Risk Factors Dashboard
Once a year, publicly traded companies issue a comprehensive report of their business, called a 10-K. A component mandated in the 10-K is the ‘Risk Factors’ section, where companies disclose any major potential risks that they may face. This dashboard highlights all major changes and additions in new 10K reports, allowing investors to quickly identify new potential risks and opportunities.
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Risk Factors - STME
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There is a high degree of risk associated with buying the Company’s common stock. Prospective investors should carefully read this Annual Report on Form 10-K and consider the following risk factors when deciding whether to purchase the Company’s shares. These are speculative stocks and should be purchased by only those who can afford to lose their entire investment.
The risk factors outlined below are some of the known, substantial, material and potential risks that could adversely affect the Company’s business, financial condition, operating results and common share value. The Company cannot assure that it will successfully address these or any unknown risks and a failure to do so can have a negative impact on the individual investment. The Company may encounter risks in addition to those described below. Additional risks and uncertainties not currently known, or that are currently deemed to be immaterial, may also impair or adversely affect the business, financial condition or results of operations of the Company.
Risks Associated with the Company and Industry it Operates in
The Company operates in a highly competitive market. The Company faces competition from large, well established medical device manufacturers and pharmaceutical companies in the market for treatment of pain and management of diabetes and related ailments. Many of these companies are very well accepted by health practitioners and have significant resources, and the Company may not be able to compete effectively.
The market for treatment and management of diabetes and related ailments is intensely competitive, subject to rapid change and significantly affected by new product introductions. The Company competes indirectly with pharmaceutical and medical device companies, such as Bayer Corp., Becton Dickinson Corp., LifeScan Inc., a division of Johnson & Johnson, the MediSense Inc., and TheraSense Inc. These competitors’ products are based on traditional healthcare model and are well accepted by health practitioners and patients. If these companies decide to penetrate the Company’s target market they could threaten its position in the market.
The Company is subject to numerous governmental regulations which can increase its costs of developing the eBalance® Technology and products based on this technology.
The Company’s products are subject to rigorous regulation by the FDA, Health Canada and numerous international, supranational, federal, and state authorities. The process of obtaining regulatory approvals to market a medical device can be costly and time-consuming, and approvals may not be granted for future products, or additional indications or uses of existing products, on a timely basis, if at all. Delays in the receipt of, or failure to obtain approvals for, the Company’s products, or new indications and uses, could result in delayed realization of product revenues, reduction in revenues, and in substantial additional costs. In addition, no assurance can be given that the Company will remain in compliance with applicable FDA, Health Canada and other regulatory requirements once approval or marketing authorization has been obtained for a product. These requirements include, among other things, regulations regarding manufacturing practices, product labeling, advertising, and post-marketing reporting, including adverse event reports and field alerts due to manufacturing quality concerns.
Changes in the health care regulatory environment may adversely affect the Company’s business.
A number of the provisions of the U.S. Patient Protection and Affordable Care Act and the Health Care and Education Reconciliation Act of 2010 and its amendments changed access to health care products and services and established new fees for the medical device industry. Future rulemaking could increase rebates, reduce prices or the rate of price increases for health care products and services, or require additional reporting and disclosure. The Company cannot predict the timing or impact of any future rulemaking.
Inability to protect and enforce the Company’s intellectual property rights could adversely affect its financial results.
Intellectual property rights, including patents, trade secrets, confidential information, trademarks, tradenames, and other forms of trade dress, are important to the Company’s business. An inability to defend, protect and enforce its intellectual property rights could adversely affect the financial results, even if the Company is successful in developing and marketing products based on the eBalance® Technology. In addition, an adverse outcome in any litigation or interference proceeding could subject the Company to significant liabilities to third parties and require the Company to cease using the technology that is at issue or to license the technology from third parties. In addition, a finding that
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any of the Company’s intellectual property rights are invalid could allow the Company’s competitors to compete more easily and cost-effectively. Thus, an unfavorable outcome in any patent litigation or interference proceeding could have a material adverse effect on the Company’s business, financial condition, or results of operations.
The cost to the Company of any patent litigation or interference proceeding could be substantial. Uncertainties resulting from the initiation and continuation of patent litigation or interference proceedings could have a material adverse effect on the Company’s ability to compete in the marketplace. Patent litigation and interference proceedings could also absorb significant management time.
Competitors’ intellectual property may prevent the Company from selling its products or have a material adverse effect on its future profitability and financial condition.
Competitors may claim that the Company’s technology infringes upon their intellectual property. Resolving an intellectual property infringement claim can be costly and time consuming and may require the Company to enter into license agreements. The Company cannot guarantee that it would be able to obtain license agreements on commercially reasonable terms. A successful claim of patent or other intellectual property infringement could subject the Company to significant damages or an injunction preventing the manufacture, sale or use of its product. Any of these events could have a material adverse effect on the profitability and financial condition of the Company.
The Company’s research and development efforts may not result in the development of commercially successful products based on its eBalance® Technology, which may hinder its profitability and future growth.
The Company plans to continue to further research the eBalance® Technology and develop products based on the Technology. In order to develop commercially marketable products, the Company will be required to commit substantial efforts, funds, and other resources to research and development. A high rate of failure is inherent in the research and development of new products and technologies. The Company must make ongoing substantial expenditures without any assurance that its efforts will be commercially successful.
Failure can occur at any point in the process, including after significant funds have been invested. Planned products may fail to reach the market or may only have limited commercial success because of efficacy or safety concerns, failure to achieve positive clinical outcomes, inability to obtain necessary regulatory approvals, limited scope of approved uses, excessive costs to manufacture, the failure to establish or maintain intellectual property rights, or infringement of the intellectual property rights of others.
Even if the Company successfully develops marketable products or commercially develop its current Technology, it may be quickly rendered obsolete by changing customer preferences, changing industry standards, or competitors’ innovations.
Innovations may not be accepted quickly in the marketplace because of, among other things, entrenched patterns of clinical practice or uncertainty over third-party reimbursement. The Company cannot state with certainty when or whether its products under development will be launched, whether it will be able to develop, license, or otherwise acquire new products, or whether any products will be commercially successful. Failure to launch successful new products or new indications for existing products may cause the Company’s products to become obsolete, causing its revenues and operating results to suffer.
New products and technological advances by the Company’s competitors may negatively affect its results of operations.
The Company’s products face intense competition from its competitors. Competitors’ products may be safer, more effective, more effectively marketed or sold, or have lower prices or superior performance features than the Company’s products. The Company cannot predict with certainty the timing or impact of the introduction of competitors’ products.
Significant safety concerns could arise for the Company’s products, which could have a material adverse effect on its revenues and financial condition.
Health care products typically receive regulatory approval based on data obtained in controlled clinical trials of limited duration. Following regulatory approval, these products will be used over longer periods of time in many patients. Investigators may also conduct additional, and perhaps more extensive, studies. If new safety issues are reported, the
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Company may be required to amend the conditions of use for a product. For example, the Company may be required to provide additional warnings on a product’s label or narrow its approved intended use, either of which could reduce the product’s market acceptance. If serious safety issues arise with its product, sales of the product could be halted by the Company or by regulatory authorities. Safety issues affecting suppliers’ or competitors’ products also may reduce the market acceptance of the Company’s products.
Inability to attract and maintain key personnel may cause the Company’s business to fail.
Success depends on the acquisition of key personnel. The Company will have to compete with other companies both within and outside the healthcare industry to recruit and retain competent employees and consultants. If the Company cannot maintain qualified personnel to meet the needs of its anticipated growth, we could face material adverse effects on the Company’s business and financial condition.
The Company lacks operating history and to date has generated only minimal revenues. If the Company cannot increase its revenue to start generating profits, its investors may lose their entire investment.
To date, the Company has generated only minimal revenues. No profits have been made to date and if the Company fails to make any then it may fail as a business and an investment in its common stock will be worth nothing. The Company has a limited operating history and thus its progress as well as potential future success cannot be reasonably estimated. Success has yet to be proven and financial losses should be expected to continue in the near future and at least until such time that the Company enters commercial production of devices based on the eBalance® Technology, of which there is no assurance. As a new business, the Company faces all the risks of a ‘start-up’ venture including unforeseen costs, expenses, problems, and management limitations and difficulties. Since inception, the Company has accumulated deficit of $11,756,931 and there is no guarantee, that it may ever be able to turn a profit or locate additional opportunities, hire additional management and other personnel.
Debt Owing to Related Parties
As of May 31, 2026, the Company had approximately $1,498,798 in amounts due to related parties and notes payable, consisting of amounts due to related parties of $665,321 and notes and advances payable of $833,477. If the Company is unable to repay these amounts when due, it may be required to settle the debt through the issuance of Common Shares, which would result in dilution to existing shareholders. The Company has previously settled related party debt through the issuance of Common Shares, including the conversion of $1,622,693 in outstanding debt into 15,454,221 Common Shares in December 2023.
The Company needs to acquire additional financing, or its business will fail.
The Company must obtain additional capital, or its business will fail. In order to continue development of its eBalance® Technology, apply for medical licenses, FDA approvals, and to carry out its additional observational and clinical trials, the Company must secure more funds. Currently, the Company has limited resources and has already accumulated a deficit. The Company does not have immediate sources of financing. Financing may be subject to numerous factors including investor sentiment, acceptance of the Company’s technology and so on. The Company may also have to borrow large sums of money that require substantial capital and interest payments.
Currency Risk
The Company reports its financial results in U.S. dollars but incurs a portion of its operating expenses in Canadian dollars. Fluctuations in the exchange rate between the U.S. dollar and the Canadian dollar may affect the Company’s results of operations and the value of its assets and liabilities. The Company does not currently use any hedging instruments to mitigate its exposure to foreign currency fluctuations. A decline in the value of the U.S. dollar relative to the Canadian dollar could increase the Company’s operating costs and have a material adverse effect on its financial condition and results of operations.
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Working Capital Deficiency
The Company has a working capital deficiency. See “Use of Available Funds.” The Company has not generated significant revenue from operations and has funded its activities through debt and equity financing. The Company’s ability to continue operations is dependent on its ability to obtain additional financing and ultimately achieve profitable operations. There is no assurance that the Company will be successful in obtaining such financing or achieving profitability. If the Company is unable to secure adequate financing, it may be required to curtail or cease its operations, and investors may lose their entire investment.
Risks related to the Company’s stock
The Company expects to raise additional capital through the offering of more shares, which will result in dilution to its current shareholders.
Raising additional capital through future offerings of common stock is expected to be necessary for the Company to continue. However, there is no guarantee that the Company will be successful in raising additional capital. Issuance of additional stock will increase the total number of shares issued and outstanding resulting in decrease of the percentage interest held by each of the Company’s shareholders.
The Company may, from time to time, convert some of its debt into shares of the Company’s common stock, which will result in dilution to its shareholders.
To reduce the Company’s liabilities and improve its financial position, the Company may convert its debt into shares of common stock. The issuance of additional stock increases the total number of shares issued and outstanding, resulting in a decrease in the percentage of interest held by each of the Company’s shareholders, thereby further diluting their position.
There is a limited market for the Company’s common stock, meaning that its shareholders may not be able to resell their shares.
The Company’s common stock currently has a limited market, which may restrict shareholders’ ability to resell their stock or use their stock as collateral. Thus, the shareholders may have to sell their shares privately, which may prove exceedingly difficult. Private sales are more difficult and often give lower-than-anticipated prices.
Should a larger public market develop for the Company’s stock, future sales of shares may negatively affect their market price.
Even if a larger market develops, the shares may be sparsely traded and have wide share price fluctuations. Liquidity may be low despite there being a market, making it difficult to get a return on the investment. The price also depends on potential investors’ feelings regarding the results of the Company’s operations, the competition of other companies’ shares, its ability to generate future revenues, and market perception about the future of microcurrent technologies.
Because the Company’s stock is a penny stock, stockholders will be more limited in their ability to sell their stock.
The SEC has adopted rules that regulate broker-dealer practices in connection with transactions in penny stocks. Penny stocks are generally equity securities with a price of less than $5.00, other than securities registered on certain national securities exchanges or quoted on the NASDAQ system, provided that current price and volume information with respect to transactions in such securities is provided by the exchange or quotation system.
Because the Company’s securities constitute “penny stocks” within the meaning of the rules, the rules apply to the Company and to its securities. The rules may further affect the ability of owners of shares to sell the Company’s securities in any market that might develop for them. As long as the quotation price of the Company’s common stock is less than $5.00 per share, the common stock will be subject to Rule 15g-9 under the Exchange Act. The penny stock rules require a broker-dealer, prior to a transaction in a penny stock, to deliver a standardized risk disclosure document prepared by the SEC, that:
·contains a description of the nature and level of risk in the market for penny stocks in both public offerings and secondary trading;
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·contains a description of the broker’s or dealer’s duties to the customer and of the rights and remedies available to the customer with respect to a violation to such duties or other requirements of securities laws;
·contains a brief, clear, narrative description of a dealer market, including bid and ask prices for penny stocks and the significance of the spread between the bid and ask price;
·contains a toll-free telephone number for inquiries on disciplinary actions;
·defines significant terms in the disclosure document or in the conduct of trading in penny stocks; and
·contains such other information and is in such form, including language, type, size, and format, as the SEC shall require by rule or regulation.
The broker-dealer also must provide, prior to effecting any transaction in a penny stock, the customer with: (a) bid and offer quotations for the penny stock; (b) the compensation of the broker-dealer and its salesperson in the transaction; (c) the number of shares to which such bid and ask prices apply, or other comparable information relating to the depth and liquidity of the market for such stock; and (d) a monthly account statements showing the market value of each penny stock held in the customer’s account. In addition, the penny stock rules require that, prior to a transaction in a penny stock not otherwise exempt from those rules, the broker-dealer must make a special written determination that the penny stock is a suitable investment for the purchaser and receive the purchaser’s written acknowledgment of the receipt of a risk disclosure statement, a written agreement to transactions involving penny stocks, and a signed and dated copy of a written suitability statement. These disclosure requirements may have the effect of reducing the trading activity in the secondary market for the Company’s stock.
The Company has not paid nor anticipates paying cash dividends on its common stock.
The Company has not declared any dividends on its common stock during the past two fiscal years or at any time in its history. The Nevada Revised Statutes (the “NRS”), provide certain limitations on the Company’s ability to declare dividends. Section 78.288 of Chapter 78 of the NRS prohibits the Company from declaring dividends where, after giving effect to the distribution of the dividend:
(a)the Company would not be able to pay its debts as they become due in the usual course of business; or
(b)except as may be allowed by the Company’s Articles of Incorporation, its total assets would be less than the sum of its total liabilities plus the amount that would be needed, if the Company was to be dissolved at the time of the distribution, to satisfy the preferential rights upon dissolution of stockholders who may have preferential rights and whose preferential rights are superior to those receiving the distribution.
The Company does not expect to declare any dividends in the foreseeable future as it expects to spend any funds legally available for the payment of dividends on the development of its business.
No assurance that forward-looking assessments will be realized.
The Company’s ability to accomplish its objectives and whether or not it is financially successful is dependent upon numerous factors, each of which could have a material effect on the results obtained. Some of these factors are in the discretion and control of management and others are beyond management’s control. The assumptions and hypotheses used in preparing any forward-looking assessments contained herein are considered reasonable by management. There can be no assurance, however, that any projections or assessments contained herein or otherwise made by management will be realized or achieved at any level.
FOR ALL OF THE AFORESAID REASONS AND OTHERS SET-FORTH AND NOT SET-FORTH HEREIN, AN INVESTMENT IN THE COMPANY’S SECURITIES INVOLVES A CERTAIN DEGREE OF RISK. ANY PERSON CONSIDERING TO INVEST IN THE COMPANY’S SECURITIES SHOULD BE AWARE OF THESE AND OTHER FACTORS SET-FORTH IN THIS REPORT AND IN THE OTHER REPORTS AND DOCUMENTS THAT THE COMPANY FILES FROM TIME TO TIME WITH THE SEC AND SHOULD CONSULT WITH HIS/HER LEGAL, TAX, AND FINANCIAL ADVISORS PRIOR TO MAKING AN INVESTMENT IN THE COMPANY’S SECURITIES. AN INVESTMENT IN THE COMPANY’S SECURITIES SHOULD ONLY BE ACQUIRED BY PERSONS WHO CAN AFFORD TO LOSE THEIR TOTAL INVESTMENT.
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ITEM 1B. UNRESOLVED STAFF COMMENTS.
None.
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