\nThe\nPMA process is generally more costly and time-consuming than the 510(k) process. Through the PMA application process, the applicant must\nsubmit data and information demonstrating reasonable assurance of the safety and effectiveness of the device for its intended use to\nthe FDA’s satisfaction. The PMA application must provide valid scientific evidence that demonstrates to the FDA’s satisfaction\na reasonable assurance of the safety and effectiveness of the device for its intended use.\n\n \n\nIf\na new medical device does not qualify for the 510(k) premarket notification process because no predicate device to which it is substantially\nequivalent can be identified, the device is automatically classified into Class III.\n\n \n\nSome\npre-amendment devices are unclassified, but are subject to FDA’s premarket notification and clearance process in order to be commercially\ndistributed.\n\n \n\n*Investigational\nDevice Process*\n\n \n\nClinical\ntrials are almost always required to support a PMA and are sometimes required to support a 510(k) submission. In the United States, absent\ncertain limited exceptions, human clinical trials intended to support medical device clearance or approval or to determine safety and\neffectiveness of a device for an investigational use must be conducted in accordance with the FDA’s investigational device exemption,\nor IDE, regulations which govern investigational device labeling, prohibit promotion of the investigational device, and specify an array\nof recordkeeping, reporting and monitoring responsibilities of study sponsors and study investigators. If the device presents a “significant\nrisk,” to human health, as defined by the FDA, the FDA requires the device sponsor to submit an IDE application to the FDA, which\nmust become effective prior to commencing human clinical trials. The IDE application must be supported by appropriate data, such as animal\nand laboratory testing results, showing that it is safe to test the device in humans and that the testing protocol is scientifically\nsound. The IDE application must be approved in advance by the FDA for a specified number of subjects.\n\n \n\n68\n\n \n\n \n\nRegardless\nof the degree of risk presented by the medical device, clinical studies must be approved by, and conducted under the oversight of, an\nInstitutional Review Board, or IRB, for each clinical site. The IRB is responsible for the initial and continuing review of the IDE,\nand may pose additional requirements for the conduct of the study. If an IDE application is approved by the FDA and one or more IRBs,\nhuman clinical trials may begin at a specific number of investigational sites with a specific number of patients, as approved by the\nFDA. If the device presents a non-significant risk to the patient, a sponsor may begin the clinical trial after obtaining approval for\nthe trial by one or more IRBs without separate approval from the FDA, but must still follow abbreviated IDE requirements, such as monitoring\nthe investigation, ensuring that the investigators obtain informed consent, and labeling and record-keeping requirements. Acceptance\nof an IDE application for review does not guarantee that the FDA will allow the IDE to become effective and, if it does become effective,\nthe FDA may or may not determine that the data derived from the trials support the safety and effectiveness of the device or warrant\nthe continuation of clinical trials. An IDE supplement must be submitted to, and approved by, the FDA before a sponsor or investigator\nmay make a change to the investigational plan that may affect its scientific soundness, study plan or the rights, safety or welfare of\nhuman subjects. During a study, the sponsor is required to comply with the applicable FDA requirements, including, for example, trial\nmonitoring, selecting clinical investigators and providing them with the investigational plan, ensuring IRB review, adverse event reporting,\nrecord keeping and prohibitions on the promotion of investigational devices or on making safety or effectiveness claims for them. The\nclinical investigators in the clinical study are also subject to FDA’s regulations and must obtain patient informed consent, rigorously\nfollow the investigational plan and study protocol, control the disposition of the investigational device, and comply with all reporting\nand recordkeeping requirements. Additionally, after a trial begins, we, the FDA or the IRB could suspend or terminate a clinical trial\nat any time for various reasons, including, but not limited to, the following:\n\n \n\n \n●\nThe\nFDA or other regulatory authorities do not approve a clinical trial protocol or a clinical trial, or place a clinical trial on hold;\n\n \n●\nPatients\ndo not enroll in clinical trials at the rate expected;\n\n \n●\nPatients\ndo not comply with trial protocols;\n\n \n●\nPatient\nfollow-up is not at the rate expected;\n\n \n●\nPatients\nexperience adverse events;\n\n \n●\nPatients\ndie during a clinical trial, even though their death may not be related to the products that are part of the trial;\n\n \n●\nDevice\nmalfunctions occur with unexpected frequency or potential adverse consequences;\n\n \n●\nSide\neffects or device malfunctions of similar products already in the market that change the FDA’s view toward approval of new\nor similar PMAs or result in the imposition of new requirements or testing; and\n\n \n●\nInstitutional\nreview boards and third-party clinical investigators may delay or reject the trial protocol.\n\n \n\n*510(k)\nClearance Process*\n\n \n\nUnder\nthe 510(k) process, the manufacturer must submit to the FDA a premarket notification submission demonstrating that the proposed device\nis “substantially equivalent, “as defined in the FDCA, to a legally marketed predicate device. A predicate device is a legally\nmarketed device that is not subject to premarket approval, i.e., a device that was legally marketed prior to May 28, 1976 (pre-amendments\ndevice) and for which a PMA is not required, a device that has been reclassified from Class III to Class II or I, or a device that was\nfound substantially equivalent through the 510(k) process.\n\n \n\nA\ndevice is considered to be substantially equivalent if, with respect to the predicate device, it has the same intended use and has either\n(i) the same technological characteristics; or (ii) different technological characteristics, but the information provided in the 510(k)\nsubmission demonstrates that the device does not raise different questions of safety or effectiveness than the predicate device.\n\n \n\nBefore\nthe FDA will accept a 510(k) premarket notification for substantive review, the FDA will first assess whether the submission satisfies\na minimum threshold of acceptability. If the FDA determines that the 510(k) submission lacks necessary information for substantive review,\nthe FDA will issue a “Refuse to Accept” letter which generally outlines the information the FDA believes is necessary to\npermit a substantive review and to reach a determination regarding substantial equivalence. An applicant must submit the requested information\nbefore the FDA will proceed with additional review of the submission. If a 510(k) submission is accepted for substantive review, the\nMedical Device User Fee Amendments sets a performance goal of 90 days for FDA review of a 510(k) submission, but the review time can\nbe delayed if FDA raises questions or requests addition information during the review process. As a practical matter, clearance often\ntakes longer, and clearance is never assured. Thus, as a practical matter, clearance often takes longer than 90 days. Although many 510(k)\npremarket notifications are cleared without clinical data, the FDA may require further information, including clinical data, to make\na determination regarding substantial equivalence, which may significantly prolong the review process. If the FDA agrees that the device\nis substantially equivalent, it will grant clearance to commercially market the device.\n\n \n\n69\n\n \n\n \n\nIf\nthe FDA determines that the device is substantially equivalent to a predicate device, it will grant 510(k) clearance to commercially\nmarket the device. If the FDA determines that the device is “not substantially equivalent” to a previously cleared device,\nthe device is automatically designated as a Class III device. The device sponsor must then fulfill more rigorous requirements of the\nPMA approval process or can request a risk-based classification determination for the device in accordance with the “de novo”\nprocess, which is a route to market for certain novel medical devices that are low to moderate risk and are not substantially equivalent\nto a predicate device.\n\n \n\nMedical\ndevices can only be marketed for the indications for use for which they are cleared or approved. After a device receives 510(k) clearance,\nany modification that could significantly affect its safety or effectiveness, or that would constitute a major change or modification\nin its intended use, will require a new 510(k) clearance or, depending on the modification, PMA approval or de novo reclassification.\nThe FDA requires each manufacturer to determine whether the proposed change requires submission of a 510(k), de novo request or a PMA\nin the first instance, but the FDA may review this determination to evaluate the regulatory status of the modified product at any time\nand may require the manufacturer to cease marketing and/or request the recall of the modified device until 510(k) marketing clearance\nor PMA approval is obtained or a de novo request is granted. Also, in these circumstances, the manufacturer may be subject to significant\nregulatory fines or penalties.\n\n \n\n*PMA\nApproval Process*\n\n \n\nClass\nIII devices require PMA approval before they can be marketed, although some pre-amendment Class III devices for which FDA has not yet\nrequired a PMA are cleared through the 510(k) process. The PMA process is more demanding than the 510(k) premarket notification process.\nIn a PMA, the manufacturer must demonstrate that the device is safe and effective for its intended use, and the PMA must be supported\nby extensive data, including data from preclinical studies and human clinical trials. The PMA must also contain a full description of\nthe device and its components, a full description of the methods, facilities, and controls used for manufacturing, and proposed labeling.\nFollowing receipt of a PMA, the FDA conducts an administrative review to determine whether the application is sufficiently complete to\npermit a substantive review. If it is not, the agency will refuse to file the PMA. If the FDA accepts the application for substantive\nreview, it has 180 days under the FDCA to complete its review of a filed PMA application, although in practice, the FDA’s review\noften takes significantly longer, and can take up to several years. During this review period, the FDA may request additional information\nor clarification of information already provided, and the FDA may issue a major deficiency letter to the applicant, requesting the applicant’s\nresponse to deficiencies communicated by the FDA. The FDA considers a PMA or PMA supplement to have been voluntarily withdrawn if an\napplicant fails to respond to an FDA request for information (e.g., major deficiency letter) within a total of 360 days. Before approving\nor denying a PMA application, an advisory panel of experts from outside the FDA may be convened to review and evaluate the application\nand provide recommendations to the FDA as to whether the FDA should approve the submission, approve it with specific conditions, or not\napprove it. The FDA may or may not accept the panel’s recommendation. Prior to approval of a PMA, the FDA may conduct inspections\nof the clinical trial data and clinical trial sites, as well as conduct inspections of the applicant or its third-party manufacturers\n‘or suppliers ‘manufacturing facility or facilities to, among other things, ensure compliance with the QSR.\n\n \n\nIf\nthe FDA evaluation of a PMA is favorable, the FDA will issue either an approval letter, or an approvable letter, the latter of which\nusually contains a number of conditions that must be met in order to secure final approval of the PMA. When and if those conditions have\nbeen fulfilled to the satisfaction of the FDA, the agency will issue a PMA approval letter authorizing commercial marketing of the device,\nsubject to the conditions of approval and the limitations established in the approval letter. The FDA may approve a PMA with post-approval\nconditions intended to ensure the safety and effectiveness of the device, including, among other things, restrictions on labeling, promotion,\nsale and distribution, and collection of long-term follow-up data from patients in the clinical study that supported PMA approval or\nrequirements to conduct additional clinical studies post-approval.\n\n \n\n70\n\n \n\n \n\n*Ongoing\nRegulation by the FDA*\n\n \n\nEven\nafter the FDA permits a device to be marketed, numerous and pervasive regulatory requirements continue to apply. These include:\n\n \n\n \n●\nEstablishment\nregistration and device listing with the FDA;\n\n \n \n \n\n \n●\nQSR\nrequirements, which require manufacturers, including third-party manufacturers, to follow stringent design, testing, control, supplier/contractor\nselection, compliant handling, documentation and other quality assurance procedures during all aspects of the design and manufacturing\nprocess;\n\n \n \n \n\n \n●\nLabeling\nregulations, advertising and promotion requirements, restrictions on sale, distribution or sale of a device, each including the FDA\nprohibition against the promotion of products for any uses other than those authorized by the FDA, which are commonly known as “off-label”\nuses;\n\n \n \n \n\n \n●\nThe\nMedical Device Reporting, or MDR, regulations, which require that a manufacturer report to the FDA if a device it markets may have\ncaused or contributed to a death or serious injury, or has malfunctioned and the device or a similar device that it markets would\nbe likely to cause or contribute to a death or serious injury, if the malfunction were to recur;\n\n \n\n \n●\nMedical\ndevice correction and removal reporting regulations, which require that manufacturers report to the FDA field corrections or removals\nif undertaken to reduce a risk to health posed by the device or to remedy a violation of the FDCA that may present a risk to health;\n\n \n \n \n\n \n●\nRecall\nrequirements, including a mandatory recall if there is a reasonable probability that the device would cause serious adverse health\nconsequences or death;\n\n \n \n \n\n \n●\nAn\norder of repair, replacement, or refund;\n\n \n \n \n\n \n●\nDevice\ntracking requirements; and\n\n \n \n \n\n \n●\nPost-market\nstudy and surveillance requirements.、\n\n \n\nAfter\na device receives 510(k) clearance, any modification that could significantly affects its safety or effectiveness, or that would constitute\na major change in its intended use, will require a new 510(k) or possibly a PMA. The FDA requires each manufacturer to make this determination\ninitially, but the FDA can review any such decision and can disagree with a manufacturer’s determination. If the FDA disagrees\nwith our determination not to seek a new 510(k) clearance, the FDA may retroactively require us to seek 510(k) clearance or possibly\na PMA. The FDA could also require us to cease marketing and distribution and/or recall the modified device until 510(k) clearance or\na PMA is obtained. Also, in these circumstances, we may be subject to significant regulatory fines and penalties. Some changes to an\napproved PMA device, including changes in indications, labeling, or manufacturing processes or facilities, require submission and FDA\napproval of a new PMA application or PMA supplement, as appropriate, before the change can be implemented. Supplements to a PMA often\nrequire the submission of the same type of information required for an original PMA application, except that the supplement is generally\nlimited to that information needed to support the proposed change from the device covered by the original PMA. The FDA uses the same\nprocedures and actions in reviewing PMA supplements as it does in reviewing original PMA applications.\n\n \n\nFDA\nregulations require us to register as a medical device manufacturer with the FDA. Additionally, some states also require medical device\nmanufacturers and/or distributors doing business within the state to register with the state or apply for a state license, which could\nsubject our facility to state inspection as well as FDA inspection on a routine basis for compliance with the QSR and any applicable\nstate requirements. These regulations require that we manufacture our products and maintain related documentation in a prescribed manner\nwith respect to manufacturing, testing and control activities.\n\n \n\nManufacturing\nprocesses for medical devices are required to comply with the applicable portions of the QSR, which cover the methods and the facilities\nand controls for the design, manufacture, testing, production, processes, controls, quality assurance, labeling, packaging, distribution,\ninstallation and servicing of finished devices intended for human use. The QSR also requires, among other things, maintenance of a device\nmaster file, device history file, and complaint files. As a manufacturer, we are subject to periodic scheduled or unscheduled inspections\nby the FDA. Failure to maintain compliance with the QSR requirements could result in the shutdown of, or restrictions on, manufacturing\noperations and the recall or seizure of marketed products, which would have a material adverse effect on our business. The discovery\nof previously unknown problems with any of our products, including unanticipated adverse events or adverse events of increasing severity\nor frequency, whether resulting from the use of the device within the scope of its clearance or off-label by a physician in the practice\nof medicine, could result in restrictions on the device, including the removal of the product from the market or voluntary or mandatory\ndevice recalls.\n\n \n\n71\n\n \n\n \n\nThe\nFDA has broad regulatory compliance and enforcement powers. If the FDA determines that a manufacturer has failed to comply with applicable\nregulatory requirements, it can take a variety of compliance or enforcement actions, which may result in any of the following sanctions:\n\n \n\n \n●\nRefusing\nor delays in processing, clearing, or approving submissions or applications for new products or modifications to existing products;\n\n \n \n \n\n \n●\nSuspension\nor withdrawal of 510(k) clearances or PMA approvals that have already been granted;\n\n \n \n \n\n \n●\nFDA\nrefusal to issue certification to foreign governments needed to export our products for sale in other countries;\n\n \n \n \n\n \n●\nCriminal\nprosecution;\n\n \n \n \n\n \n●\nWarning\nletters, untitled letters, fines, injunctions, consent decrees and civil penalties;\n\n \n \n \n\n \n●\nRecalls,\nwithdrawals, or administrative detention or seizure of our products; or\n\n \n \n \n\n \n●\nOperating\nrestrictions or partial suspension or total shutdown of production;\n\n \n\nFailure\nto comply with the applicable United States medical device regulatory requirements could result in, among other things, warning letters,\nuntitled letters, fines, injunctions, consent decrees, civil penalties, unanticipated expenditures, repairs, replacements, refunds, recalls\nor seizures of products, operating restrictions, total or partial suspension of production, the FDA’s refusal to issue certificates\nto foreign governments needed to export products for sale in other countries, the FDA’s refusal to grant future premarket clearances\nor approvals, withdrawals or suspensions of current product clearances or approvals and criminal prosecution.\n\n \n\n**Mainland\nChina**\n\n  \n\n*Supervision\nover Medical Devices and their Classification*\n\n \n\nThe\nmain regulatory authorities of mainland China’s medical device industry include the State Administration for Market Regulation,\nor SAMR, the National Medical Products Administration, formerly the China Food and Drug Administration, or CFDA, the National Development\nand Reform Commission, or NDRC, the National Health Commission, or NHC, and the National Healthcare Security Administration, or NHSA.\n\n \n\nThe\nRegulations on the Supervision and Administration of Medical Devices, or the Regulations on Medical Devices, as amended by the State\nCouncil on February 9, 2021 and became effective on June 1, 2021, regulates entities that engage in the R&D, production, operation,\nuse, supervision and administration of medical devices in mainland China. Medical devices are classified according to their risk levels.\nClass I medical devices are medical devices with low risks, and the safety and effectiveness of which can be ensured through routine\nadministration. Class II medical devices are medical devices with moderate risks, which are strictly controlled and administered to ensure\ntheir safety and effectiveness. Class III medical devices are medical devices with relatively high risks, which are strictly controlled\nand regulated through special measures to ensure their safety and effectiveness.\n\n \n\nThe\nevaluation of the risk levels of medical devices takes into consideration the medical devices’ objectives, structural features,\nmethods of use and other factors. Registration is required for Class II and Class III medical devices; and filing is required for Class\nI medical devices. Furthermore, to engage in the business operator of Class II medical devices, the operator shall file for record with\nthe authority department; and to engage in the production of Class II or Class III medical devices, the producer shall procure a permission\nwith the authority department; while to engage in the production of Class I medical devices, the producer shall file for record with\nthe authority department. Violations of the Regulations on Medical Devices shall result in various penalties ranging from fines (fixed\nrange or based on the values of the illegally manufactured goods in severe violations), confiscation of products illegally sold and illegally\nobtained gains, revoking licenses, suspension of business, being refused to review and approve the medical devices permit within five\nyears after such violation, or even criminal liability.\n\n \n\n*Registration\nand Filing of Medical Device Products*\n\n \n\nPursuant\nto the Measures for the Administration of Registration and Filing of Medical Devices, which were promulgated by the SAMR on August 26,\n2021 and came into effect on October 1, 2021, Class I medical devices shall be subject to product filing, while Class II and Class III\nmedical devices shall be subject to product registration. For Class I domestic medical devices, the applicant shall submit filing materials\nto the medical products administrative departments at the level of cities divided into districts. For Class II domestic medical devices,\nthe medical products administrative departments of provinces, autonomous regions and municipalities directly under the Central Government\nshall be responsible for examination, and issuance of registration certificates for medical devices. For Class III domestic medical devices,\nthe NMPA shall be responsible for examination, and issuance of registration certificates for medical devices. For Class I imported medical\ndevices, applicant shall submit filing materials to the NMPA. In addition, the Measures for the Administration of Registration and Filing\nof Medical Devices also sets out provisions on R&D, clinical evaluation, verification of the registration system, product registration,\nchange of registration, renewal of registration and filing of medical devices.\n\n \n\n72\n\n \n\n \n\nA\nregistrant shall proactively carry out post-marketing research on a medical device to further confirm the safety, effectiveness and quality\ncontrol of a medical device, and strengthen the management of the listed medical device. For registered Class II and Class III medical\ndevices, if there are any substantial changes in the design, raw materials, production techniques, applicable scope and usage, among\nothers which may impact its safety and effectiveness, the registrants shall apply to the original registration departments to modify\nits registration; for other changes, registrants shall file the modifications with the original registration departments within 30 days\nfrom the date of the changes.\n\n \n\nThe\nGood Clinical Practice for Medical Devices Trials promulgated by the NMPA and the NHC, which was last amended on March 24, 2022 and became\neffective on May 1, 2022 stipulates the procedural requirements for medical device clinical trials, including, among others, the protocol\ndesign, implementation, monitoring, verification, inspection, and data collection, recording, preservation, analysis, summary and reporting\nprocedure of a clinical trial. When conducting clinical trials for medical devices, an applicant shall formulate scientific and reasonable\nclinical trial protocols according to the purpose of the trial, and consider comprehensively the risks, technical characteristics, scope\nof application and expected use of the medical devices. The applicant shall select appropriate and qualified clinical trial institutions\nand researchers according to the medical device, and enter into a contract with them to specify the rights and obligations of each party\nin the clinical trials of medical devices. The applicant for clinical trials of medical devices shall be responsible for initiating,\napplying, organizing and monitoring such clinical trials, and shall be responsible for the authenticity and compliance of the clinical\ntrials.\n\n \n\n*Regulations\nRegarding the Production of Medical Devices*\n\n \n\nPursuant\nto the Regulations on Medical Devices, in addition to the medical device registration certificate, the medical device manufacturers shall\nfile with the local NMPA at the municipal level or obtain a production license from the local NMPA at the provincial level before engaging\nin the production of medical devices. A medical device production license shall be valid for five years. The Measures for the Supervision\nand Administration of Medical Device Manufacture, was promulgated by the CFDA on July 20, 2004 and was last amended on March 10, 2022,\nwhich became effective on May 1, 2022, pursuant to which, in the event of entrusted manufacturing of medical devices, the medical devices\nregistrant or the party undergoing filing shall assess the entrusted party’s quality assurance capabilities and risk management\ncapabilities, and follow the guidelines for entrusted production to sign the quality agreement and the entrustment agreement with the\nentrusted party and to supervise the entrusted party to fulfill the obligations agreed upon in the agreement.\n\n \n\nPursuant\nto the Good Manufacturing Practice for Medical Devices, which was promulgated on December 29, 2014 and became effective on March 1, 2015,\nan enterprise engaging in the production of medical devices shall establish and maintain an effective quality control system in accordance\nwith the requirements of the Good Manufacturing Practice for Medical Devices. The regulations set provisions on the organization and\npersonnel, premises and facilities, equipment, document management, design and development, purchasing, production management, quality\ncontrol, sales and after-sale services of medical devices. The enterprise shall establish a procurement control process and evaluate\nits suppliers by establishing an examination system to ensure the purchased products are in compliance with the statutory requirements.\nThe enterprise shall implement risk management procedures to the entire process from design and development, production, sales and after-sale\nservices, and the measures taken shall be appropriate to the risks of the products.\n\n \n\n*Regulation\nRegarding the Operation of Medical Devices*\n\n \n\nAccording\nto the Administrative Measures for Supervision of the Operation of Medical Devices, which was promulgated by the CFDA on July 30, 2014\nand was later amended on November 17, 2017, and March 10, 2022, which became effective on May 1, 2022, pursuant to which, an enterprise\nengaging in the operations of Class I medical devices is not required to obtain an approval or filing. An enterprise engaging in the\noperations of Class II medical devices is required to obtain a product filing with the food and drug supervision and administration departments\nof the city with districts where it is located. An enterprise engaging in the operations of Class III medical devices shall obtain an\noperation permit from the food and drug supervision and administration departments of the city with districts where it is located. No\noperation permit or filing is required for the registrant, record holder or manufacturer to sell its medical devices at its domicile\nor production sites; while an operation permit or filing is required to store and sell medical devices in other places.\n\n \n\n*Regulations\nRegarding the Naming and Labeling of Medical Devices*\n\n \n\nIn\naccordance with the Provisions on the Administration of Instructions and Labels of Medical Devices adopted at the executive meeting of\nthe CFDA on June 27, 2014 and implemented on October 1, 2014, the contents in the instructions and labels of medical devices shall be\nscientific, true, complete, accurate and consistent with product features. Where the instructions and labels fail to meet the requirements\nset out in the provisions, the food and drug supervision and administration department at or above the county level shall impose penalties\nin accordance with Article 67 of the Regulation of Medical Devices.\n\n \n\n73\n\n \n\n \n\nThe\nNaming Rules for the Generic Names of Medical Devices was promulgated by the CFDA and became effective from April 1, 2016. For purposes\nof strengthening the supervision and administration of medical devices and guaranteeing that generic names of medical devices are named\nin a scientific and standardized manner, the Naming Rules for the Generic Names of Medical Devices stipulates that medical devices sold\nand used within the territory of mainland China shall have a generic name.\n\n \n\n*Regulations\nRegarding the Safety Control of Medical Devices*\n\n \n\nPursuant\nto the Administrative Measures for Medical Device Recalls, which was promulgated by the former CFDA on January 25, 2017 and became effective\non May 1, 2017, medical device manufacturers are responsible for reducing and eliminating product defects, and voluntarily recalling\nany defective products. Defective medical devices include products (i) that would cause unreasonable risk to human health and life during\nthe normal use; (ii) that do not conform to the required standards, or the technical requirements stipulated on the product registration\nor filing; (iii) that do not comply with relevant quality management requirements on the production and operation of medical devices\nand may cause unreasonable risk; and (iv) that need to be recalled.\n\n \n\nAs\ndefects may cause severe consequences, medical device recalls are divided into three classes, namely: (i) Class I recall, where the circumstances\nleading to the recall may cause, or have caused, serious harm to health; (ii) Class II recall, where the circumstances leading to the\nrecall may cause, or have caused, temporary or reversible harm to health; or (iii) Class III recall, where the circumstances leading\nto the recall are not likely to cause harm, but a recall is necessary.\n\n \n\nMedical\ndevice manufacturers shall determine the appropriate recall class based on the situation and design and implement an appropriate recall\nplan by taking into consideration the recall class and the sale and use of the medical devices. For Class I recalls, the recall notice\nshall be published on the NMPA website and major media channels of the central government. For Class II and Class III recalls, the recall\nnotice shall be published on the website of the provincial level, autonomous regions or municipalities of food and drug administrative\nauthority.\n\n \n\nIn\naccordance with the Administration Measures for Medical Device Adverse Events Monitoring and Re-evaluation which was issued on August\n13, 2018 and became effective on January 1, 2019, the holder of the medical device registration certificate is obliged to collect information\nwith respect to adverse events and report to the monitoring technical regulators in a timely manner. The adverse events are classified\nas individual medical device adverse events and group medical device adverse events. In the event an individual medical device adverse\nevent occurs, the holder is required to conduct an investigation immediately and report its findings within seven days if a death has\noccurred or within 20 days if a serious injury, possible serious injury or possible death has occurred. In the event a group medical\ndevice adverse event occurs, the holder, business operator or user aware of the group medical device adverse event shall report to the\ncompetent regulatory authorities within 12 hours.\n\n \n\n**Hong\nKong**  \n\n \n\nCurrently,\nthere is no specific legislation that regulates the manufacture, import, export and sale of medical devices in Hong Kong. However, depending\non the nature and characteristics of the products concerned, some products may be regulated by existing pieces of legislation such as\nthe Pharmacy and Poisons Ordinance (Cap 138), the Radiation Ordinance (Cap 303), and the Telecommunications Ordinance (Cap 106).\n\n \n\nA\nstatutory control framework for medical devices is being developed by the Hong Kong government to ensure that medical devices are safe,\nof good quality, and can perform as intended before they are allowed to be placed on the local market. To raise public awareness on the\nsafe use of medical devices and enable traders to familiarize themselves with the future mandatory requirements, the Government has launched\nthe voluntary Medical Device Administrative Control System (MDACS) since November 2004. The listing of medical devices and traders, and\nthe Conformity Assessment Body (CAB) Recognition Scheme were implemented in phases. The MDACS covers classes II to IV (medium to high\nrisk) general medical devices, classes B to D (medium to high risk) in vitro diagnostic medical devices, local manufacturers, importers,\ndistributors and CABs. The MDACS has the same scope as that of the proposed legislative control framework.\n\n \n\n74\n\n \n\n \n\n**Laws\nand Regulations Relating to Our Business in Singapore**\n\n \n\nAs\nwe operate primarily in Singapore, we are subject to all relevant laws and regulations of Singapore and may be affected by new laws,\nregulations and policies which are introduced by the Singapore government from time to time. We have identified the main laws and regulations\n(apart from those pertaining to general business requirements) that we anticipate may materially affect our operations, the relevant\nregulatory bodies and the licenses, permits and approvals typically required for the conduct of our business in Singapore.\n\n \n\nThe\nfollowing description is a summary of material laws and regulations applicable to our operations in Singapore. The laws and regulations\nset out below are not exhaustive and are only intended to provide general information to investors and are neither designed nor intended\nto be a substitute for professional advice. Prospective investors should consult their own advisers regarding the implication of the\nrelevant laws and regulations on us.\n\n \n\n**Regulations\non Labor**\n\n \n\n*Employment\nAct*\n\n \n\nThe\nEmployment Act 1968 of Singapore (the “Employment Act”) is the main legislation governing employment in Singapore and is\nadministered by the Ministry of Manpower (“MOM”). The Employment Act covers every employee who is under a contract of service\nwith an employer (which includes workmen and persons employed in managerial or executive positions but does not cover seafarers, domestic\nworkers, and, under certain circumstances persons employed in a managerial or executive position. The definition of “employee”\nunder the Employment Act does not extend to freelance contractors who have entered into a contract for service.\n\n \n\nA\nworkman is defined under the Employment Act as including, among others, (a) any person, skilled or unskilled, who has entered into a\ncontract of service with an employer in pursuance of which he is engaged in manual labor, including any apprentice but excluding any\nseafarer or domestic worker; and (b) any person employed partly for manual labor and partly for the purpose of supervising in person\nany workman in and throughout the performance of his work.\n\n \n\nCore\nemployment provisions of the Employment Act, such as public holiday and sick leave entitlements, minimum days of annual leave, payment\nof salary and authorized deductions and reinstatement for wrongful dismissal, cover all employees (as defined in the Employment Act).\n\n \n\nIn\naddition to the core employment provisions of the Employment Act, Part 4 of the Employment Act contains provisions relating to, among\nother things, working hours, overtime, rest days, payment of retrenchment benefit, priority of retirement benefit, annual wage supplements\nand other conditions of work or service (“Part 4”). However, such Part 4 provisions only apply to: (a) workmen earning basic\nmonthly salaries of not more than S$4,500; and (b) employees (excluding workmen or a person employed in a managerial or an executive\nposition) earning basic monthly salaries of not more than S$2,600. An employer who breaches any provision of Part 4 is guilty of an offence\nand is liable on conviction for a fine not exceeding S$5,000, and for a second or subsequent offence a fine not exceeding S$10,000 or\nimprisonment for a term not exceeding 12 months or both.\n\n \n\nEmployers\nare required to provide to their employees who are covered by the Employment Act and who have entered into a contract of service with\nthe employer on or after 1 April 2016, and are employed for a continuous period of 14 days or more, a written record of the key employment\nterms of the employee. The key employment terms required to be provided (unless inapplicable to such employee) include, among other things,\nworking arrangements (such as daily working hours, number of working days per week and rest day(s)), salary period, basic salary, fixed\nallowances and deductions, overtime rate of pay, types of leave and other medical benefits.\n\n \n\n*Employment\nof Foreign Manpower Act*\n\n \n\nThe\nemployment of foreign employees in Singapore is governed by the Employment of Foreign Manpower Act 1990 of Singapore (the “EFMA”)\nand is regulated by the MOM. The EFMA prescribes the responsibilities and obligations of employers of foreign employees in Singapore.\n\n \n\nThe\nEFMA provides that no person shall employ a foreign employee unless the foreign employee has obtained a valid work pass from the MOM\nin accordance with the Employment of Foreign Manpower (Work Passes) Regulations 2012, which allows the foreign employee to work for him.\nAny person who fails to comply with or contravenes this provision of the EFMA is guilty of an offence and will: (a) be liable on conviction\nfor a fine not less than S$5,000 and not more than S$30,000 or imprisonment for a term not exceeding 12 months or both; and (b) on a\nsecond or subsequent conviction: (i) in the case of an individual, be liable for a fine of not less than S$10,000 and not more than S$30,000\nand imprisonment for a term of not less than one month and not more than 12 months; or (ii) in any other case, be punished with a fine\nof not less than S$20,000 and not more than S$60,000.\n\n \n\n75\n\n \n\n \n\n**Regulations\non Provident Fund**\n\n \n\n*Central\nProvident Fund Act*\n\n \n\nThe\nCentral Provident Fund (the “CPF”) system is a mandatory social security savings scheme funded by contributions from employers\nand employees. Pursuant to the Central Provident Fund Act 1953 of Singapore (“CPFA”), an employer is obliged to make CPF\ncontributions for all employees who are Singapore citizens or permanent residents who are employed in Singapore by an employer (which\ndo not include those who are employed as a master, a seaman or an apprentice in any vessel, subject to an exception for non-exempted\nowners). However, CPF contributions do not apply to employees who are not a citizen or permanent resident of Singapore. CPF contributions\nare required for both ordinary wages and additional wages (subject to an ordinary wage ceiling and an additional wage ceiling) of employees\nat the applicable prescribed rates which is dependent on, among other things, the amount of monthly wages and the age of the employee.\nEmployers must pay both the employer’s and employee’s share of the monthly CPF contribution. However, an employer can recover\nthe employee’s share of CPF contributions by deducting it from their wages when the contributions are paid for that month.\n\n \n\nWhere\nthe amount of the contributions which an employer is liable to pay under the CPFA in respect of any month is not paid within such period\nas may be prescribed, the employer shall be liable for the payment of interest on the amount for every day the amount remains unpaid\ncommencing from the first day of the month succeeding the month in respect of which the amount is payable and the interest shall be calculated\nat the rate of 1.5% per month or the sum of S$5, whichever is greater. Additionally, where any employer who has recovered any amount\nfrom the monthly wages of an employee in accordance with the CPFA fails to pay the contributions to the CPF within such time as may be\nprescribed, he will be guilty of an offence and will be liable on conviction for a fine not exceeding S$10,000 or imprisonment for a\nterm not exceeding seven years or both. Lastly, where a person has been convicted of an offence under the CPFA but there are no penalties\nprovided, the offender may be liable for a fine not exceeding S$5,000 or imprisonment for a term not exceeding six months or both, and\nwhere the offence is repeated by the same offender, the offender may be liable for a fine not exceeding S$10,000 or imprisonment for\na term not exceeding 12 months or both.\n\n \n\n**Regulations\non Import and Export**\n\n \n\n*Customs\nRegulations*\n\n \n\nGoods\nexported from, or imported into, Singapore are regulated under the Customs Act 1960 of Singapore (the “Customs Act”). To\nexport goods from, or import goods into, Singapore, the exporter or importer (as the case may be) is required to declare the goods to\nSingapore Customs, a department under the Ministry of Finance, which is the lead agency for trade facilitation and revenue enforcement.\nGoods and services tax (“GST”) is not levied on goods exported from Singapore. A customs export permit is required for, among\nother things, the export of locally manufactured goods or local GST paid goods, the export of goods from free trade zones, dutiable goods\nfrom licensed warehouses and non-dutiable goods from a zero-rated warehouse. A customs import permit is required for the import of goods\ninto Singapore.\n\n \n\nExporters\nand importers may be penalized if they do not comply with the requirements and conditions imposed under the Customs Act. A person who\nmakes an incorrect declaration or fails to make a declaration of goods imported into, exported from or transshipped in Singapore may\nbe liable on conviction for a fine not exceeding S$10,000, or the equivalent of the amount of the customs duty, excise duty or tax payable,\nwhichever is the greater amount, or imprisonment for a term not exceeding 12 months, or both.\n\n \n\n**Regulations\non Workplace Safety and Health**\n\n \n\n*Workplace\nSafety and Health Act 2006*\n\n \n\nThe\nWorkplace Safety and Health Act 2006 of Singapore (“WSHA”), which is regulated by the MOM, provides that every employer has\nthe duty to take, so far as is reasonably practicable, such measures as are necessary to ensure the safety and health of its employees\nat work. These measures include: (a) providing and maintaining for the employees a work environment that is safe, without risk to health,\nand adequate as regards to facilities and arrangements for employees’ welfare at work; (b) ensuring that adequate safety measures\nare taken in respect of any machinery, equipment, plant, article or process used by the employees; (c) ensuring that the employees are\nnot exposed to hazards arising out of the arrangement, disposal, manipulation, organization, processing, storage, transport, working\nor use of things in or near their workplace and under the control of the employer; (d) developing and implementing procedures for dealing\nwith emergencies that may arise while those persons are at work; and (e) ensuring that the employees at work have adequate instruction,\ninformation, training and supervision as is necessary for them to perform their work.\n\n \n\n76\n\n \n\n \n\nAny\nperson who breaches his duty under the WSHA is guilty of an offence and will be liable on conviction, in the case of a body corporate,\nto a fine not exceeding S$500,000 and if the contravention continues after the conviction, the body corporate shall be guilty of a further\noffence and will be liable to a fine not exceeding S$5,000 for every day or part thereof during which the offence continues after conviction.\nFor repeat offenders, where a person has on at least one previous occasion been convicted of an offence under the WSHA that causes the\ndeath of any person and that person is subsequently convicted of the same offence that causes the death of another person, the court\nmay, in addition to any imprisonment, if prescribed, punish the person, in the case of a body corporate, with a fine not exceeding S$1\nmillion and, in the case of a continuing offence, with a further fine not exceeding S$5,000 for every day or part thereof during which\nthe offence continues after conviction.\n\n \n\nUnder\nthe WSHA, it is the duty of any person who manufactures any machinery, equipment or hazardous substance (“MEHS”) for use\nat work to ensure, so far as is reasonably practicable, that (a) information regarding the safe use of the MEHS is available to any person\nto whom the MEHS is supplied for use at work (which should include precautions to be taken for the proper use and maintenance of such\nMEHS, the health hazards associated with the MEHS and the information relating to and the results of any examinations or tests of the\nMEHS that are relevant to its safe use); (b) the MEHS are safe, and without risk to health, when properly used; and (c) the MEHS are\nexamined and tested in compliance with the obligation imposed by paragraph (b). The duties imposed on any person in respect of the aforementioned\nshall (i) apply only if the MEHS are manufactured or supplied in the course of a trade, business, profession or undertaking carried on\nby the person (whether for profit or not); (ii) apply whether the MEHS are exclusively manufactured or supplied for use by persons at\nwork; (iii) extend to the supply of the MEHS by way of sale, transfer, lease or hire and whether as principal or agent, and to the supply\nof the MEHS to a person for the purpose of supply to others; and (iv) not apply to a person by reason only that the person supplies the\nmachinery or equipment under a lease-purchase agreement, conditional sale agreement or credit-sale agreement to another (the “Customer”)\nin the course of a business of financing the acquisition of the machinery or equipment by the Customer from others. In the event any\nperson contravenes the relevant provision in the WSHA that imposes the aforementioned duty on such person, that person is guilty of an\noffence, and liable on conviction (in the case of a natural person) for a fine not exceeding S$200,000 or imprisonment for a term not\nexceeding two years or both, or (in the case of a body corporate) for a fine not exceeding S$500,000.\n\n \n\nFurther,\nthe Commissioner for Workplace Safety and Health (the “CWSH”) may serve a remedial order or a stop-work order in respect\nof a workplace if he is satisfied that (a) the workplace is in such condition, or is so located, or any part of the machinery, equipment,\nplant or article in the workplace is so used, that any work or process carried on in the workplace cannot be carried on with due regard\nto the safety, health and welfare of persons at work; (b) any person has contravened any duty imposed by the WSHA; or (c) any person\nhas done any act, or has refrained from doing any act which, in the opinion of the CWSH, poses or is likely to pose a risk to the safety,\nhealth and welfare of persons at work.\n\n \n\nA\nremedial order will direct the person served with the order to take such measures, to the satisfaction of the CWSH, to, among other things,\nremedy any danger so as to enable the work or process in the workplace to be carried on with due regard to the safety, health and welfare\nof the persons at work. A stop-work order will direct the person served with the order to immediately cease to carry on any work or process\nindefinitely or until such measures as are required by the CWSH have been taken, to the satisfaction of the CWSH, to remedy any danger\nso as to enable the work or process in the workplace to be carried on with due regard to the safety, health and welfare of the persons\nat work, and shall specify the date on which such order is to take effect.\n\n \n\nUnder\nthe WSHA, if the CWSH becomes aware of any accident, dangerous occurrence (such occurrences being set out in the First Schedule of the\nWSHA) or occupational disease (including the diseases set out in the Second Schedule of the WSHA) in a workplace, the Commissioner may\ndirect an inspector to investigate the circumstances of the accident, dangerous occurrence or occupational disease. The occupier of a\nworkplace in which an accident, a dangerous occurrence or occupational disease occurs must take all reasonable measures to prevent any\nperson from modifying the scene where any fatal accident, dangerous occurrence or occupational disease occurred.\n\n \n\nAdditionally,\nunder the WSHA, inspectors appointed by the CWSH may, among others, enter a workplace to make such examination and inquiry as may be\nnecessary to ascertain whether the provisions of the WSHA are complied with, to take samples of any material or substance found in a\nworkplace or being discharged from any workplace for the purpose of analysis or test, to assess the levels of noise, illumination, heat\nor harmful or hazardous substances in any workplace and the exposure levels of persons at work therein and to take into custody any article\nin a workplace which is relevant to an investigation or inquiry under the WSHA.\n\n \n\n*Workplace\nSafety and Health (Noise) Regulations 2011*\n\n \n\nPursuant\nto the Workplace Safety and Health (Noise) Regulations 2011 (the “WSH(N)R”), the occupier of a workplace must take reasonably\npracticable measures to reduce or control the noise from any machinery or equipment used or from any process, operation or work carried\nout by him in the workplace, so that no person at work in the workplace is exposed or likely to be exposed to excessive noise. This may\ninclude replacing noisy machinery, equipment, processes, operations or work with less noisy machinery, equipment, processes, operations\nor work, and such other measures as prescribed under the WSH(N)R. Where it is not practicable to reduce the noise, the occupier of a\nworkplace shall limit the duration of time persons at work are exposed to the noise in accordance with the time limits prescribed in\nthe Schedule under the WSH(N)R. Any person who contravenes the aforementioned is guilty of an offence and is liable on conviction for\na fine not exceeding S$20,000 or imprisonment for a term not exceeding two years or both, and if the person is a repeat offender, for\na fine not exceeding S$50,000 or imprisonment for a term not exceeding two years or both.\n\n \n\n77\n\n \n\n \n\n*Workplace\nSafety and Health (Risk Management) Regulations*\n\n \n\nPursuant\nto the Workplace Safety and Health (Risk Management) Regulations, the employer in a workplace is required to, among other things, conduct\na risk assessment in relation to the safety and health risks posed to any person who may be affected by his undertaking in the workplace,\ntake all reasonably practicable steps to eliminate or minimize foreseeable risks to any person who may be affected by his undertaking\nin the workplace, implement safe work procedures to control the risks, and to inform workers of the same, maintain records of such risk\nassessments and measures/safe work procedures for a period of not less than three years and submit such records to the CWSH when required\nby the CWSH from time to time. Any employer who, without reasonable excuse, contravenes the regulations pursuant to which the aforementioned\nrequirements are imposed, is guilty of an offence and is liable on conviction for, depending on the specific regulation contravened:\n(i) a fine not exceeding S$50,000 or imprisonment for a term not exceeding two years or both; (ii) a fine not exceeding S$20,000 or imprisonment\nfor a term not exceeding two years or both, and if the person is a repeat offender, for a fine not exceeding S$50,000 or imprisonment\nfor a term not exceeding two years or both; or (iii) a fine not exceeding S$10,000, and if the person is a repeat offender, for a fine\nnot exceeding S$20,000 or imprisonment for a term not exceeding six months or both.\n\n \n\n*Workplace\nSafety and Health (General Provisions) Regulations (“WSH(GP)R”)*\n\n \n\nMore\nspecific duties imposed on employers are laid out in the WSH(GP)R. Some of these duties include (a) taking effective measures to protect\npersons at work from the harmful effects of any exposure to any biohazardous material which may constitute a risk to their health; (b)\ntaking reasonably practicable measures to prevent the accumulation of any toxic dust, fumes, gas, vapor, mist, fiber or other contaminants;\n(c) providing, maintaining and keeping clean, sufficient and suitable sanitary conveniences for employees in the work place; and (d)\nproviding and maintaining sufficient and suitable lighting for such sanitary conveniences.\n\n \n\nIt\nis also mandatory for at least one board director or chief executive officer of our Singapore Subsidiary to complete the Top Executive\nWSH Programme, as the Singapore Subsidiary is in the manufacturing industry and the manufacturing industry is a high-risk industry according\nto the Singapore Standard Industrial Classification. The Singapore Subsidiary is therefore a regulated person (i.e., a person that carries\non a business in Singapore, the general nature of which is or includes a high-risk industry) under Regulation 38B of the WSH(GP)R. A\nregulated person that contravenes this requirement shall be guilty of an offence and shall be liable on conviction to a fine not exceeding\n$20,000 and, in the case of a continuing offence, to a further fine not exceeding $1,000 for every day or part of a day during which\nthe offence continues after conviction.\n\n \n\n*Work\nInjury Compensation Act*\n\n \n\nThe\nWork Injury Compensation Act 2019 of Singapore (“WICA”), which is regulated by the MOM, applies to all employees who have\nentered into or work under a contract of service (including an apprenticeship contract) with an employer. The WICA does not cover self-employed\npersons or independent contractors. However, the WICA does provide that, where any person (referred to as the principal) in the course\nof or for the purpose of his trade or business contracts with any other person (referred to as the subcontractor employer), the principal\nshall be liable to compensate those employees of the subcontractor employer who were injured while employed in the execution of work\nfor the principal where directed by the Commissioner. The WICA provides that if an employee dies or sustains personal injuries in a work-related\naccident or contracts occupational diseases in the course of the employment, the employer shall be liable to pay compensation in accordance\nwith the provisions of the WICA. An injured employee is entitled to claim medical leave wages, medical expenses and lump sum compensation\nfor permanent incapacity or death, subject to certain limits stipulated in the WICA.\n\n \n\nUnder\nthe WICA, every employer is required to insure and maintain insurance under approved policies with an insurer against all liabilities\nwhich he may incur under the provisions of the WICA in respect of all employees employed by him, unless specifically exempted. Failure\nto provide adequate insurance is an offence carrying a fine of up to S$10,000 or imprisonment for a term of up to 12 months, or both.\n\n \n\n78\n\n \n\n \n\n**Regulations\non Environmental Protection and Waste Disposal**\n\n \n\n*Environmental\nPublic Health Act 1987*\n\n \n\nAdministered\nby the NEA, the Environmental Public Health Act 1987 of Singapore (the “EPHA”) regulates, among other things, the disposal\nand treatment of industrial waste and public nuisances. The DGPH may, pursuant to the EPHA, upon receipt of any information with respect\nto the existence of a nuisance liable to be dealt with summarily under the EPHA and if satisfied of the existence of a nuisance, serve\na nuisance order, requiring measures to be taken to remedy the nuisance, on the person by whose act, default or sufferance the nuisance\narises or continues, or if the person cannot be found, on the owner or occupier of the premises on which the nuisance arises. Examples\nof the nuisances which may be liable to be dealt with summarily under the EPHA include (a) any factory or workplace which is not kept\nin a clean state; (b) any place where there exists or is likely to exist any condition giving rise, or capable of giving rise to the\nbreeding of flies or mosquitoes; (c) the keeping of any animal in such numbers as to become a nuisance; (d) any dust, effluvium, accumulation\nor deposit which is a nuisance or injurious or dangerous to health; or (e) the issue of any fumes, vapours, gases, heat, radiation or\nsmells in any premises which is a nuisance or injurious or dangerous to health. Any failure to comply with the nuisance order served\nis an offence and such person is liable upon first conviction to a fine not exceeding S$10,000 and to a further fine not exceeding S$1,000\nfor every day during which the offence continues after conviction.\n\n \n\nAdditionally,\nunder the EPHA, no person must dispose of or cause or permit to be disposed of industrial waste in or at any place except in or at a\npublic disposal facility or a disposal facility established pursuant to a waste disposal licence granted by the DPGH. Any failure to\ncomply with the aforementioned obligation under the EPHA concerning the disposal of industrial waste shall be guilty of an offence and\nshall be liable on first conviction to a fine not exceeding $10,000 or to imprisonment for a term not exceeding 12 months or to both.\n\n \n\nFurther,\nthe occupier of any work place where industrial waste is being produced must keep or store the waste before disposal in a proper and\nefficient manner so as not to create a nuisance or to cause any risk, harm or injury to persons or animals or is likely to pollute the\nenvironment. Any person who contravenes such provision shall be guilty of an offence and liable on first conviction to a fine not exceeding\n$5,000.\n\n \n\n*Environmental\nProtection and Management Act 1999*\n\n \n\nAdministered\nby the NEA, the Environmental Protection and Management Act 1999 of Singapore and its subsidiary legislation regulate, among other things,\nenvironmental pollution control in Singapore. Pursuant to the Environmental Protection and Management (Boundary Noise Limits for Factory\nPremises) Regulations (“EPM(BNLFP)R”), the owner or occupier of any factory premises shall ensure that the level of noise\nemitted from his premises does not exceed the maximum permissible noise levels as set out in the First Schedule to the EPM(BNLFP)R. The\nmaximum permissible noise levels may vary depending on the type of premise being so affected, such premises may include, among others,\nnoise sensitive premises that require peace and quiet, residential premises and commercial premises. Any person who fails to comply with\nthe aforementioned restrictions is guilty of an offence and liable upon conviction for (a) a fine not exceeding S$5,000 on the first\nconviction, and in the case of a continuing offence, to a further fine not exceeding S$200 for every day or part thereof the offence\ncontinues after the conviction; and (b) a fine not exceeding S$10,000 on a subsequent conviction, and in the case of a continuing offence,\nto a further fine not exceeding S$300 for every day or part thereof during which the offence continues after conviction.\n\n \n\n**Regulations\non Data Protection**\n\n \n\n*Data\nProtection Obligations*\n\n \n\nThe\nPersonal Data Protection Act 2012 of Singapore (“PDPA”) is a legal framework which establishes the Singapore regime for the\nprotection of personal data, and governs the collection, use and disclosure of personal data by organisations. In this regard, “personal\ndata” as defined under the PDPA refers to data, whether true or not, about an individual who can be identified from that data,\nor from that data and other information to which the organization has or is likely to have access.\n\n \n\nAn\norganization is required to comply with the following obligations imposed by the PDPA:\n\n \n\n(a)\n*Purpose limitation obligation*– personal data must be collected, used or disclosed only for purposes that a reasonable person\nwould consider appropriate in the circumstances, and if applicable, have been notified to the individual concerned;\n\n \n\n(b)\n*Notification obligation*– individuals must be notified of the purposes for the collection, use or disclosure of their personal\ndata before such collection, use or disclosure;\n\n \n\n(c)\n*Consent obligation*– the consent of individuals must be obtained for any collection, use or disclosure of their personal\ndata, unless collection, use or disclosure of personal data without the individual’s consent is required or authorized under the\nPDPA or other written law. In addition, an organization must allow the withdrawal of consent which has been given or is deemed to have\nbeen given;\n\n \n\n79\n\n \n\n \n\n(d)\n*Access and correction obligations*– when requested by an individual and unless exceptions under the PDPA apply, an organization\nmust: (i) provide that individual with access to his personal data in the possession or under the control of the organization and information\nabout the ways in which his personal data has been or may have been used or disclosed during the past year, and/or (ii) correct an error\nor omission in his personal data that is in the possession or under the control of the organization;\n\n \n\n(e)\n*Accuracy obligation*– an organization must make reasonable efforts to ensure that personal data collected by or on its behalf\nis accurate and complete if such personal data is likely to be used by the organization to make a decision affecting the individual to\nwhom the personal data relates or if such personal data is likely to be disclosed to another organization;\n\n \n\n(f)\n*Protection obligation*– an organization must make reasonable security arrangements for the protection of personal data in\nits possession or under its control;\n\n \n\n(g)\n*Retention limitation obligation*– an organization must not keep personal data for longer than it is necessary to fulfill:\n(i) the purpose for which it was collected, or (ii) a legal or business purpose;\n\n \n\n(h)\n*Transfer limitation obligation*– personal data must not be transferred out of Singapore except in accordance with the requirements\nprescribed under the PDPA; and\n\n \n\n(i)\n*Openness obligation*– an organization must implement the necessary policies and practices in order to meet the obligations\nunder the PDPA and shall make information about its policies and practices available on request.\n\n \n\nOrganisations\nhave mandatory obligations to assess data breaches they suffer, and to notify the Personal Data Protection Commission of Singapore (“PDPC”)\nand the relevant individuals affected by the data breach where the data breach is of a certain severity.\n\n \n\nThe\nPDPA establishes various offences relating to the improper use of personal data, certain methods of collecting personal data and certain\nnon-compliance with the requirements under the PDPA. These offences may be applicable to organisations, their officers, agents and/or\ntheir employees. Offenders may be liable on conviction to fines and/or imprisonment. The PDPA grants the PDPC significant regulatory\npowers to ensure compliance with the PDPA, including powers to investigate, give directions and impose financial penalties. In addition,\nthe PDPA created a right of private action, pursuant to which the Singapore courts may grant damages and/or relief by way of injunction\nor declaration, to persons who suffer loss or damage directly as a result of contraventions of certain requirements under the PDPA.\n\n \n\n*Do\nNot Call Obligations*\n\n \n\nApart\nfrom the data protection obligations imposed under the PDPA, the PDPA also generally prohibits organisations and individuals from sending\ndirect marketing messages (in the form of voice calls, text or fax messages) to Singapore telephone numbers, including mobile, fixed-line,\nresidential and business numbers, registered with the Do Not Call Registry (the “DNC Registry”), as maintained by the PDPC\n(the “DNC Obligations”). The DNC Obligations only apply to the sending of “specified messages” as defined in\nthe PDPA, which are marketing messages that offer, promote or advertise goods or services.\n\n \n\nPursuant\nto the DNC Obligations, before an organization sends any specified messages to a Singapore telephone number, it must check whether that\nSingapore telephone number is listed in the relevant register of the DNC Registry.\n\n \n\n**C.\nOrganizational structure.**\n\n \n\nSee\n“—A. History and Development of the Company.”\n\n \n\n**D.\nProperty, plants and equipment.**\n\n \n\nSee\n“—B. Business Overview—Facilities.”"}