{"url_path":"/sec/btcy/10-k/2026/item-1a","section_key":"item-1a","section_title":"Item 1A RISK FACTORS**","topic":"sec","document":{"doc_type":"10-K","doc_date":"2026-07-14","source_url":"https://www.sec.gov/Archives/edgar/data/1630113/0001493152-26-033207-index.html","accession_number":"0001493152-26-033207","cik":"0001630113","ticker":"BTCY","issuer_name":"BIOTRICITY INC.","edgar_url":"https://www.sec.gov/Archives/edgar/data/1630113/0001493152-26-033207-index.html","primary_entity_key":"0001630113","primary_entity_name":"BIOTRICITY INC."},"word_count":12473,"has_tables":true,"body_markdown":"**ITEM\n1A. RISK FACTORS**\n\n \n\n**Risks\nRelated to Our Business**\n\n \n\n**Natural\ndisasters and other events beyond our control could materially adversely affect us.**\n\n \n\nNatural\ndisasters or other catastrophic events may cause damage or disruption to our operations, international commerce and the global economy,\nand thus could have a strong negative effect on us. Our business operations are subject to interruption by natural disasters, fire, power\nshortages, pandemics and other events beyond our control. Such events could make it difficult or impossible for us to deliver our services\nto our customers and could decrease demand for our services. Pandemics or disease outbreaks such as COVID-19 and its variants (collectively,\n“COVID-19”) have had, and may continue to have, impacts on the Company’s business. These include, limited access to\nour facilities, customers, management, support staff and professional advisors and can, in future, impact our manufacturing supply chain.\nIn addition, the general economic and other impacts related to responsive actions taken by governments and others to mitigate the spread\nof COVID-19, or in the future other pandemics or disease outbreaks, including but not limited to stay-at-home, shelter-in-place and other\ntravel restrictions, social distancing requirements, mask mandates, limitations on certain businesses’ hours and operations, limits\non public gatherings and other events, and restrictions on what, may continue to, result in similar declines in store traffic and overall\ndemand, increased operating costs, and decreased or slower unit/store growth.\n\n** **\n\n**We\nhave a limited operating history upon which investors can rely to evaluate our future prospects.**\n\n \n\nWe\nhave a limited operating history upon which an evaluation of its business plan or performance and prospects can be made. The business\nand prospects of the Company must be considered in the light of the potential problems, delays, uncertainties and complications encountered\nin connection with a newly established business and new industry. The risks include, but are not limited to, the possibility that we\nwill not be able to develop functional and scalable products and services, or that although functional and scalable, our products and\nservices will not be economical to market; that our competitors hold proprietary rights that preclude us from marketing such products;\nthat our competitors market a superior or equivalent product; that we are not able to upgrade and enhance our technologies and products\nto accommodate new features and expanded service offerings; or the failure to receive necessary regulatory clearances for our products.\nTo successfully introduce and market our products at a profit, we must establish brand name recognition and competitive advantages for\nour products. There are no assurances that we can successfully address these challenges. If unsuccessful with one or more of these issues,\nwe and our business, financial condition and operating results could be materially and adversely affected.\n\n \n\nThe\ncurrent and future expense levels in our forecasts are based largely on estimates of planned operations and future revenues rather than\nexperience. It is difficult to accurately forecast future revenues because our business is new and our market has not been fully developed.\nIf our forecasts prove incorrect, the business, operating results and financial condition of the Company may be materially and adversely\naffected. Moreover, we may be unable to adjust our spending in a timely manner to compensate for any unanticipated reduction in revenues.\nAs a result, any significant reduction in revenues may immediately and adversely affect our business, financial condition and operating\nresults.\n\n \n\n**We\nhave not had a long history of producing revenues and we cannot predict when we will achieve sustained profitability.**\n\n \n\nWe\nhave not been profitable, and cannot definitely predict when we will achieve profitability, if ever. We have experienced net losses historically.\nWe do not anticipate generating significant revenues until we successfully continue to develop, commercialize and sell our existing and\nproposed products, of which we can give no assurance. We are unable to determine when we will generate significant revenues from the\nsale of new products. Our inability to become profitable may force us to curtail or temporarily discontinue our research and development\nprograms and our day-to-day operations. Furthermore, there can be no assurance that profitability, if achieved, can be sustained on an\nongoing basis. As of March 31, 2026, we had an accumulated deficit of $142,570,243.\n\n \n\n**We\nmay not meet our product development and commercialization milestones.**\n\n \n\nWe\nhave established milestones, based upon our expectations regarding our technologies at that time, which we use to assess our progress\ntoward developing our products. These milestones relate to technology and design improvements as well as dates for achieving development\ngoals. If our products exhibit technical defects or are unable to meet cost or performance goals, our commercialization schedule could\nbe delayed and potential purchasers of our initial commercial products may decline to purchase such products or may opt to pursue alternative\nproducts.\n\n \n\n17\n\n \n\n \n\nWe\nmay also experience shortages of monitors, sensors or bases due to manufacturing difficulties. Multiple suppliers provide the components\nused in our devices. Our manufacturing operations could be disrupted by fire, earthquake or other natural disaster, a labor-related disruption,\nfailure in supply or other logistical channels, electrical outages or other reasons. If there were a disruption to manufacturing facilities,\nwe would be unable to manufacture devices until we have restored and re-qualified our manufacturing capability or developed alternative\nmanufacturing facilities.\n\n \n\nGenerally,\nwe have met our milestone schedules when making technological advances in our product. We can give no assurance that our commercialization\nschedule will continue to be met as we further develop the Bioflux or any of our other proposed products.\n\n** **\n\n**We\nhave entered into a Credit Agreement pursuant to which we have granted the lender a security interest in all of our assets including\nour intellectual property and if we default on our obligations in the Credit Agreement the lender could foreclose on our assets.**\n\n \n\nOn\nDecember 21, 2021, we entered into a Credit Agreement (“Credit Agreement”) with SWK Funding LLC (“Lender’), wherein\nthe Company has borrowed $12.4 million, with a maturity date of December 21, 2026. Subsequent to an amendment during fiscal 2025, borrowings\nunder that facility amount to $14,45 million. The principal will accrue interest at the LIBOR Rate plus 10.5% (subject to adjustment\nas set forth in the Credit Agreement). Pursuant to the Credit Agreement, the Company will be required to make interest only payments\nfor the first 24 months (which may be extended to 36 months under prescribed circumstances), after which payments will include principal\namortization that accommodates a 40% balloon principal payment at maturity. Prepayment of amounts owing under the Credit Agreement are\nallowed under prescribed circumstances. Pursuant to the Credit Agreement the Company paid an Origination Fee in the amount of $120,000.\nBased on the Credit Agreement, upon Termination, the Company shall pay an Exit Fee of $1,425,000. \n\n \n\nThe\nCompany and Lender also entered into a Guarantee and Collateral Agreement wherein the Company agreed to secure the Credit Agreement with\nall of the Company’s assets. The Company and Lender also entered into an Intellectual Property Security Agreement dated December\n21, 2021 wherein the Credit Agreement is also secured by the Company’s right title and interest in the Company’s Intellectual\nProperty.\n\n \n\nIf\nwe default on our obligations to the lender, the lender could foreclose on their security interests and liquidate some or all of these\nassets, which would harm our business, financial condition and results of operations and could require us to curtail or cease operations.\n\n \n\n**Our\nbusiness is dependent upon physicians utilizing our solution when prescribing cardiac monitoring; if we fail to continue to be successful\nin convincing physicians in utilizing our solution, our revenue could fail to grow and could decrease.**\n\n \n\nThe\nsuccess of our cardiac monitoring business is dependent upon physicians utilizing our solution when prescribing cardiac monitoring to\ntheir patients. The utilization of our solution by physicians for use in the prescription of cardiac monitoring is directly influenced\nby a number of factors, including:\n\n \n\n \n●\nthe\nability of the physicians with whom we work to obtain sufficient reimbursement and be paid in a timely manner for the professional\nservices they provide in connection with the use of our monitoring solutions;\n\n \n \n \n\n \n●\ncontinuing\nto establish ourselves as a cardiac technology company;\n\n \n \n \n\n \n●\nour\nability to educate physicians regarding the benefits of COM over alternative diagnostic monitoring solutions;\n\n \n \n \n\n \n●\nour\ndemonstrating that our proposed products are reliable and supported by us in the field;\n\n \n \n \n\n \n●\nsupplying\nand servicing sufficient quantities of products directly or through marketing alliances; and\n\n \n \n \n\n \n●\npricing\nour devices and technology service fees in a medical device industry that is becoming increasingly price sensitive.\n\n \n\nIf\nwe are unable to drive physician utilization, revenue from the provision of our arrhythmia monitoring solutions could fail to grow or\neven potentially decrease.\n\n \n\n18\n\n \n\n \n\n**We\nare subject to extensive governmental regulations relating to the manufacturing, labeling and marketing of our products.**\n\n \n\nOur\nmedical technology products and operations are subject to regulation by the FDA, Health Canada and other foreign and local governmental\nauthorities. These agencies enforce laws and regulations that govern the development, testing, manufacturing, labeling, advertising,\nmarketing and distribution, and market surveillance of our medical products.\n\n \n\nUnder\nthe United States Federal Food, Drug, and Cosmetic Act, medical devices are classified into one of three classes — Class I, Class\nII or Class III — depending on the degree of risk associated with each medical device and the extent of control needed to ensure\nsafety and effectiveness. Our Bioflux device is a Class II medical device and we believe our planned products will also be Class II medical\ndevices. Class II devices are subject to additional controls, including full applicability of the Quality System Regulations, and requirements\nfor 510(k) pre-market notification.\n\n \n\nFrom\ntime to time, the FDA may disagree with the classification of a new Class II medical device and require the manufacturer of that device\nto apply for approval as a Class III medical device. In the event that the FDA determines that our Class II medical products should be\nclassified as Class III medical devices, we could be precluded from marketing the devices for clinical use within the United States for\na period of time, the length of which depends on the specific change in the classification. Reclassification of our Class II medical\nproducts as Class III medical devices could significantly increase our regulatory costs, including the timing and expense associated\nwith required clinical trials and other costs.\n\n \n\nIn\naddition to regulations in the United States, we will be subject to a variety of foreign regulations governing clinical trials and commercial\nsales and distribution of our products in foreign countries. Whether or not we obtain FDA approval for a product, we must obtain approval\nof a product by the comparable regulatory authorities of foreign countries before we can commence clinical trials or marketing of the\nproduct in those countries. The approval process varies from country to country, and the time may be longer or shorter than that required\nfor FDA approval. The requirements governing the conduct of clinical trials, product licensing, pricing and reimbursement vary greatly\nfrom country to country.\n\n \n\nThe\npolicies of the FDA and foreign regulatory authorities may change and additional government regulations may be enacted which could prevent\nor delay regulatory approval of our products and could also increase the cost of regulatory compliance. We cannot predict the likelihood,\nnature or extent of adverse governmental regulation that might arise from future legislative or administrative action, either in the\nUnited States or abroad.\n\n \n\nThe\nFDA and non-U.S. regulatory authorities require that our products be manufactured according to rigorous standards. These regulatory requirements\nmay significantly increase our production costs and may even prevent us from making our products in amounts sufficient to meet market\ndemand. If we change our approved manufacturing process, the FDA may need to review the process before it may be used. Failure to comply\nwith applicable regulatory requirements discussed could subject us to enforcement actions, including warning letters, fines, injunctions\nand civil penalties, recall or seizure of our products, operating restrictions, partial suspension or total shutdown of our production,\nand criminal prosecution.\n\n \n\nFederal,\nstate and non-U.S. regulations regarding the manufacture and sale of medical devices are subject to future changes. The complexity, timeframes\nand costs associated with obtaining marketing clearances are unknown. Although we cannot predict the impact, if any, these changes might\nhave on our business, the impact could be material.\n\n \n\nFollowing\nthe introduction of a product, these agencies will also periodically review our design and manufacturing processes and product performance.\nThe process of complying with the applicable good manufacturing practices, adverse event reporting, clinical trial and other requirements\ncan be costly and time consuming, and could delay or prevent the production, manufacturing or sale of our products. In addition, if we\nfail to comply with applicable regulatory requirements, it could result in fines, delays or suspensions of regulatory clearances, closure\nof manufacturing sites, seizures or recalls of products and damage to our reputation. Recent changes in enforcement practice by the FDA\nand other agencies have resulted in increased enforcement activity, which increases the compliance risk for the Company and other companies\nin our industry. In addition, governmental agencies may impose new requirements regarding registration, labeling or prohibited materials\nthat may require us to modify or re-register products already on the market or otherwise impact our ability to market our products in\nthose countries. Once clearance or approval has been obtained for a product, there is an obligation to ensure that all applicable FDA,\nHealth Canada and other regulatory requirements continue to be met.\n\n \n\nAdditionally,\ninjuries caused by the malfunction or misuse of cardiac monitoring devices, even where such malfunction or misuse occurs with respect\nto one of our competitor’s products, could cause regulatory agencies to implement more conservative regulations on the medical\ncardiac monitoring industry, which could significantly increase our operating costs.\n\n \n\n19\n\n \n\n \n\n**If\nour customers are not able to both obtain and maintain adequate levels of third-party reimbursement for services using our products,\nit would have a material adverse effect on our business.**\n\n \n\nHealthcare\nproviders and related facilities are generally reimbursed for their services through payment systems managed by various governmental\nagencies worldwide, private insurance companies, and managed care organizations. The manner and level of reimbursement in any given case\nmay depend on the site of care, the procedure(s) performed, the final patient diagnosis, the device(s) utilized, available budget, the\nefficacy, safety, performance and cost-effectiveness of our planned products and services, or a combination of these or other factors,\nand coverage and payment levels are determined at each payer’s discretion. The coverage policies and reimbursement levels of these\nthird-party payers may impact the decisions of healthcare providers and facilities regarding which medical products they purchase and\nthe prices they are willing to pay for those products. Thus, changes in reimbursement levels or methods may either positively or negatively\nimpact sales of our products.\n\n \n\nWe\nhave no direct control over payer decision-making with respect to coverage and payment levels for our medical device products. Additionally,\nwe expect many payers to continue to explore cost-containment strategies (e.g., comparative and cost-effectiveness analyses, so-called\n“pay-for-performance” programs implemented by various public and private payers, and expansion of payment bundling schemes\nsuch as Accountable Care Organizations, and other such methods that shift medical cost risk to providers) that may potentially impact\ncoverage and/or payment levels for our current products or products we develop.\n\n \n\nThe\nability of physicians and other providers to successfully utilize our cardiac monitoring solution and successfully allow payors to reimburse\nfor the physicians’ technical and professional fees is critical to our business because physicians and their patients will select\narrhythmia monitoring solutions other than ours in the event that payors refuse to adequately reimburse our technical fees and physicians’\nprofessional fees.\n\n \n\n**Our\ncustomers may experience difficulty in obtaining reimbursement for our services from commercial payors that consider our technology to\nbe experimental and investigational, which would adversely affect our revenue and operating results.**\n\n \n\nMany\ncommercial payors refuse to enter into contracts to reimburse the fees associated with medical devices or services that such payors determine\nto be “experimental and investigational.” Commercial payors typically label medical devices or services as “experimental\nand investigational” until such devices or services have demonstrated product superiority evidenced by a randomized clinical trial.\n\n \n\nClinical\ntrials have been performed on other mobile cardiac telemetry devices, proving higher diagnostic yield than traditional event loop monitoring.\nCertain remaining commercial payors, however, have stated that they do not believe the data from the clinical trials justifies the removal\nof the experimental designation for mobile cardiac telemetry solutions. As a result, certain commercial payors may refuse to reimburse\nthe technical and professional fees associated with cardiac monitoring solutions such as the one expected to be offered by Biotricity.\n\n \n\nIf\ncommercial payors decide not reimburse physicians or providers for their services during the utilization of our cardiac monitoring solutions,\nour revenue could fail to grow and could decrease.\n\n \n\n**Reimbursement\nby Medicare is highly regulated and subject to change; our failure to comply with applicable regulations, could decrease our expected\nrevenue and may subject us to penalties or have an adverse impact on our business.**\n\n \n\nThe\nMedicare program is administered by the Centers for Medicare and Medicaid Services (“CMS”), which imposes extensive and detailed\nrequirements on medical services providers, including, but not limited to, rules that govern how we structure our relationships with\nphysicians, and how and where we provide our arrhythmia monitoring solutions. Our failure to comply with applicable Medicare rules could\nresult in discontinuing the ability for physicians to receive reimbursement as they will likely utilize our cardiac monitoring solution\nunder the Medicare payment program, civil monetary penalties, and/or criminal penalties, any of which could have a material adverse effect\non our business and revenues.\n\n** **\n\n**Consolidation\nof commercial payors could result in payors eliminating coverage of mobile cardiac monitoring solutions or reducing reimbursement rates.**\n\n \n\nWhen\npayors combine their operations, the combined company may elect to reimburse physicians for cardiac monitoring services at the lowest\nrate paid by any of the participants in the consolidation. If one of the payors participating in the consolidation does not reimburse\nfor these services at all, the combined company may elect not to reimburse at any rate. Reimbursement rates tend to be lower for larger\npayors. As a result, as payors consolidate, our expected average reimbursement rate may decline.\n\n \n\n20\n\n \n\n \n\n**Product\ndefects could adversely affect the results of our operations.**\n\n \n\nThe\ndesign, manufacture and marketing of our products involve certain inherent risks. Manufacturing or design defects, unanticipated use\nof our products, or inadequate disclosure of risks relating to the use of our products can lead to injury or other adverse events. These\nevents could lead to recalls or safety alerts relating to our products (either voluntary or required by the FDA, Health Canada or similar\ngovernmental authorities in other countries), and could result, in certain cases, in the removal of a product from the market. A recall\ncould result in significant costs, as well as negative publicity and damage to our reputation that could reduce demand for our products.\nPersonal injuries relating to the use of our products could also result in product liability claims being brought against us. In some\ncircumstances, such adverse events could also cause delays in new product approvals.\n\n \n\n**Interruptions\nor delays in telecommunications systems or in the data services provided to us by cellular communication providers or the loss of our\nwireless or data services could impair the delivery of our cardiac monitoring services.**\n\n \n\nThe\nsuccess of Biotricity’s cardiac monitoring services will be dependent upon our ability to store, retrieve, process and manage data\nand to maintain and upgrade our data processing and communication capabilities. The monitoring solution relies on a third-party wireless\ncarrier to transmit data over its data network. All data sent by our monitors via this wireless data network or via landline is expected\nto be routed directly to data centers and subsequently routed to the third-party ECG monitoring centers. We are therefore dependent upon\nthird party wireless carrier to provide data transmission and data hosting services to us. If we lose wireless carrier services, we would\nbe forced to seek alternative providers of data transmission and data hosting services, which might not be available on commercially\nreasonable terms or at all.\n\n \n\nAs\nwe expand our commercial activities, an increased burden is expected to be placed upon our data processing systems and the equipment\nupon which they rely. Interruptions of our data networks, or the data networks of our wireless carrier, for any extended length of time,\nloss of stored data or other computer problems could have a material adverse effect on our business and operating results. Frequent or\npersistent interruptions in our arrhythmia monitoring services could cause permanent harm to our reputation and could cause current or\npotential users or prescribing physicians to believe that our systems are unreliable, leading them to switch to our competitors. Such\ninterruptions could result in liability, claims and litigation against us for damages or injuries resulting from the disruption in service.\n\n \n\nOur\nsystems are also expected to be vulnerable to damage or interruption from earthquakes, floods, fires, power loss, telecommunication failures,\nterrorist attacks, computer viruses, break-ins, sabotage, and acts of vandalism. Despite any precautions that we may take, the occurrence\nof a natural disaster or other unanticipated problems could result in lengthy interruptions in these services. We do not carry business\ninterruption insurance to protect against losses that may result from interruptions in service as a result of system failures. Moreover,\nthe communications and information technology industries are subject to rapid and significant changes, and our ability to operate and\ncompete is dependent on our ability to update and enhance the communication technologies used in our systems and services.\n\n \n\n**We\ncould be exposed to significant liability claims if we are unable to obtain insurance at acceptable costs and adequate levels or otherwise\nprotect ourselves against potential product liability claims.**\n\n \n\nThe\ntesting, manufacture, marketing and sale of medical devices entail the inherent risk of liability claims or product recalls. Product\nliability insurance is expensive and, if available, may not be available on acceptable terms at all periods of time. A successful product\nliability claim or product recall could inhibit or prevent the successful commercialization of our products, cause a significant financial\nburden on the Company, or both, which in either case could have a material adverse effect on our business and financial condition.\n\n \n\n**We\nrequire additional capital to support our present business plan and our anticipated business growth, and such capital may not be available\non acceptable terms, or at all, which would adversely affect our ability to operate.**\n\n \n\nWe\nwill require additional funds to further develop our business plan. Based on our current operating plans, we plan to use an additional\n$10 million in capital to fund our planned operations and sales efforts necessary to propel commercialization into broader US markets.\nWe may choose to raise additional capital beyond this in order to expedite and propel growth more rapidly. We can give no assurance that\nwe will be successful in raising any additional funds. Additionally, if we are unable to generate sufficient planned revenues from our\nsales and operating activities, we may need to raise additional funds, doing so through debt and equity offerings, in order to meet our\nexpected future liquidity and capital requirements, including capital required for the development completion and introduction of our\nother planned products and technologies. Any such financing that we undertake will likely be dilutive to current stockholders.\n\n \n\n21\n\n \n\n \n\nWe\nintend to continue to make investments to support our business growth, including patent or other intellectual property asset creation.\nIn addition, we may also need additional funds to respond to business opportunities and challenges, including our ongoing operating expenses,\nprotecting our intellectual property, satisfying debt payment obligations, developing new lines of business and enhancing our operating\ninfrastructure. While we may need to seek additional funding for such purposes, we may not be able to obtain financing on acceptable\nterms, or at all. In addition, the terms of our financings may be dilutive to, or otherwise adversely affect, holders of our common stock.\nWe may also seek to raise additional funds through arrangements with collaborators or other third parties. We may not be able to negotiate\nany such arrangements on acceptable terms, if at all. If we are unable to obtain additional funding on a timely basis, we may be required\nto curtail or terminate some or all of our business plans.\n\n \n\n**We\ncannot predict our future capital needs and we may not be able to secure additional financing.**\n\n \n\nWe\nwill need to raise additional funds in the future to fund our working capital needs and to fund further expansion of our business. We\nmay require additional equity or debt financings, collaborative arrangements with corporate partners or funds from other sources for\nthese purposes. No assurance can be given that necessary funds will be available for us to finance our development on acceptable terms,\nif at all. Furthermore, such additional financings may involve substantial dilution of our stockholders or may require that we relinquish\nrights to certain of our technologies or products. In addition, we may experience operational difficulties and delays due to working\ncapital restrictions. If adequate funds are not available from operations or additional sources of financing, we may have to delay or\nscale back our growth plans.\n\n \n\n**The\nresults of our research and development efforts are uncertain and there can be no assurance of the continued commercial success of our\nproducts.**\n\n \n\nWe\nbelieve that we will need to incur additional research and development expenditures to continue development of our existing proposed\nproducts as well as research and development expenditures to develop new products and services. The products and services we are developing\nand may develop in the future may not be technologically successful. In addition, the length of our product and service development cycle\nmay be greater than we originally expected, and we may experience delays in product development. If our resulting products and services\nare not technologically successful, they may not achieve market acceptance or compete effectively with our competitors’ products\nand services.\n\n \n\n**If\nwe fail to retain certain of our key personnel and attract and retain additional qualified personnel, we might not be able to pursue\nour growth strategy.**\n\n \n\nOur\nfuture success will depend upon the continued service of Waqaas Al-Siddiq, our President and Chief Executive Officer. We entered into\nan employment with Mr. Al-Siddiq on April 10, 2020 pursuant to which he will continue to serve as Chief Executive officer for 12 months\nfrom the execution date unless his employment is terminated sooner or the employment agreement is automatically renewed pursuant to its\nterms. Although we believe that our relationship with him is positive, there can be no assurance that his services will continue to be\navailable to us in the future. We do not carry any key man life insurance policies on any of our executive officers.\n\n \n\n**Executive\nand legislative actions, or legal proceedings that seek to amend or impede the implementation of the Affordable Care Act, as well as\nfuture efforts to repeal, replace or further modify the Affordable Care Act may adversely affect our business, financial condition and\nresults of operations.**\n\n \n\nSince\nits adoption into law in 2010, the Affordable Care Act has been challenged before the U.S. Supreme Court, and Congress in order to delay,\ndefund, or repeal implementation of or amend significant provisions of the Affordable Care Act. In addition, there continues to be ongoing\nlitigation over the interpretation and implementation of certain provisions of the law. The net effect of the Affordable Care Act, as\ncurrently in effect, on our business is subject to a number of variables, including the law’s complexity, lack of complete implementing\nregulations and interpretive guidance, and the sporadic implementation of the numerous programs designed to improve access to and the\nquality of healthcare services. Additional variables of the Affordable Care Act impacting our business will be how states, providers,\ninsurance companies, employers, and other market participants respond to any future challenges to the Affordable Care Act.\n\n \n\nWe\ncannot predict whether the Affordable Care Act will be modified, or whether it will be repealed or replaced, in whole or in part, and,\nif so, what the replacement plan or modifications would be, when the replacement plan or modifications would become effective, or whether\nany of the existing provisions of the Affordable Care Act would remain in place\n\n \n\n22\n\n \n\n \n\n**We\nwill not be profitable unless we can demonstrate that our products can be manufactured at low prices.**\n\n \n\nTo\ndate, we have focused primarily on research and development of the first and second generation of products, as well as other technologies\nwe plan to introduce in our eco-system, and their proposed marketing and distribution. Consequently, we have limited experience in manufacturing\nthese products on a commercial basis. We may manufacture our products through third-party manufacturers. We can offer no assurance that\neither we or our manufacturing partners will develop efficient, automated, low-cost manufacturing capabilities and processes to meet\nthe quality, price, engineering, design and production standards or production volumes required to successfully mass market our products,\nespecially at the low-cost levels we require to absorb the cost of near free distribution of our products pursuant to our proposed business\nplan. Even if we or our manufacturing partners are successful in developing such manufacturing capability and processes, we do not know\nwhether we or they will be timely in meeting our product commercialization schedule or the production and delivery requirements of potential\ncustomers. A failure to develop such manufacturing processes and capabilities could have a material adverse effect on our business and\nfinancial results.\n\n \n\nOur\nprofitability in part is dependent on material and other manufacturing costs. We are unable to offer any assurance that either we or\na manufacturing partner will be able to reduce costs to a level which will allow production of a competitive product or that any product\nproduced using lower cost materials and manufacturing processes will not suffer from a reduction in performance, reliability and longevity.\n\n \n\n**Significant\ndevelopments or changes in national laws or policies to protect or promote domestic interests and/or address foreign competition can\nhave an adverse effect on our business and financial statements.**\n\n \n\nSignificant\ndevelopments or changes in national laws or policies to protect or promote domestic interests and/or address foreign competition, including\nlaws and policies in areas such as trade, manufacturing, government purchasing, healthcare, intellectual property, regulatory enforcement\nand investment/development, can adversely affect our business and financial statements. The U.S. has announced and/or implemented significant\nnew tariffs on imports from a wide range of countries, which has prompted retaliatory tariffs by a number of countries and a cycle of\nretaliatory tariffs by both the U.S. and other countries. In early April 2025, actions were taken by the U.S. and certain other countries\nto delay the effective date of certain of these tariffs, but as of the date of this report a number of new tariffs remain in effect,\nincluding significant tariffs between the U.S. and China. Collectively, these tariffs increase the cost to us of supplies and components,\nwhich in turn will require us to implement surcharges and/or increase the price of certain of our products; can increase the cost to\nour customers of certain of our finished goods, which together with the surcharges and price increases noted above can adversely impact\ndemand for our products and our competitive positioning; could adversely impact the availability to us of certain products in certain\ncountries and disrupt our supply chains, with related impacts to our operations; and could exacerbate inflation, diminish investment\nand result in broader negative impacts, economic instability and capital markets dislocation that may adversely impact demand for our\nproducts. In addition, whenever we are unable to fully recover higher costs, or whenever there is a time delay between the increase in\ncosts and our ability to recover these costs, our margins and profitability can decline. The U.S. may implement additional tariffs and\nother measures, further retaliatory tariffs and other retaliatory actions may follow and the risks and adverse effects noted above may\nincrease. Though the risks identified above in certain cases have already adversely impacted part of our business, the full impact of\nthese tariffs and other actions on the Company and on our business partners remains highly uncertain and subject to rapid change. In\naddition, certain governments have implemented policies to induce “re-shoring” of supply chains, reduce reliance on imported\nsupplies and promote national production. For example, the Chinese government has issued a series of policies in the past several years\nto promote the development and use of local medical devices.\n\n \n\n**We\nare vulnerable to changes in political and economic conditions, including the effects of tariffs and/or international trade wars and\ndisruptions to remittances.**\n\n \n\nIn\nApril 2025, the U.S. government announced a baseline tariff of 10% on products from all countries and an additional individualized reciprocal\ntariff on the countries with which the United States has the largest trade deficits. The U.S. and/or countries into which we import merchandise\nand equipment may, in the future, adjust and/or impose new quotas, duties, tariffs or reciprocal tariffs or other restrictions which\nmay affect our operations and our ability to purchase imported merchandise at reasonable prices, which may negatively affect affordability\nto our Members. The ultimate impact of any tariffs will depend on various factors, including how long such tariffs remain in place, the\nultimate levels of such tariffs and how other countries respond to the U.S. tariffs. Our Miami Distribution Center, which operates within\na Free Trade Zone (“FTZ”), serves as a strategic mechanism for mitigating the economic risks posed by tariffs, but the use\nof the FTZ may not mitigate the impact of duties on items we purchase from U.S. vendors that are either imported finished goods or that\ncontain significant amounts of imported inputs. We may also choose to re-route merchandise directly from the country of origin directly\nto the markets where we have warehouse clubs to bypass the impact of U.S. tariffs. However, if we are unable to mitigate tariff-related\nrisks through supply chain adjustments, pricing strategies, or other measures, our financial performance and growth prospects could be\nnegatively affected.\n\n \n\n23\n\n \n\n \n\nRemittances\nmake up a significant portion of GDP in certain markets, including Guatemala, El Salvador, Nicaragua and Honduras. A remittance is a\ntransfer of money by a foreign worker to an individual in his or her home country. If deportations of these workers from the United States\nincreases, either due to changes in immigration policy, enforcement actions, or legal challenges, it could disrupt their ability to send\nmoney back to their families. Additionally, the financial strain of relocation and reintegration into their home countries may further\ndiminish workers’ disposable income and their ability to provide financial support. The resulting decline in remittance flows could\nhave a direct negative impact on the economies of several of the Latin American nations where we may operate, which rely on remittances\nas a key source of income and poverty alleviation for millions of families.\n\n \n\n**New\nor increased tariffs or other trade restrictions could have a material adverse effect on our business, financial condition, results of\noperations and cash flows.**\n\n \n\nWe\nare subject to tariffs and taxes in the United States and numerous foreign jurisdictions, and we may be subject to trade protection measures\nthat are being contemplated by the United States and other governments around the world, as well as potential disruptions in trade agreements,\nsuch as a possible amendment to or withdrawal from the USMCA and the exit of the United Kingdom from the EU. For example, during 2024\nthe United States announced increased tariffs on a Chinese-sourced component of certain of our products. While we have received an extension\non the effectiveness of such tariffs, we are exploring options to identify a longer-term solution to such tariffs (although there can\nbe no assurance that we will succeed in such efforts).\n\n \n\nIn\naddition, changes in the United States government following the 2024 presidential and congressional elections may result in significant\nchanges to United States trade policies and significantly increased tariffs on imported goods, and may cause other countries to react\nto such changes. Considerable uncertainty exists regarding tariff policy towards Mexico, Canada, China and other countries. On February\n1, 2025, President Trump announced the imposition of a 25% tariff on all goods imported from Mexico and Canada. Days later, President\nTrump suspended the imposition of such tariffs for a period of 30 days. Also in February 2025, President Trump imposed a 10% tariff on\ngoods imported from China, resulting in retaliatory tariffs imposed on United States exports to China. As of the date of this Form 10-K,\nit remains unclear whether additional new tariffs will be imposed on imported goods and, if so, at what level and for how long.\n\n \n\nFurthermore,\nPresident Trump has expressed his antipathy towards certain existing international trade agreements and organizations, including the\nUSMCA and the United States’ membership in the World Trade Organization (the “WTO”). An amendment to or the United\nStates’ withdrawal from the USMCA or the WTO could result in increased tariffs or other new trade restrictions on imports from\nMexico, Canada, China and other countries.\n\n \n\nThese\ndevelopments, measures and disruptions may result in new or higher tariffs, import-export restrictions and taxes. Changes in, or revised\ninterpretations of import-export laws or international trade agreements, along with new or increased tariffs, trade restrictions or taxation\non income earned or goods manufactured outside the United States may have a material adverse effect on our business, financial condition,\nresults of operations and cash flows.\n\n \n\n**If\nwe or our suppliers fail to achieve or maintain regulatory approval of manufacturing facilities, our growth could be limited, and our\nbusiness could be harmed.**\n\n \n\nWe\ncurrently assemble devices in our California facility. To maintain compliance with FDA and other regulatory requirements, our manufacturing\nfacilities must be periodically re-evaluated and qualified under a quality system to ensure they meet production and quality standards.\nSuppliers of components and products used to manufacture our devices must also comply with FDA regulatory requirements, which often require\nsignificant resources and subject us and our suppliers to potential regulatory inspections and stoppages. If we or our suppliers do not\nmaintain regulatory approval for our manufacturing operations, our business could be adversely affected.\n\n \n\n**Our\ndependence on a limited number of suppliers may prevent us from delivering our devices on a timely basis.**\n\n \n\nWe\ncurrently rely on a limited number of suppliers of components for our devices. If these suppliers became unable to provide components\nin the volumes needed or at an acceptable price, we would have to identify and qualify acceptable replacements from alternative sources\nof supply. The process of qualifying suppliers is lengthy. Delays or interruptions in the supply of our requirements could limit or stop\nour ability to provide sufficient quantities of devices on a timely basis or meet demand for our services, which could have a material\nadverse effect on our business, financial condition and results of operations.\n\n \n\n24\n\n \n\n \n\n**Our\noperations in international markets involve inherent risks that we may not be able to control.**\n\n \n\nOur\nbusiness plan includes the marketing and sale of our proposed products in international markets. Accordingly, our results could be materially\nand adversely affected by a variety of uncontrollable and changing factors relating to international business operations, including:\n\n \n\n \n●\nMacroeconomic\nconditions adversely affecting geographies where we intend to do business;\n\n \n \n \n\n \n●\nForeign\ncurrency exchange rates;\n\n \n \n \n\n \n●\nPolitical\nor social unrest or economic instability in a specific country or region;\n\n \n \n \n\n \n●\nHigher\ncosts of doing business in foreign countries;\n\n \n \n \n\n \n●\nInfringement\nclaims on foreign patents, copyrights or trademark rights;\n\n \n \n \n\n \n●\nDifficulties\nin staffing and managing operations across disparate geographic areas;\n\n \n \n \n\n \n●\nDifficulties\nassociated with enforcing agreements and intellectual property rights through foreign legal systems;\n\n \n \n \n\n \n●\nTrade\nprotection measures and other regulatory requirements, which affect our ability to import or export our products from or to various\ncountries;\n\n \n \n \n\n \n●\nAdverse\ntax consequences;\n\n \n \n \n\n \n●\nUnexpected\nchanges in legal and regulatory requirements;\n\n \n \n \n\n \n●\nMilitary\nconflict, terrorist activities, natural disasters and medical epidemics; and\n\n \n \n \n\n \n●\nOur\nability to recruit and retain channel partners in foreign jurisdictions.\n\n \n\n**Our\nexisting and future levels of indebtedness could adversely affect our financial health, ability to obtain financing in the future, ability\nto react to changes in our business and ability to fulfill our obligations under such indebtedness.**\n\n \n\nAs\nof March 31, 2026, in addition to our accounts payable, we had aggregate outstanding indebtedness of $26.7 million compared to $25.2\nmillion for the year ended March 31, 2025. This level of indebtedness could:\n\n \n\n \n●\nMake\nit more difficult for us to satisfy our obligations with respect to our outstanding notes and other indebtedness, resulting in possible\ndefaults on and acceleration of such indebtedness.\n\n \n●\nRequire\nus to dedicate a substantial portion of our cash flow from operations to the payment of principal and interest on our indebtedness,\nthereby reducing the availability of such cash flows to fund working capital, acquisitions, capital expenditures and other general\ncorporate purposes.\n\n \n●\nLimit\nour ability to obtain additional financing for working capital, acquisitions, capital expenditures, debt service requirements and\nother general corporate purposes.\n\n \n●\nLimit\nour ability to refinance indebtedness or cause the associated costs of such refinancing to increase.\n\n \n●\nIncrease\nour vulnerability to general adverse economic and industry conditions, including interest rate fluctuations (because our borrowings\nare at variable rates of interest); and\n\n \n●\nPlace\nus at a competitive disadvantage compared to our competitors with proportionately less debt or comparable debt at more favorable\ninterest rates which, as a result, may be better positioned to withstand economic downturns.\n\n** **\n\n**Our\nauditors have indicated doubt about our ability to continue as a going concern.**\n\n \n\nAs\nof March 31, 2026, the Company had $149,789 in cash, accumulated deficit of $142,570,243 and cash flow used in operations of $ 720,955\nfor the fiscal year then ended. The Company has incurred and expects to continue to incur significant costs in pursuit of its expansion\nand development plans. These conditions raise doubt about the Company’s ability to continue as a going concern and accordingly\nour auditors have included a going concern opinion in our annual report. Management has taken certain action and continues to implement\nchanges designed to improve the Company’s financial results and operating cash flows. The actions involve certain cost-saving initiatives\nand growing strategies, including (a) engage in very limited activities without incurring any liabilities that must be satisfied in cash;\nand (b) offer noncash consideration and seek equity lines as a means of financing its operations. Additionally, the Company’s plan\nincludes certain scheduled research and development activities and related clinical trials which may be deferred as needed. If the Company\nis unable to obtain revenue producing contracts or financing or if the revenue or financing it does obtain is insufficient to cover any\noperating losses it may incur, it may substantially curtail its operations or seek other business opportunities through strategic alliances,\nacquisitions or other arrangements that may dilute the interests of existing stockholders.\n\n \n\n25\n\n \n\n \n\n**Risks\nRelated to Our Industry**\n\n \n\n**The\nindustry in which we operate is highly competitive and subject to rapid technological change. If our competitors are better able to develop\nand market products that are safer, more effective, less costly, easier to use, or are otherwise more attractive, we may be unable to\ncompete effectively with other companies.**\n\n \n\nThe\nmedical technology industry is characterized by intense competition and rapid technological change, and we will face competition on the\nbasis of product features, clinical outcomes, price, services and other factors. Competitors may include large medical device and other\ncompanies, some of which have significantly greater financial and marketing resources than we do, and firms that are more specialized\nthan we are with respect to particular markets. Our competition may respond more quickly to new or emerging technologies, undertake more\nextensive marketing campaigns, have greater financial, marketing and other resources than ours or may be more successful in attracting\npotential customers, employees and strategic partners.\n\n \n\nOur\ncompetitive position will depend on multiple, complex factors, including our ability to achieve regulatory clearance and market acceptance\nfor our products, develop new products, implement production and marketing plans, secure regulatory approvals for products under development\nand protect our intellectual property. In some instances, competitors may also offer, or may attempt to develop, alternative systems\nthat may be delivered without a medical device or a medical device superior to ours. The development of new or improved products, processes\nor technologies by other companies may render our products or proposed products obsolete or less competitive. The entry into the market\nof manufacturers located in low-cost manufacturing locations may also create pricing pressure, particularly in developing markets. Our\nfuture success depends, among other things, upon our ability to compete effectively against current technology, as well as to respond\neffectively to technological advances or changing regulatory requirements, and upon our ability to successfully implement our marketing\nstrategies and execute our research and development plan. Our research and development efforts are aimed, in part, at solving increasingly\ncomplex problems, as well as creating new technologies, and we do not expect that all of our projects will be successful. If our research\nand development efforts are unsuccessful, our future results of operations could be materially harmed.\n\n \n\n**We\nface competition from other medical device companies that focus on similar markets.**\n\n \n\nWe\nface competition from other companies that have longer operating histories and may have greater name recognition and substantially greater\nfinancial, technical and marketing resources than us. Many of these companies also have FDA or other applicable governmental approval\nto market and sell their products, and more extensive customer bases, broader customer relationships and broader industry alliances than\nus, including relationships with many of our potential customers. Increased competition from any of these sources could result in our\nfailure to achieve and maintain an adequate level of customers and market share to support the cost of our operations.\n\n** **\n\n**Unsuccessful\nclinical or other trials or procedures relating to products under development could have a material adverse effect on our prospects.**\n\n \n\nThe\nregulatory approval process for new products and new indications for existing products requires extensive clinical trials and procedures,\nincluding early clinical experiences and regulatory studies. Unfavorable or inconsistent clinical data from current or future clinical\ntrials or procedures conducted by us, our competitors, or third parties, or perceptions regarding this clinical data, could adversely\naffect our ability to obtain necessary approvals and the market’s view of our future prospects. Such clinical trials and procedures\nare inherently uncertain and there can be no assurance that these trials or procedures will be completed in a timely or cost-effective\nmanner or result in a commercially viable product. Failure to successfully complete these trials or procedures in a timely and cost-effective\nmanner could have a material adverse effect on our prospects. Clinical trials or procedures may experience significant setbacks even\nafter earlier trials have shown promising results. Further, preliminary results from clinical trials or procedures may be contradicted\nby subsequent clinical analysis. In addition, results from our clinical trials or procedures may not be supported by actual long-term\nstudies or clinical experience. If preliminary clinical results are later contradicted, or if initial results cannot be supported by\nactual long-term studies or clinical experience, our business could be adversely affected. Clinical trials or procedures may be suspended\nor terminated by us, the FDA or other regulatory authorities at any time if it is believed that the trial participants face unacceptable\nhealth risks.\n\n \n\n26\n\n \n\n \n\n**Intellectual\nproperty litigation and infringement claims could cause us to incur significant expenses or prevent us from selling certain of our products.**\n\n \n\nThe\nmedical device industry in which we operate is characterized by extensive intellectual property litigation and, from time to time, we\nmight be the subject of claims by third parties of potential infringement or misappropriation. Regardless of outcome, such claims are\nexpensive to defend and divert the time and effort of our management and operating personnel from other business issues. A successful\nclaim or claims of patent or other intellectual property infringement against us could result in our payment of significant monetary\ndamages and/or royalty payments, or it could negatively impact our ability to sell current or future products in the affected category\nand could have a material adverse effect on business, cash flows, financial condition or results of operations.\n\n \n\n**If\nwe are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.**\n\n \n\nWe\nplan on relying on trade secrets, including unpatented know-how, technology and other proprietary information, to maintain our competitive\nposition. We will seek to protect these trade secrets, in part, by entering into non-disclosure and confidentiality agreements with parties\nwho have access to them, such as our employees, corporate collaborators, outside scientific collaborators, contract manufacturers, consultants,\nadvisors and other third parties. We will seek to protect our confidential proprietary information, in part, by entering into confidentiality\nand invention or intellectual property assignment agreements with our employees and consultants. Moreover, to the extent we enter into\nsuch agreements, any of these parties may breach the agreements and disclose our proprietary information, including our trade secrets,\nand we may not be able to obtain adequate remedies for such breaches. Enforcing a claim that a party illegally disclosed or misappropriated\na trade secret is difficult, expensive and time-consuming, and the outcome is unpredictable. In addition, some courts inside and outside\nthe United States are less willing or unwilling to protect trade secrets. If any of our trade secrets were to be lawfully obtained or\nindependently developed by a competitor, we would have no right to prevent them, or those to whom they communicate it, from using that\ntechnology or information to compete with us. If any of our trade secrets were to be disclosed to or independently developed by a competitor,\nour competitive position would be harmed. In general, any loss of trade secret protection or other unpatented proprietary rights could\nharm our business, results of operations and financial condition.\n\n \n\n**If\nwe are unable to protect our proprietary rights, or if we infringe on the proprietary rights of others, our competitiveness and business\nprospects may be materially damaged.**\n\n \n\nWe\nhave filed for one industrial design patent in Canada and in the U.S. We may continue to seek patent protection for our designs and may\nseek patent protection for our proprietary technology if warranted. Seeking patent protection is a lengthy and costly process, and there\ncan be no assurance that patents will be issued from any pending applications, or that any claims allowed from existing or pending patents\nwill be sufficiently broad or strong to protect our designs or our proprietary technology. There is also no guarantee that any patents\nwe hold will not be challenged, invalidated or circumvented, or that the patent rights granted will provide competitive advantages to\nus. Our competitors have developed and may continue to develop and obtain patents for technologies that are similar or superior to our\ntechnologies. In addition, the laws of foreign jurisdictions in which we develop, manufacture or sell our products may not protect our\nintellectual property rights to the same extent, as do the laws of Canada or the United States.\n\n \n\nAdverse\noutcomes in current or future legal disputes regarding patent and other intellectual property rights could result in the loss of our\nintellectual property rights, subject us to significant liabilities to third parties, require us to seek licenses from third parties\non terms that may not be reasonable or favorable to us, prevent us from manufacturing, importing or selling our products, or compel us\nto redesign our products to avoid infringing third parties’ intellectual property. As a result, we may be required to incur substantial\ncosts to prosecute, enforce or defend our intellectual property rights if they are challenged. Any of these circumstances could have\na material adverse effect on our business, financial condition and resources or results of operations.\n\n \n\n**Dependence\non our proprietary rights and failing to protect such rights or to be successful in litigation related to such rights may result in our\npayment of significant monetary damages or impact offerings in our product portfolios.**\n\n \n\nOur\nlong-term success largely depends on our ability to market technologically competitive products. If we fail to obtain or maintain adequate\nintellectual property protection, we may not be able to prevent third parties from using our proprietary technologies or may lose access\nto technologies critical to our products. Also, our currently pending industrial design patent or any future patents applications may\nnot result in issued patents, and issued patents are subject to claims concerning priority, scope and other issues.\n\n \n\n27\n\n \n\n \n\nFurthermore,\nto the extent we do not file applications for patents domestically or internationally, we may not be able to prevent third parties from\nusing our proprietary technologies or may lose access to technologies critical to our products in other countries.\n\n \n\n**Enforcement\nof federal and state laws regarding privacy and security of patient information may adversely affect our business, financial condition\nor operations.**\n\n \n\nThe\nuse and disclosure of certain health care information by health care providers and their business associates have come under increasing\npublic scrutiny. Recent federal standards under the Health Insurance Portability and Accountability Act of 1996, or HIPAA, establish\nrules concerning how individually identifiable health information may be used, disclosed and protected. Historically, state law has governed\nconfidentiality issues, and HIPAA preserves these laws to the extent they are more protective of a patient’s privacy or provide\nthe patient with more access to his or her health information. As a result of the implementation of the HIPAA regulations, many states\nare considering revisions to their existing laws and regulations that may or may not be more stringent or burdensome than the federal\nHIPAA provisions. We must operate our business in a manner that complies with all applicable laws, both federal and state, and that does\nnot jeopardize the ability of our customers to comply with all applicable laws. We believe that our operations are consistent with these\nlegal standards. Nevertheless, these laws and regulations present risks for health care providers and their business associates that\nprovide services to patients in multiple states. Because these laws and regulations are recent, and few have been interpreted by government\nregulators or courts, our interpretations of these laws and regulations may be incorrect. If a challenge to our activities is successful,\nit could have an adverse effect on our operations, may require us to forego relationships with customers in certain states and may restrict\nthe territory available to us to expand our business. In addition, even if our interpretations of HIPAA and other federal and state laws\nand regulations are correct, we could be held liable for unauthorized uses or disclosures of patient information as a result of inadequate\nsystems and controls to protect this information or as a result of the theft of information by unauthorized computer programmers who\npenetrate our network security. Enforcement of these laws against us could have a material adverse effect on our business, financial\ncondition and results of operations.\n\n \n\n**We\nmay become subject, directly or indirectly, to federal and state health care fraud and abuse laws and regulations and if we are unable\nto fully comply with such laws, the Company could face substantial penalties.**\n\n \n\nAlthough\nnot affected at this time, our operations may in the future become directly or indirectly affected by various broad state and federal\nhealth care fraud and abuse laws, including the Federal Healthcare Programs’ Anti-Kickback Statute and the Stark law, which among\nother things, prohibits a physician from referring Medicare and Medicaid patients to an entity with which the physician has a financial\nrelationship, subject to certain exceptions. If our future operations are found to be in violation of these laws, we or our officers\nmay be subject to civil or criminal penalties, including large monetary penalties, damages, fines, imprisonment and exclusion from Medicare\nand Medicaid program participation. If enforcement action were to occur, our business and results of operations could be adversely affected.\n\n \n\n**We\nmay be subject to federal and state false claims laws which impose substantial penalties.**\n\n \n\nMany\nof the physicians and patients whom we expect to use our services will file claims for reimbursement with government programs such as\nMedicare and Medicaid. As a result, we may be subject to the federal False Claims Act if we knowingly “cause” the filing\nof false claims. Violations may result in substantial civil penalties, including treble damages. The federal False Claims Act also contains\n“whistleblower” or “qui tam” provisions that allow private individuals to bring actions on behalf of the government\nalleging that the defendant has defrauded the government. In recent years, the number of suits brought in the medical industry by private\nindividuals has increased dramatically. Various states have enacted laws modeled after the federal False Claims Act, including “qui\ntam” provisions, and some of these laws apply to claims filed with commercial insurers. We are unable to predict whether we could\nbe subject to actions under the federal False Claims Act, or the impact of such actions. However, the costs of defending claims under\nthe False Claims Act, as well as sanctions imposed under the False Claims Act, could adversely affect our results of operations.\n\n \n\n**Changes\nin the health care industry or tort reform could reduce the number of arrhythmia monitoring solutions ordered by physicians, which could\nresult in a decline in the demand for our planned solutions, pricing pressure and decreased revenue.**\n\n \n\nChanges\nin the health care industry directed at controlling health care costs or perceived over-utilization of arrhythmia monitoring solutions\ncould reduce the volume of solutions ordered by physicians. If more health care cost controls are broadly instituted throughout the health\ncare industry, the volume of cardiac monitoring solutions could decrease, resulting in pricing pressure and declining demand for our\nplanned services, which could harm our operating results. In addition, it has been suggested that some physicians order arrhythmia monitoring\nsolutions, even when the services may have limited clinical utility, primarily to establish a record for defense in the event of a claim\nof medical malpractice against the physician. Legal changes increasing the difficulty of initiating medical malpractice cases, known\nas tort reform, could reduce the amount of our services prescribed as physicians respond to reduced risks of litigation, which could\nharm our operating results.\n\n \n\n28\n\n \n\n \n\n**Risks\nRelated to Our Securities and Other Risks**\n\n \n\n**There\nis a limited existing market for our common stock and we do not know if a more liquid market for our common stock will develop to provide\nyou with adequate liquidity.**\n\n \n\nWe\ncannot assure you that a more active trading market for our common stock will develop or if it does develop, that it will be maintained.\nYou may not be able to sell your securities quickly or at the market price if trading in our securities is not active. In the absence\nof an active public trading market:\n\n \n\n \n●\nyou\nmay not be able to resell your securities at or above the public offering price;\n\n \n●\nthe\nmarket price of our common stock may experience more price volatility; and\n\n \n●\nthere\nmay be less efficiency in carrying out your purchase and sale orders.\n\n \n\n**The\nmarket price of our common stock may be volatile.**\n\n \n\nThe\nmarket price for our common stock may be volatile and subject to wide fluctuations in response to factors including the following:\n\n \n\n \n●\nOur\nability to successfully bring any of our proposed or planned products to market;\n\n \n \n \n\n \n●\nActual\nor anticipated fluctuations in our quarterly or annual operating results;\n\n \n \n \n\n \n●\nChanges\nin financial or operational estimates or projections;\n\n \n \n \n\n \n●\nConditions\nin markets generally;\n\n \n \n \n\n \n●\nChanges\nin the economic performance or market valuations of companies similar to ours;\n\n \n \n \n\n \n●\nAnnouncements\nby us or our competitors of new products, acquisitions, strategic partnerships, joint ventures or capital commitments;\n\n \n \n \n\n \n●\nOur\nintellectual property position; and\n\n \n \n \n\n \n●\nGeneral\neconomic or political conditions in the United States or elsewhere.\n\n \n\nIn\naddition, the securities market has from time to time experienced significant price and volume fluctuations that are not related to the\noperating performance of particular companies. These market fluctuations may also materially and adversely affect the market price of\nshares of our common stock.\n\n \n\n**There\nmay be a significant number of shares of common stock eligible for sale, which could depress the market price of such stock.**\n\n \n\nWe\nhave 29,402,934 outstanding shares as of June 20, 2026, of which 13,940,360 are unrestricted shares of common stock, such that a large\nnumber of shares of our common stock could be made available for sale in the public market, which could harm the market price of the\nstock. We also have 160,672 Exchangeable Shares, directly exchangeable into an equivalent number of shares of common stock, which could\nbe exchanged and made available for sale in public markets,\n\n \n\n**Our\nlargest stockholder will substantially influence our Company for the foreseeable future, including the outcome of matters requiring shareholder\napproval and such control may prevent you and other stockholders from influencing significant corporate decisions and may result in conflicts\nof interest that could cause the Company’s stock price to decline.**\n\n \n\nMr.\nAl-Siddiq, our chief executive officer and a member of our board of directors, beneficially owns approximately 7.21 % of our outstanding\nshares of common stock and common stock underlying the Exchangeable Shares. As a result, coupled with his board seat, he will have the\nability to influence the election of our directors and the outcome of corporate actions requiring shareholder approval, such as: (i)\na merger or a sale of our Company, (ii) a sale of all or substantially all of our assets, and (iii) amendments to our articles of incorporation\nand bylaws. This concentration of voting power and control could have a significant effect in delaying, deferring or preventing an action\nthat might otherwise be beneficial to our other shareholders and be disadvantageous to our shareholders with interests different from\nthose entities and individuals. Mr. Al-Siddiq also has significant control over our business, policies and affairs as an executive officer\nor director of our Company. He may also exert influence in delaying or preventing a change in control of the Company, even if such change\nin control would benefit the other stockholders of the Company. In addition, the significant concentration of stock ownership may adversely\naffect the market value of the Company’s common stock due to investors’ perception that conflicts of interest may exist or\narise.\n\n \n\n29\n\n \n\n \n\n**Failure\nto maintain effective internal control over our financial reporting in accordance with Section 404 of the Sarbanes-Oxley Act of 2002\n(“Sarbanes-Oxley Act”) could cause our financial reports to be inaccurate.**\n\n \n\nWe\nare required pursuant to Section 404 of the Sarbanes-Oxley Act to maintain internal control over financial reporting and to assess and\nreport on the effectiveness of those controls. This assessment includes disclosure of any material weaknesses identified by our management\nin our internal control over financial reporting. Although we prepare our financial statements in accordance with accounting principles\ngenerally accepted in the United States, our internal accounting controls may not meet all standards applicable to companies with publicly\ntraded securities. If we fail to implement any required improvements to our disclosure controls and procedures, we may be obligated to\nreport control deficiencies and our independent registered public accounting firm may not be able to certify the effectiveness of our\ninternal controls over financial reporting. In either case, we could become subject to regulatory sanction or investigation. Further,\nthese outcomes could damage investor confidence in the accuracy and reliability of our financial statements.\n\n \n\nOur\nmanagement has concluded that our internal controls over financial reporting were, and continue to be, effective, as of March 31, 2026.\nIf we are not able to maintain effective internal control over financial reporting, our financial statements, including related disclosures,\nmay be inaccurate, which could have a material adverse effect on our business.\n\n** **\n\n**Our\nissuance of additional common stock or preferred stock may cause our common stock price to decline, which may negatively impact your\ninvestment.**\n\n \n\nIssuances\nof a substantial number of additional shares of our common or preferred stock, or the perception that such issuances could occur, may\ncause prevailing market prices for our common stock to decline. In addition, our board of directors is authorized to issue additional\nseries of shares of preferred stock without any action on the part of our stockholders. Our board of directors also has the power, without\nstockholder approval, to set the terms of any such series of shares of preferred stock that may be issued, including voting rights, conversion\nrights, dividend rights, preferences over our common stock with respect to dividends or if we liquidate, dissolve or wind up our business\nand other terms. If we issue cumulative preferred stock in the future that has preference over our common stock with respect to the payment\nof dividends or upon our liquidation, dissolution or winding up, or if we issue preferred stock with voting rights that dilute the voting\npower of our common stock, the market price of our common stock could decrease.\n\n \n\n**Anti-takeover\nprovisions in the Company’s charter and bylaws may prevent or frustrate attempts by stockholders to change the board of directors\nor current management and could make a third-party acquisition of the Company difficult.**\n\n \n\nThe\nCompany’s certificate of incorporation and bylaws contain provisions that may discourage, delay or prevent a merger, acquisition\nor other change in control that stockholders may consider favorable, including transactions in which stockholders might otherwise receive\na premium for their shares. For example, our Certificate of Incorporation permits the Board of Directors without stockholder approval\nto issue up to 10,000,000 shares of preferred stock (20,000 of these shares have been designated as Series A Preferred, of which 6,305\nare outstanding, 600 of these shares have been designated as Series B Preferred, of which 265 are outstanding, and one special voting\npreferred share is designated and outstanding) and to fix the designation, power, preferences, and rights of the shares and preferred\nstock. Furthermore, the Board of Directors has the ability to increase the size of the Board and fill newly created vacancies without\nstockholder approval. These provisions could limit the price that investors might be willing to pay in the future for shares of the Company’s\ncommon stock.\n\n \n\n**Our\ncommon stock could become subject to the SEC’s penny stock rules and accordingly, broker-dealers may experience difficulty in completing\ncustomer transactions and trading activity in our securities may be adversely affected.**\n\n \n\nThe\nSEC has adopted regulations, which generally define “penny stock” to be an equity security that has a market price of less\nthan $5.00 per share, subject to specific exemptions. The market price of our common stock is less than $5.00 per share and therefore\nwould be a “penny stock” according to SEC rules, unless we are listed on a national securities exchange. Under these rules,\nbroker-dealers who recommend such securities to persons other than institutional accredited investors must:\n\n \n\n●\nMake a special written suitability determination for the purchaser;\n\n \n\n●\nReceive the purchaser’s prior written agreement to the transaction;\n\n \n\n●\nProvide the purchaser with risk disclosure documents which identify certain risks associated with investing in “penny stocks”\nand which describe the market for these “penny stocks” as well as a purchaser’s legal remedies; and\n\n \n\n●\nObtain a signed and dated acknowledgment from the purchaser demonstrating that the purchaser has actually received the required risk\ndisclosure document before a transaction in a “penny stock” can be completed.\n\n \n\n30\n\n \n\n \n\nIf\nour common stock became subject to these rules, broker-dealers may find it difficult to effectuate customer transactions and trading\nactivity in our securities may be adversely affected. As a result, the market price of our securities may be depressed, and you may find\nit more difficult to sell your securities.\n\n \n\n**We\nhave not paid dividends in the past and do not expect to pay dividends in the future, and any return on investment may be limited to\nthe value of our stock.**\n\n \n\nWe\nhave never paid any cash dividends on our common stock and do not anticipate paying any cash dividends on our common stock in the foreseeable\nfuture and any return on investment may be limited to the value of our common stock. We plan to retain any future earning to finance\ngrowth.\n\n \n\n**Risks\nRelated to Intellectual Property**\n\n \n\n**We\nhave no utility patent protection, and have only limited design patent protection and rely on unregistered copyright and trade secret\nprotection, if we are unable to obtain and maintain patent protection for our products, our competitors could develop and commercialize\nproducts and technology similar or identical to ours, and our ability to successfully commercialize our existing products and any products\nwe may develop, and our technology may be adversely affected.**\n\n \n\n**Any\nfailure to obtain or maintain sufficient intellectual property protection with respect to our current and planned products could have\na material adverse effect on our business, financial condition, and results of operations.**\n\n \n\nWe\nrely on trade secret protection to protect proprietary know-how that may not be patentable or that we elect not to patent, processes\nfor which patents may be difficult to obtain or enforce, and any other elements of our products and services that involve proprietary\nknow-how, information or technology that is not covered by patents. However, trade secrets can also be difficult to protect. If the steps\ntaken to maintain our trade secrets are deemed inadequate, we may have insufficient recourse against third parties for misappropriating\nany trade secrets. Misappropriation or unauthorized disclosure of our trade secrets could significantly affect our competitive position\nand may have a material adverse effect on our business. Furthermore, trade secret protection does not prevent competitors from independently\ndeveloping similar technology. To the extent we also rely on copyright protection, it, too, does not prevent competitors from independently\ndeveloping similar technology.\n\n \n\nEven\nif we were to obtain additional patent protection, such patents may not issue in a form that will provide us with any meaningful protection,\nprevent competitors or other third parties from competing with us, or otherwise provide us with any competitive advantage. Any patents\nthat we own may be challenged, narrowed, circumvented, or invalidated by third parties. Consequently, we do not know whether our products\nwill be protectable or remain protected by valid and enforceable patents. Our competitors or other third parties may be able to circumvent\nour intellectual property by developing similar or alternative technologies or products in a non-infringing manner which could materially\nadversely affect our business, financial condition, results of operations and prospects.\n\n \n\nThe\nCompany has made and will continue to make decisions regarding what patents and trademarks and other intellectual property to pursue\nand maintain in is business judgment balanced against the cost of obtaining and maintaining that IP.\n\n \n\n**We\nmay not be able to protect our intellectual property and proprietary rights throughout the world.**\n\n \n\nThird\nparties may attempt to commercialize competitive products or services in foreign countries where we do not have any patents or patent\napplications where legal recourse may be limited. This may have a significant commercial impact on our foreign business operations.\n\n \n\n**We\nmay become involved in intellectual property litigation either due to claims by others that we are infringing their intellectual property\nrights or due to our own assertions that others are infringing upon our intellectual property rights.**\n\n \n\n**We\nhave not done any investigation of and thus cannot provide assurance that our products or methods do not infringe the patents or other\nintellectual property rights of third parties.**\n\n \n\nIf\nour business is successful, the possibility may increase that others will assert infringement claims against us.\n\n \n\n31\n\n \n\n \n\nInfringement\nand other intellectual property claims and proceedings brought against us, whether successful or not, could result in substantial costs\nand harm to our reputation. Such claims and proceedings can also distract and divert management and key personnel from other tasks important\nto the success of the business. We cannot be certain that we will successfully defend against allegations of infringement of patents\nand intellectual property rights of others. In the event that we become subject to a patent infringement or other intellectual property\nlawsuit and if the other party’s patents or other intellectual property were upheld as valid and enforceable and we were found\nto infringe the other party’s patents or violate the terms of a license to which we are a party, we could be required to do one\nor more of the following:\n\n \n\n \n●\ncease\nselling or using any of our products that incorporate the asserted intellectual property, which would adversely affect our revenue;\n\n \n●\npay\nsubstantial damages for past use of the asserted intellectual property;\n\n \n●\nobtain\na license from the holder of the asserted intellectual property, which license may not be available on reasonable terms, if at all,\nand which could reduce profitability; and\n\n \n●\nredesign\nor rename, in the case of trademark claims, our products to avoid violating or infringing the intellectual property rights of third\nparties, which may not be possible and could be costly and time-consuming if it is possible to do so.\n\n \n\nThird-party\nclaims of intellectual property infringement, misappropriation or other violation against may also prevent or delay the sale and marketing\nof our products.\n\n \n\n**We\nmay also be subject to claims that our employees, consultants or advisors have wrongfully used or disclosed alleged trade secrets of\ntheir current or former employers or claims asserting ownership of what we regard as our own intellectual property.**\n\n \n\nIf\nwe fail in defending any such claims, it could have a material adverse effect on our business, financial condition, and results of operations.\nEven if we are successful in defending against such claims, litigation could result in substantial costs to us and be a distraction to\nmanagement.\n\n \n\n**If\nour trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our markets of interest\nand our business may be adversely affected. None identified.**\n\n \n\nOur\ntrademarks or trade names may be challenged, infringed, circumvented or declared generic or determined to be violating or infringing\non other marks. We may not be able to protect our rights to these trademarks and trade names, which we need to build name recognition\namong potential partners or customers in our markets of interest. At times, competitors or other third parties may adopt trade names\nor trademarks similar to ours, thereby impeding our ability to build brand identity and possibly leading to market confusion. In addition,\nthere could be potential trade name or trademark infringement or dilution claims brought by owners of other trademarks. Over the long\nterm, if we are unable to establish name recognition based on our trademarks and trade names, then we may not be able to compete effectively\nand our business may be adversely affected. Our efforts to enforce or protect our proprietary rights related to trademarks, trade secrets,\ndomain names, copyrights or other intellectual property may be ineffective and could result in substantial costs and diversion of resources\nand could adversely affect our business, financial condition, and results of operations."}