{"url_path":"/sec/petv/10-k/2026/item-1","section_key":"item-1","section_title":"Item 1 BUSINESS**","topic":"sec","document":{"doc_type":"10-K","doc_date":"2026-06-29","source_url":"https://www.sec.gov/Archives/edgar/data/1512922/0001493152-26-031136-index.html","accession_number":"0001493152-26-031136","cik":"0001512922","ticker":"PETV","issuer_name":"PetVivo Holdings, Inc.","edgar_url":"https://www.sec.gov/Archives/edgar/data/1512922/0001493152-26-031136-index.html","primary_entity_key":"0001512922","primary_entity_name":"PetVivo Holdings, Inc."},"word_count":7586,"has_tables":true,"body_markdown":"**ITEM\n1. BUSINESS**\n\n \n\n**Overview**\n\n \n\nPetVivo\nHoldings, Inc. (the “Company,” “PetVivo,” “we” or “us) is an emerging biomedical device\ncompany focused on the manufacturing, commercialization, and licensing of innovative medical devices and therapeutics for animals.\nThe Company has a pipeline of seventeen products for the treatment of animals and humans. A portfolio of ten issued patents\n(consisting of six U.S. patents and four foreign patents), two U.S. patent applications, and six proprietary trade secrets protects\nthe Company’s biomaterials, products, production processes and methods of use. The Company began commercialization of its lead\nproduct Spryng® with OsteoCushion® Technology, a veterinarian-administered, intraarticular injection\nfor the management of lameness and other joint afflictions such as osteoarthritis in dogs and horses, in the second quarter of its\nfiscal year ended March 31, 2022.\n\n \n\nIn\nAugust 2021, we received net proceeds of approximately $9.7 million in a registered public offering (“Public Offering”) of\n2.5 million units at a public offering price of $4.50 per unit. Each unit consisted of one share of our common stock and one warrant\nto purchase one share of our common stock at an exercise price of $5.625 per share. The shares of common stock and warrants were transferable\nseparately immediately upon issuance. In connection with the Public Offering, the Company’s common stock and warrants were registered\nunder Section 12(b) of the Exchange Act and began trading on The Nasdaq Capital Market, LLC under the symbols “PETV” and\n“PETVW,” respectively. Presently, the Company is trading on the OTC Markets Group, under the OTCQX Best Market tier under the same symbols\n“PETV” and “PETVW,” respectively.\n\n \n\nThe\nCompany was incorporated in March 2009 under Nevada law. The Company operates as one segment from its corporate headquarters in Edina,\nMinnesota. For further information, see Note 1, *Description of the Business*, in the note to the consolidated financial statements\nin Part II, Item 8.\n\n \n\n**Business\nDescription**\n\n \n\nThe\nCompany is primarily engaged in the business of commercializing and licensing products in the veterinary market to treat and/or manage\nafflictions of companion animals such as cats, dogs and horses. Most of our technology was developed for human biomedical applications,\nand we intend to leverage the investments already expended in their development to commercialize treatments for horses and companion\nanimals in a capital and time-efficient way.\n\n \n\n3\n\n \n\n \n\nMany\nof the Company’s products are derived from proprietary biomaterials that simulate a body’s cellular tissue by virtue of their\nreliance upon natural protein and carbohydrate compositions which incorporate such “tissue building blocks” as collagen,\nelastin, and proteoglycans such as heparin. Since these are naturally-occurring in the body, we believe they have an enhanced biocompatibility\nwith living tissues compared to synthetic biomaterials such as those based upon alpha-hydroxy polymers (e.g PLA, PLGA, and the like),\npolyacrylamides, and other “natural” biomaterials that may lack the multiple proteins incorporated into our biomaterials.\nThese proprietary protein-based biomaterials that are similar to the body’s tissue thus allowing integration and tissue repair\nin long-term implantation in certain applications.\n\n \n\nOur\ninitial product, Spryng® is a veterinary medical device designed and engineered to provide a bio-integrative scaffold\nin the affected joint, promoting restoration of proper joint mechanics. Spryng® is an intra-articular injectable product\nof biocompatible and insoluble particles that are slippery, wet-permeable, durable, and resilient to enhance the force cushioning function\nof the synovial fluid and cartilage. The particles mimic natural cartilage in composition, structure, and hydration. Multiple joints\ncan be treated simultaneously. Our particles are comprised of naturally derived collagen, elastin, and a glycosaminoglycan (i.e. heparin);\nsuch particles mimic the composition and mechanical properties of extracellular matrix and natural cartilage. Spryng®\nassists in promoting a constructive restoration of diseased synovial tissue to improve the biomechanics and mechanical homeostasis of\nthe joint. Furthermore, these particles are designed and engineered to provide a bio-integrative scaffold in the affected joint, promoting\nrestoration of proper joint mechanics.\n\n \n\nOsteoarthritis,\na common inflammatory joint disease in both dogs and horses, is a chronic, progressive, degenerative joint disease that is caused by\na loss of synovial fluid and/or the deterioration of joint cartilage. Osteoarthritis affects approximately 14 million dogs and 1 million\nhorses in the $11 billion companion animal veterinary care and product sales market.\n\n \n\nDespite\nthe market size, veterinary clinics and hospitals have very few treatments and/or drugs for use in treating osteoarthritis in dogs, horses,\nand other pets. As there is no cure for osteoarthritis, current solutions treat symptoms, but do not manage the cause. The current treatment\nfor osteoarthritis in dogs generally consists of the use of nonsteroidal anti-inflammatory drugs (or “NSAIDs”) which are\napproved to alleviate pain and inflammation but present the potential for side effects relating to gastrointestinal, kidney, and liver\ndamage and do not halt or slow joint degeneration. The Company offers an alternative to traditional treatments that only address the\nsymptoms of the affliction. our Spryng® product addresses the affliction, loss of synovial fluid and/or the deterioration\nof joint cartilage, rather than treating just the symptoms and, to the best of our knowledge, has elicited minimal adverse side effects\nin dogs and horses. Spryng®-treated dogs and horses have shown an increase in activity even after they no longer are receiving pain\nmedication or other treatments. Other treatments for osteoarthritis include steroid and/or hyaluronic acid injections, which are used\nfor treating pain, inflammation and/or joint lubrication, but can be slow acting and/or short lasting.\n\n \n\nWe\nbelieve Spryng® is an optimal solution to safely improve joint function in animals for several reasons:\n\n \n\n \n●\nSpryng®\naddresses the underlying problems which relate to deterioration of cartilage causing pain and inflammation. Spryng®\nmimics the composition and mechanical properties of extracellular matrix and assists in promoting a constructive restoration of diseased\nsynovial tissue to improve the biomechanics and mechanical homeostasis of the joint.\n\n \n●\nSpryng®\nis easily administered with the standard intra-articular injection technique. Multiple joints can be treated simultaneously.\n\n \n●\nCase\nstudies indicate many dogs and horses have long-lasting multi-month improvement in lameness after having been treated with Spryng®\n\n \n●\nAfter\nreceiving a Spryng® injection, many canines are able to discontinue the use of NSAID’s, eliminating the risk\nof negative side effects.\n\n \n●\nSpryng®\nis an effective and economical solution for treating osteoarthritis. A single injection of Spryng® is approximately\n$600 to $900 per joint and typically lasts for at least 12 months.\n\n \n\nHistorically,\ndrug sales represent up to 30% of revenues at a typical veterinary practice (Veterinary Practice News). Revenues and margins at veterinary\npractices are being eroded because online, big-box, and traditional pharmacies have recently started filling veterinary prescriptions.\nVeterinary practices are looking for ways to replace lost prescription revenues with safe and effective products. Spryng®\nis a veterinarian-administered medical device that should expand practice revenues and margins. We believe that the increased revenues\nand margins provided by Spryng® will accelerate its adoption rate and propel it forward as the standard of care for canine\nand equine lameness related to or due to synovial joint issues.\n\n \n\n4\n\n \n\n \n\nWe\ncommenced sales of Spryng® in the second quarter of fiscal 2022 and plan to increase our commercialization efforts of\nSpryng® in the United States through the use of sales reps, clinical studies and market awareness to educate and inform\nkey opinion leaders on the benefits of Spryng®.\n\n \n\nWe\nentered into a Distribution Services Agreement (“Distribution Agreement”) with MWI on June 17, 2022. Pursuant to the Agreement,\nwe appointed MWI to distribute, advertise, promote, market, supply, and sell the Company’s lead product, Spryng®\non an exclusive basis for two (2) years within the United States (the “Territory”), transitioning to a non-exclusive basis\nthereafter; provided however that the Company shall extend the exclusivity for an additional one (1) year if MWI achieves certain performance\ntargets agreed upon by the parties. The Company can continue to sell Spryng® within the Territory to established accounts,\nwhich include: (a) customers who have purchased Spryng® from the Company prior to the date of the Agreement, (b) customers\nwho require that they deal directly with the Company, (c) governmental agencies, and (d) customers that order via the internet who are\nnot directly solicited by MWI to purchase Spryng®. All customers must be licensed veterinary practices.\n\n \n\nIn\nDecember 2023, the Company and MWI agreed to change the Distribution Agreement from an exclusive distribution agreement to a non-exclusive\ndistribution agreement, effective as of January 1, 2024. This is consistent with the Company’s strategy to create multiple sales\nchannels for its products. In March 2025, the Company mutually terminated its non-exclusive distribution agreement with MWI. In December\n2023, the Company entered into a non-exclusive distribution agreement with Covetrus North America, LLC (“Covetrus Distribution\nAgreement”), to market, distribute and sell the Company’s products in the United States, including the District of Columbia.\nThe Covetrus Distribution Agreement had an initial term of one year, which was not automatically renewed. The Company mutually terminated\nits non-exclusive distribution agreement with Covetrus North America, LLC in February 2025.\n\n \n\nIn\nDecember 2024, we entered into new wholesale distribution partnerships with Vedco Inc. (“Vedco”) and Clipper Distributing,\nLLC (“Clipper”), both leaders in logistical solutions and supply of products to veterinarians through the channel-of-distribution\nfor veterinarians. Both MWI and Covetrus have the capability to purchase directly from Vedco and/or Clipper.\n\n \n\nSpryng®\nis classified as a veterinary medical device under the United States Food and Drug Administration (“FDA”) rules and pre-market\napproval is not required by the FDA. Spryng® completed a safety and efficacy study in rabbits in 2007. Since that time,\nmore than 2,000 horses and dogs have been treated with Spryng®. We entered into a clinical trial services agreement with\nColorado State University on November 5, 2020. This university clinical study was completed in March 2024. Additionally, the Company\nsuccessfully completed an equine tolerance study in March 2022 and began a two canine clinical study with Ethos Veterinary Health, the\nfirst beginning in May of 2022 which was completed in October 2023, and the second began in June of 2023 with an expected completion\nin October 2024. We anticipate these and other studies that we plan to initiate will be primarily used to expand our distribution outlets\nsince the large international and national distributors generally require a third-party university study and other third-party studies\nprior to including a product in their catalog of products.\n\n \n\nWe\nmanufacture our products in an ISO 7 certified clean room manufacturing facility in Minneapolis using our patented and scalable self-assembly\nproduction process, which minimizes the infrastructure requirements and manufacturing risks to deliver a consistent, high-quality product\nwhile being responsive to volume requirements. A second ISO cleanroom facility is expected to be operational later this year. We believe\nthat having two manufacturing facilities will help us minimize supply risks, allow for continued scaling or our production capacity,\nand expand our research and development facilities.\n\n \n\nWe\nalso have a pipeline that includes 17 therapeutic devices for both veterinary and human clinical applications. Some such devices may\nbe regulated by the FDA or other equivalent regulatory agencies, including but not limited to the Center for Veterinary Medicine (“CVM”).\nWe anticipate growing our product pipeline through the acquisition or in-licensing of additional proprietary products from human medical\ndevice companies specifically for use in pets. In addition to commercializing our own products in strategic market sectors and in view\nof the Company’s vast proprietary product pipeline, the Company may establish strategic out-licensing partnerships to provide secondary\nrevenues.\n\n \n\n5\n\n \n\n \n\nIn\nFebruary 2025, the Company signed an exclusive licensing agreement with VetStem, Inc. to market and sell their PrecisePRP (Platelet-Rich\nPlasma) product for both canine and equine. Revenues were incurred in fiscal year 2026.\n\n \n\n**Product\nPipeline: Other Potential Biocoacervate and Protein Based Products**\n\n** **\n\n \n\n \n\nBelow\nis a list of applications of our technology that we plan to commercialize or out-license to strategic partners:\n\n \n\n**Dermal\nFiller**\n\n \n\nOur\nbiomaterials are constructed from purified water, protein, and carbohydrate, tailored to simulate different body tissues that biologically\nintegrate (bio-integration). Our biomaterials can be manufactured and used as a dermal filler for wrinkle treatment by injection. These\nformed, gel particles fill, integrate and rejuvenate dermal skin tissue to remove the wrinkle. This product was taken through an FDA\nclinical trial under the name CosmetaLife®, see the results here: www.clinicaltrials.gov (NCT00414544).\n\n \n\n**Cardiovascular\nDevices**\n\n \n\nOur\nblood-compatible biomaterial, which allows blood contact and bio-integrative processes to occur without clotting, platelet attachment,\nor thrombogenesis, is used to repair cardiovascular tissue. VasoGraft®, a blood vessel graft made from VasoCover™\nmaterial, is designed to mimic natural blood vessel tissue in almost every respect, including the components used.\n\n \n\n**Drug\nDelivery**\n\n \n\nUnique\nfabrication techniques allow us to homogeneously distribute the drug in milligram to nanogram amounts, resulting in optimum performance\nand manufacturing capabilities for a variety of delivery methods, such as coatings, injectables, implantables, or transmucosal delivery.\nThe first planned transmucosal product has been optimized and tested with peptide drugs with better efficacy than oral dosing via swallowing.\n\n \n\n6\n\n \n\n \n\n**Orthopedic\nDevices**\n\n \n\nAnother\nof our materials can be used in a variety of shapes for orthopedic and dental applications. The first products, OrthoGelic™ and\nOrthoMetic™, will be aimed at difficult-to-heal, non-union broken bones, by using particles to fill the empty space. The orthopedic\nbiomaterial, made to mimic the structural components of bone, can allow integration and healing to fill in the break and exclude non-bone\ntissue infiltration.\n\n \n\n**Intellectual\nProperty**\n\n \n\nOur\nintellectual property portfolio is comprised of patents, patent applications, trademarks, and trade secrets. We have six patents issued\nand 2 patent applications pending in the United States. In addition to the United States patent portfolio, we also have four patents\ngranted in key markets around the world including Canada and countries within the European Union.\n\n \n\nWe\nbelieve we have developed a broad and deep patent portfolio around our biomaterials and manufacturing processes in addition to the application\nof these biomaterials for use as medical devices, medical device coatings, and pharmaceutical delivery devices. The Company secures other\ntechnological know-how by trade secret law and also possesses several trademarks that are either registered or protected pursuant to\ntrademark common law.\n\n \n\nUnited\nStates Patents:\n\n \n\n \n●\n**11,890,371**\n– Biocompatible Protein-Based Particles and Methods Thereof\n\n \n●\n**11,975,121**\n– Protein Biomaterials and Bioacervates and Methods of Making and Using Thereof\n\n \n●\n**10,744,236**\n- Protein Biomaterial and Biocoacervate Vessel Graft Systems and Methods of Making and Using Thereof\n\n \n●\n**10,016,534**– Protein Biomaterial and Biocoacervate Vessel Graft Systems and Methods of Making and Using Thereof\n\n \n●\n**8,623,393**– Biomatrix Structural Containment and Fixation Systems and Methods of Use Thereof\n\n \n●\n**8,529,939**– Mucoadhesive Drug Delivery Devices and Methods of Making and Using Thereof\n\n \n\nTo\nmaximize the strength and value of our patent portfolio, many of the claims use the transitional term “comprising”, which\nis synonymous with “including,” This use of transitional language is inclusive or open-ended and does not exclude additional,\nunrecited elements or method steps. Our patents also include method claims covering many of the applications and uses of the biomaterials\nas medical devices and drug delivery systems. We believe our intellectual property portfolio strongly protects our proprietary technology,\nincluding the composition of raw elements used to produce our formulations, the fabricated biomaterials, and their application in end\nproducts, thereby making our material and devices much more attractive to industry partners.\n\n \n\nFurthermore,\nwe rely on proprietary trade secrets and confidential know-how to protect various aspects of its product formulations and manufacturing\nprocesses. The Company has six documented trade secrets that include, but are not limited to, unique ingredient compositions, specialized\nblending and production techniques, quality control procedures, and process efficiencies that have been developed and refined through\nyears of internal research and development. These proprietary methods are central to the performance, stability, and scalability of the\nproducts currently commercialized by the Company. To safeguard this intellectual property, the Company maintains strict internal controls,\nincluding non-disclosure agreements, restricted access protocols, and employee confidentiality and invention assignment agreements. Although\ntrade secrets do not offer the same legal protections as patents, the Company believes that its robust internal policies and the technical\ncomplexity of its formulations and processes provide significant competitive advantage and barriers to entry.\n\n \n\nWe\nwill seek to protect our products and technologies through a combination of patents, regulatory exclusivity, and proprietary know-how.\nOur goal is to obtain, maintain and enforce patent protection for our products, formulations, processes, methods, and other proprietary\ntechnologies, preserve our trade secrets, and operate without infringing on the proprietary rights of other parties, both in the United\nStates and in other countries. Our policy is to actively seek to obtain, where appropriate, the broadest intellectual property protection\npossible for our current compounds and any future compounds developed. We also strenuously protect our proprietary information and proprietary\ntechnology through a combination of contractual arrangements, trade secrets, and patents, both in the United States and abroad. However,\neven patent protection may not always afford us with complete protection against competitors who seek to circumvent our patents.\n\n \n\n7\n\n \n\n \n\nWe\ndepend upon the skills, knowledge, and experience of our scientific and technical personnel, including those of our company, as well\nas that of our advisors, consultants, and other contractors, none of which is patentable. To help protect our proprietary know-how, which\nmay not be patentable, and inventions for which patents may be difficult to obtain or enforce, we rely on trade secret protection and\nconfidentiality agreements to protect our interests. To this end, we generally require all of our employees, consultants, advisors, and\nother contractors to enter into confidentiality agreements that prohibit disclosure of confidential information and, where applicable,\nrequire disclosure and assignment of ownership to us the ideas, developments, discoveries, and inventions important to our business.\n\n \n\nFinally,\nwe rely on a combination of registered and unregistered intellectual property to protect our brand and products. As of the date of this\nfiling, we own two United States federally registered trademarks: Spryng® and OsteoCushion®, both of which are actively used\nin commerce in connection with our core products and services. In addition, we assert common law trademark rights in PetVivo™,\nwhich has been used continuously in the marketplace in association with our business since approximately 2014. We also own various copyrights\nthat protect our original works of authorship, including proprietary product documentation, website content, marketing materials, clinical\npublications and other creative and technical content developed internally or acquired through business operations. These trademarks\nand copyrights are important assets that support our brand identity, help safeguard the unique elements of our products, differentiate\nour offerings, enhance our user experience and contribute to our competitive position. We actively monitor and enforce our trademark\nand copyright rights to protect against infringement or misuse.\n\n \n\n**Companion\nAnimal Market**\n\n \n\nOver\nthe last several decades, we believe the animal health market and industry has a strong component in the overall U.S. economy and is\nmore resistant to economic cycles. The veterinary sector is an attractive area to participate in the growth of the broader healthcare\nindustry without reimbursement risk. The American Pet Products Association (APPA) 2021-2022 National Pet Owners Survey indicates that\n$123.6 billion was spent on pets in the U. S. in 2021. Vet Care and product sales constitute about $34.3 billion of the market. The growth\nin the U.S. companion animal market has been continuing to increase due to the increase in the number of pet-owning households.\n\n \n\nThe\nAPPA 2021-2022 National Pet Owners Survey indicates U.S. pet ownership reached record levels in 2022. Specifically, 70% of all U.S. households\nowned a pet in 2022. That’s 90.5 million pet-owning households, up from 84.6 million in 2018. In 2022, dogs and cats were the most\npopular pet species, owned by 69% and 45% of U.S. households, respectively. APPA also reported that there were 69.0 million dogs and\n45.3 million cats in the U.S. APPA reported that 3.5% of U.S. households owned horses in 2022. According to the American Horse Council,\nthe total number of horses owned by U.S. households was 7.2 million.\n\n \n\n**Osteoarthritis\nMarket**\n\n \n\nOsteoarthritis,\nthe most common inflammatory joint disease in both dogs and horses, is a progressive condition that is caused by a deterioration of joint\ncartilage. Over time, the joint cartilage deterioration creates joint stiffness from mechanical stress resulting in inflammation, pain,\nand loss of range of motion, which may be referred to as lameness. Osteoarthritis joint stiffness and lameness worsen with time from\ngradual cartilage degeneration and an ongoing loss of protective cushion and lubricity (i.e., loss of slippery padding). As there is\nno cure for osteoarthritis, the various treatment methods are focused on managing the related symptoms of pain and inflammation. Veterinarians\nrecommend several treatments depending on the severity of the disease, including a combination of rest, weight loss, physical rehabilitation,\nand a regimen of pain and anti-inflammatory drugs (NSAIDs). Non-steroidal anti-inflammatory drugs (NSAIDs) are used to alleviate the\npain and inflammation caused by OA, but long-term NSAIDs cause gastric problems. Moreover, NSAIDs do not treat the cartilage degeneration\nissue to halt or slow progression of the OA condition.\n\n \n\nThe\nMorris Animal Foundation estimates that OA affects approximately 14 million adult dogs in the U.S. and owners consistently report it\nas a top concern.\n\n \n\n8\n\n \n\n \n\n**Horse\nOsteoarthritis (Lameness)**\n\n \n\nEquine\nosteoarthritis is the most common cause of lameness in horses. Equine OA is expensive to manage, with estimated annual costs as high\nas $10,000-15,000 per horse to diagnose, treat, and medicate, researchers found in one study as referenced in the Horse – Equine\nMonthly.\n\n \n\nAs\nnoted previously, the American Horse Council reported the total number of horses owned by U.S. households was 7.2 million. According\nto an annual National Equine Health Survey conducted in collaboration with the British Equine Veterinary Association in 2016, 26% of\nhorses suffered from lameness. As referenced in the Horse–Equine Monthly, studies show 60% of all lameness issues are related to\nOA. Based on the above assumptions we calculate that there are approximately 1.1 million horses suffering from OA.\n\n \n\n**Distribution**\n\n \n\nMost\nU.S. veterinarians buy a majority of their equipment and supplies from a preferred distributor. More than 75% of veterinarians name Covetrus\nNorth America/Butler Schein Animal Health, Inc., Patterson Veterinary, MWI, Midwest Veterinary Supply, Inc., or Victor Medical Company\nas their preferred distributor. Combined, these top-tier distributors sell more than 85%, by revenue, of the products sold to companion\nanimal veterinarians in the U.S. Covetrus, Patterson, and MWI are recognized by manufacturers, distributors, and veterinarians as the\npre-eminent national companion animal veterinary supply distributors in the US. There are no other distributors that provide equivalent\nlevels of service to manufacturers and regularly visit veterinarians in as wide a geographic area as Covetrus, Patterson or MWI. Midwest\nand Victor are large, regional distributors. The above data in this paragraph was sourced from File No. 101 0023 at the U.S. Federal\nTrade Commission.\n\n \n\nWe\ncommenced sales of Spryng® in the second quarter of fiscal 2022 and plan to increase our commercialization efforts of\nSpryng® in the United States through our distribution relationship with MWI Veterinary Supply Co. (“Distributor”\nor “MWI”) and the use of sales reps, clinical studies, and market awareness to educate and inform key opinion leaders on\nthe benefits of Spryng®.\n\n \n\nWe\nentered into a Distribution Services Agreement (“Distribution Agreement”) with MWI on June 17, 2022. Pursuant to the Agreement,\nwe appointed MWI to distribute, advertise, promote, market, supply, and sell the Company’s lead product, Spryng®\non an exclusive basis for two (2) years within the United States (the “Territory”), transitioning to a non-exclusive basis\nthereafter; provided however that the Company shall extend the exclusivity for an additional one (1) year if MWI achieves certain performance\ntargets agreed upon by the parties. The Company can continue to sell Spryng® within the Territory to established accounts,\nwhich include: (a) customers who have purchased Spryng® from the Company prior to the date of the Agreement, (b) customers\nwho require that they deal directly with the Company, (c) governmental agencies, and (d) customers that order via the internet who are\nnot directly solicited by MWI to purchase Spryng®. All customers must be licensed veterinary practices. In March 2025,\nwe mutually terminated our non-exclusive distribution agreement with MWI.\n\n \n\nWe\nentered into a Distribution Services Agreement (the “Agreement”) with Covetrus on December 18, 2023. Pursuant to the Agreement,\nwe appointed Covetrus to distribute, advertise, promote, market, supply, and sell the Company’s lead product, Spryng®\non an exclusive basis for two (2) years within the United States (the “Territory”), transitioning to a non-exclusive basis\nthereafter; provided however that the Company shall extend the exclusivity for an additional one (1) year if MWI achieves certain performance\ntargets agreed upon by the parties. The Company can continue to sell Spryng® within the Territory to established accounts,\nwhich include: (a) customers who have purchased Spryng® from the Company prior to the date of the Agreement, (b) customers\nwho require that they deal directly with the Company, (c) governmental agencies, and (d) customers that order via the internet who are\nnot directly solicited by MWI to purchase Spryng®. All customers must be licensed veterinary practices. In February 2025,\nwe mutually terminated our non-exclusive distribution agreement with Covetrus.\n\n \n\nIn\nDecember 2024, the Company entered into new wholesale distribution partnerships with Vedco, Inc. (“Vedco”) and Clipper Distributing,\nLLC (“Clipper”). A distribution service agreement was not signed with either distribution partner. Both MWI and Covetrus\nhave the capability to purchase directly from both distributors.\n\n \n\n9\n\n \n\n \n\n**Orthopedic\nJoint Treatments**\n\n \n\nA\ntreatment for joint pain, which is made of injected, protein-based, biocompatible particles. In vivo studies indicate that the biocompatible\nparticle device can easily be combined with synovial fluid in a rabbit knee to form a joint cushion, buffering the adjacent bones/cartilage\nwhere no damage was caused to the cartilage from replacing the synovial fluid. The particles show an effectiveness to augment and reinforce\nthe tissue, cartilage, ligaments and/or bone and/or enhance the functionality of the joint (e.g. reinforce deteriorated components present\nin the joint to provide cushion or shock-absorbing features to the joint and to provide joint lubricity).\n\n \n\nAppTec\nLaboratories accomplished a gel-particle rabbit study. In short, New Zealand white rabbits (6) were injected in both stifle joints (knees)\nto fill but not extend the synovial space (~0.5 cc GDP/site). Rabbits were tested every other day for abnormal clinical signs including\nrange of motion and joint observations until sacrifice. Behavioral testing revealed no abnormal scores for range of motion, withdrawal\nresponse, or joint observations (all animals were 100% normal). At one week and at four weeks the animals were sacrificed. AppTec pathologists\nevaluated knee joint histology. The reported cartilage surfaces of the femoral and tibia condyles and the menisci were grossly and histologically\n100% normal for all animals and test sites. The test particles were found in all of the injection sites.\n\n \n\nThe\ntest particle did not cause changes in the articular cartilage of the femur or tibia when injected into the stifle joint of rabbits.\nThe test article and control rabbit knees were not different for either 1 or 4-week time points for all histological measurements. In\nconclusion, the particles do not cause inflammation or damage to knee joint and will stick to exposed tissues and biologically integrate\nwith those tissues. The particles were not found to stick to articular cartilage in any sample.\n\n \n\n**Regenerative\nCharacteristics**\n\n \n\nThe\nparticle devices for joint injections have been extensively studied for a broad range of applications including the treatment of wrinkles\nas dermal filler. Here is an overview of the pre-clinical and clinical studies completed for CosmetaLife, which is the name used for\nthe particle device when it was used as a dermal filler.\n\n \n\nCosmetaLife\nis an easy-to-inject, water-protein-based dermal filler that not only fills nasolabial wrinkle depressions but also helps rejuvenate\nthe dermal tissues, counteracting damage that causes wrinkles. The dermal cells are attracted to the CosmetaLife gel-particles, attach\nto them, and then slowly replace them with natural dermal material (extracellular matrix). The natural biological replacement process\nof CosmetaLife to collagen is estimated to take 6-12 months. CosmetaLife clinical trial on nasolabial folds supports this estimate.\n\n \n\nCosmetaLife\ninjections allow the body to create a more natural dermal structure in and around every particle. Enhancing the natural process of dermal\ntissue construction with CosmetaLife allows for long-term dermal contouring, corrections, and rejuvenation with little to no adverse\nside effects noted in clinical trials.\n\n \n\n**Particle\nDevice Clinical Studies**\n\n \n\nThe\nCompany has conducted several biocompatibility animal studies. In the implantation study, no abnormal clinical signs were noted for any\nof the rabbits. The results of the sensitization study in guinea pigs showed a sensitization response equivalent to the negative controls.\n\n \n\nA\nFood and Drug Administration (FDA) IDE approved pivotal human clinical trial began with CosmetaLife late in 2006. The clinical trial\nwas a randomized, double-blind, parallel assignment, multi-center comparison of the safety and efficacy of CosmetaLife versus Restylane®\n(Control) for the correction of nasolabial folds. One hundred seventy-one patients were skin tested and 145 were treated at six trial\nsites. The number of study exits after treatment totaled four subjects. This clinical trial was reported and published at www.clinicaltrials.gov\n(NCT00414544).\n\n \n\nThe\nfeedback from physician investigators has been positive with respect to CosmetaLife injection qualities, cosmetic appearance, and its\nfeel to the touch. During the first three to four months of the study, CosmetaLife showed no decrease in efficacy, as compared to Restylane\nwhich showed an 11 percent decrease in efficacy. The FDA/IDE approved human clinical trial for the CosmetaLife product through twelve\nmonths was found to be the same as compared to control hyaluronic acid product, Restylane (for each interval the consensus of the blinded\nsubjects tested preferred CosmetaLife or showed no preference at 3, 6, 9 and 12 months).\n\n \n\n10\n\n \n\n \n\nWe\nuse existing, scalable processes to reduce the infrastructure requirements and manufacturing risks to deliver a consistent, high-quality\nproduct while being responsive to volume requirements. We are able to scale the manufacturing process having made batches in up to 2.0-kilogram\nquantities to near GMP (Good Manufacturing Practices) standards.\n\n** **\n\n**Particles\nSafety Study**\n\n \n\nPatients\ninjected with CosmetaLife were found to have no or mild inflammatory, irritation, or immunogenic responses. These results suggest the\nparticles are biocompatible because it closely matches the skin structure, composition, and moisture content. The no-to-low immunogenic\nresponses are attributed to the tight cross-linking of the CosmetaLife matrix, which prevents immunogenic progenitor cells from producing\nantibodies to the matrix.\n\n \n\nIn\nthe clinical trial, the incidence of possible reaction to a skin test was 2.55 percent, with only one subject showing a reaction to a\nsecond test or 0.6%, (1 out of 171). We also have a study report by AppTec, Inc., our Contract Research Organization, that CosmetaLife\ndid not produce an antibody response during the clinical trial further supporting our belief that it is safe to use.\n\n \n\nCosmetaLife\nis composed of materials that approximately meet the Generally Regarded As Safe (GRAS) requirements of the FDA. CosmetaLife contains\nmaterials from certified bovine and porcine tissue sources that do not harbor prion disease or BSE. Additionally, steps in the manufacturing\nprocess have been validated for deactivating all viruses.\n\n \n\nExtrusion\nforce testing and the Clinical Trial usage both demonstrate the consistent and easy injection of CosmetaLife. Twenty-five month stability\ntesting shows that CosmetaLife is stable at room temperature conditions. Moreover, CosmetaLife has been shown to be stable at 40 °C\n(104 °F) conditions for at least 3 months.\n\n** **\n\n**Competition**\n\n \n\nThe\ndevelopment and commercialization of new animal health medicines is highly competitive, and we expect considerable competition from major\npharmaceutical, biotechnology, and specialty animal health medicines companies. As a result, there are, and likely will continue to be,\nextensive research and substantial financial resources invested in the discovery and development of new animal health medicines. Our\npotential competitors include large animal health companies, such as Zoetis, Inc.; Merck Animal Health, the animal health division of\nMerck & Co., Inc.; Merial, the animal health division of Sanofi S.A.; Elanco, the animal health division of Eli Lilly and Company;\nBayer Animal Health, the animal health division of Bayer AG; NAH, the animal health division of Novartis AG; Boehringer Ingelheim Animal\nHealth, the animal health division of Boehringer Ingelheim GmbH; Virbac Group; Ceva Animal Health; Vetoquinol and Dechra Pharmaceuticals\nPLC. We are also aware of several smaller early stage animal health companies, such as Kindred Bio, Aratana Therapeutics Inc. (recently\nacquired by Elanco), NextVet and VetDC that are developing products for use in the pet therapeutics market.\n\n \n\n**Regulation\n– Human and Veterinary Use**\n\n \n\nA\nnumber of the medical devices that we manufacture for veterinary applications, and plan to manufacture for human applications, are subject\nto regulation by numerous regulatory bodies, including the FDA and comparable international regulatory agencies. These agencies require\nmanufacturers of medical devices to comply with applicable laws and regulations governing the development, testing, manufacturing, labeling,\nmarketing, and distribution of medical devices. Medical devices are generally subject to varying levels of regulatory control, the most\ncomprehensive of which requires that a clinical evaluation program be conducted before a device receives approval for commercial distribution.\n\n \n\nIn\nthe EU, medical devices are required to comply with the Medical Devices Directive and obtain CE Mark certification in order to market\nmedical devices. The CE Mark certification, granted following approval from an independent Notified Body, is an international symbol\nof adherence to quality assurance standards and compliance with applicable European Medical Devices Directives. Distributors of medical\ndevices may also be required to comply with other foreign regulations such as Ministry of Health Labor and Welfare approval in Japan.\nThe time required to obtain these foreign approvals to market our products may be longer or shorter than that required in the U.S., and\nrequirements for those approvals may differ from those required by the FDA. In Europe, our devices are classified as Class IIa or IIb,\nand will need to conform to the Medical Devices Regulation.\n\n \n\n11\n\n \n\n \n\nIn\nthe U.S., specific permission from the FDA to distribute a new device is usually required (that is, other than in the case of very low-risk\ndevices), and we expect that some form of marketing authorization will be necessary for our devices. Marketing authorization is generally\nsought and obtained in one of two ways. The first process requires that a pre-market notification (510(k) Submission) be made to the\nFDA to demonstrate that the device is as safe and effective as, or “substantially equivalent” to, a legally-marketed device\nthat is not subject to pre-market approval (“PMA”). A legally-marketed device is a device that (i) was legally marketed prior\nto May 28, 1976, (ii) has been reclassified from Class III to Class II or I, or (iii) has been found to be substantially equivalent to\nanother legally-marketed device following a 510(k) Submission. The legally-marketed device to which equivalence is drawn is known as\nthe “predicate” device. Applicants must submit descriptive data and, when necessary, performance data to establish that the\ndevice is substantially equivalent to a predicate device. In some instances, data from human clinical studies must also be submitted\nin support of a 510(k) Submission. If so, these data must be collected in a manner that conforms with specific requirements in accordance\nwith federal regulations including the Investigational Device Exemption (IDE) and human subjects protections or “Good Clinical\nPractice” regulations. After the 510(k) application is submitted, the applicant cannot market the device unless FDA issues “510(k)\nclearance” deeming the device substantially equivalent. After an applicant has obtained clearance, the changes to existing devices\ncovered by a 510(k) Submission that do not significantly affect safety or effectiveness can generally be made without additional 510(k)\nSubmissions, but evaluation of whether a new 510(k) is needed is a complex regulatory issue, and changes must be evaluated on an ongoing\nbasis to determine whether a proposed change triggers the need for a new 510(k), or even PMA. The 510(k) clearance pathway is not available\nfor all devices: whether it is a suitable path to market depends on several factors, including regulatory classifications, the intended\nuse of the device, and technical and risk-related issues for the device.\n\n \n\nThe\nsecond, more rigorous, process requires that an application for PMA be made to the FDA to demonstrate that the device is safe and effective\nfor its intended use as manufactured. This approval process applies to most Class III devices. A PMA submission includes data regarding\ndesign, materials, bench and animal testing, and human clinical data for the medical device. Again, clinical trials are subject to extensive\nFDA regulation. Following completion of clinical trials and submission of a PMA, the FDA will authorize commercial distribution if it\ndetermines there is reasonable assurance that the medical device is safe and effective for its intended purpose. This determination is\nbased on the benefit outweighing the risk for the population intended to be treated with the device. This process is much more detailed,\ntime-consuming, and expensive than the 510(k) process. Also, FDA may impose a variety of conditions on the approval of a PMA.\n\n \n\nBoth\nbefore and after a device for the U.S. market is commercially released, we would have ongoing responsibilities under FDA regulations.\nThe FDA reviews design and manufacturing practices, labeling and record keeping, and manufacturers’ required reports of adverse\nexperiences and other information to identify potential problems with marketed medical devices. We would also be subject to periodic\ninspection by the FDA for compliance with the FDA’s quality system regulations, which govern the methods used in, and the facilities\nand controls used for, the design, manufacture, packaging, and servicing of all finished medical devices intended for human use. In addition,\nthe FDA and other U.S. regulatory bodies (including the Federal Trade Commission, the Office of the Inspector General of the Department\nof Health and Human Services, the Department of Justice (DOJ), and various state Attorneys General) monitor the manner in which we promote\nand advertise our products. Although physicians are permitted to use their medical judgment to employ medical devices for indications\nother than those cleared or approved by the FDA, we are prohibited from promoting products for such “off-label” uses and\ncan only market our products for cleared or approved uses. If the FDA were to conclude that we are not in compliance with applicable\nlaws or regulations, or that any of our medical devices are ineffective or pose an unreasonable health risk, the FDA could require us\nto notify health professionals and others that the devices present unreasonable risks of substantial harm to the public health, order\na recall, repair, replacement, or refund of such devices, detain or seize adulterated or misbranded medical devices, or ban such medical\ndevices. The FDA may also impose operating restrictions, enjoin and/or restrain certain conduct resulting in violations of applicable\nlaw pertaining to medical devices, including a hold on approving new devices until issues are resolved to its satisfaction, and assess\ncivil or criminal penalties against our officers, employees, or us. The FDA may also recommend prosecution to the DOJ. Conduct giving\nrise to civil or criminal penalties may also form the basis for private civil litigation by third-party payers or other persons allegedly\nharmed by our conduct.\n\n \n\n12\n\n \n\n \n\nThe\ndelivery of our devices in the U.S. market would be subject to regulation by the U.S. Department of Health and Human Services and comparable\nstate agencies responsible for reimbursement and regulation of healthcare items and services. U.S. laws and regulations are imposed primarily\nin connection with the Medicare and Medicaid programs, as well as the government’s interest in regulating the quality and cost\nof health care.\n\n \n\nFederal\nhealthcare laws apply when we or customers submit claims for items or services that are reimbursed under Medicare, Medicaid, or other\nfederally-funded healthcare programs. The principal federal laws include: (1) the False Claims Act which prohibits the submission of\nfalse or otherwise improper claims for payment to a federally-funded health care program; (2) the Anti-Kickback Statute which prohibits\noffers to pay or receive remuneration of any kind for the purpose of inducing or rewarding referrals of items or services reimbursable\nby a Federal health care program; (3) the Stark law which prohibits physicians from referring Medicare or Medicaid patients to a provider\nthat bills these programs for the provision of certain designated health services if the physician (or a member of the physician’s\nimmediate family) has a financial relationship with that provider; and (4) health care fraud statutes that prohibit false statements\nand improper claims to any third-party payer. There are often similar state false claims, anti-kickback, and anti-self-referral and insurance\nlaws that apply to state-funded Medicaid and other health care programs and private third-party payers. In addition, the U.S. Foreign\nCorrupt Practices Act can be used to prosecute companies in the U.S. for arrangements with physicians, or other parties outside the U.S.\nif the physician or party is a government official of another country and the arrangement violates the law of that country.\n\n \n\nThe\nlaws applicable to us are subject to change, and subject to evolving interpretations. If a governmental authority were to conclude that\nwe are not in compliance with applicable laws and regulations, we and our officers and employees could be subject to severe criminal\nand civil penalties including substantial fines and damages, and exclusion from participation as a supplier of product to beneficiaries\ncovered by Medicare or Medicaid.\n\n \n\nThe\nprocess of obtaining clearance to market products is costly and time-consuming in virtually all of the major markets in which we expect\nto sell products and may delay the marketing and sale of our products. Countries around the world have recently adopted more stringent\nregulatory requirements, which are expected to add to the delays and uncertainties associated with new product releases, as well as the\nclinical and regulatory costs of supporting those releases. No assurance can be given that any of our other medical devices will be approved\non a timely basis, if at all. In addition, regulations regarding the development, manufacture, and sale of medical devices are subject\nto future change. We cannot predict what impact, if any, those changes might have on our business. Failure to comply with regulatory\nrequirements could have a material adverse effect on our business, financial condition, and results of operations.\n\n \n\nPertaining\nto our Spryng® product (offered for veterinary use only), in the U.S., the FDA does not require submission of a 510(k), PMA, or any\npre-market approval for devices used in veterinary medicine. Device manufacturers who exclusively manufacture or distribute veterinary\ndevices are not required to register their establishments and list veterinary devices and are exempt from post-marketing reporting. The\nFDA does have regulatory oversight over veterinary devices and can take appropriate regulatory action if a veterinary device is misbranded\nor adulterated. It is the responsibility of the manufacturer and/or distributor of these articles to assure that these animal devices\nare safe, effective, and properly labeled.\n\n \n\nExported\ndevices are subject to the regulatory requirements of each country to which the device is exported. Some countries do not have medical\ndevice regulations, but in most foreign countries medical devices are regulated. Frequently, medical device companies may choose to seek\nand obtain regulatory approval of a device in a foreign country prior to application in the U.S. given the different regulatory requirements.\nHowever, this does not ensure approval of a device in the U.S.\n\n \n\n**Research\nand Development**\n\n \n\nThe\nCompany is currently pursuing advancements in the composition, methods of manufacture and use for its proprietary biomaterials. It is\nanticipated that within the next twelve months the Company will pursue additional third-party studies related to the use of Spryng®\nfor the treatment of osteoarthritis in canine and equine patients. The Company also anticipates that resources will be expended to advance\nand improve the manufacturing systems for Spryng® that will increase product volume and overall efficiency. Finally, the\nCompany anticipates that research and testing will be conducted in the next eighteen months involving the existing Spryng®\nformulation and other variations to identify and determine the next commercial product(s) that may be administered to the digital cushion\nof horses for the treatment of navicular disease.\n\n \n\n13\n\n \n\n \n\n**Employees\nand Human Capital**\n\n \n\nAs\nof June 29, 2026, we have 22 employees. We also engage outside consultants to assist with research and development, clinical development\nand regulatory matters, investor relations, operations, and other functions from time to time.\n\n \n\nThe\nCompany believes that its success depends on the ability to attract, develop, and retain key personnel. It also believes that the skills,\nexperience, and industry knowledge of its employees significantly benefit its operations and performance. The Company believes that it\noffers competitive compensation and other means of attracting and retaining key personnel. None of our employees are represented by a\nlabor union and we believe that our relationships with our employees are good.\n\n \n\n**Insurance**\n\n \n\nWe\ncurrently maintain a “life science” commercial insurance policy with coverage in the amount of $2 million for our products\nand operations. The policy has been designed for those engaged in the life science business. We may face claims in excess of the limits\nof such insurance. As well, claims made against us may fall outside of our coverage. The policy is a “claims made” policy.\nThus, our coverage must be maintained at the time a claim is made for us to be entitled to seek coverage from the issuer of the policy\nfor such claims.\n\n \n\nAvailable\nInformation\n\n \n\nWe\nmake available, free of charge and through our Internet website at www.petvivo.com, our Annual Reports on Form 10-K, Quarterly Reports\non Form 10-Q, Current Reports on Form 8-K, and any amendments to any such reports filed or furnished pursuant to Section 13(a) or 15(d)\nof the Securities Exchange Act of 1934, as amended, as soon as reasonably practicable after we electronically file such material with,\nor furnish it to, the Securities and Exchange Commission (“SEC”). Reports filed with the SEC also may be viewed at www.sec.gov.\nWe include our website throughout this report for reference only. The information contained on or connected to our website is not incorporated\nby reference into this report."}