Loading...
Loading...
Chat is set up on each filing report page.
Ask about this filing, its industry, or sector trends.
AI responses are generated from filing and peer context and may contain errors.
ITEM 1A. RISK FACTORS.
There is a high degree of risk associated with buying the Companys 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 Companys 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 Companys 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 Companys 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 Companys 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 Companys 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 Companys 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.
9
Inability to protect and enforce the Companys 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 Companys 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
10
any of the Companys intellectual property rights are invalid could allow the Companys 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 Companys 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 Companys 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 Companys 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 Companys 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 Companys products to become obsolete, causing its revenues and operating results to suffer.
New products and technological advances by the Companys competitors may negatively affect its results of operations.
The Companys 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
10
Companys products. The Company cannot predict with certainty the timing or impact of the introduction of competitors products.
Significant safety concerns could arise for the Companys 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
11
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 products label or narrow its approved intended use, either of which could reduce the products 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 Companys products.
Inability to attract and maintain key personnel may cause the Companys 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 Companys 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 $10,295,263861,556 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.
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 Companys technology and so on. The Company may also have to borrow large sums of money that require substantial capital and interest payments.
Risks related to the Companys 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 Companys shareholders.
The Company expectsmay, from time to time, convert some of the existingits debt into shares of itthe Companys common stock, which will result in dilution to its current shareholders.
In December 2023, the Company issued 231,813,31015,454,221 shares of its common stock on conversion of a total of $1,622,693 in then current liabilities, which. The conversion resulted in a decrease to itin the Companys working capital deficit. In ordTo further to reduce the
11
Companys liabilities and improve its financial position further, the Company may continue to converting its remaining debt into shares of common stock. IThe issuance of additional stock increases the total number of shares issued and outstanding, resulting in decrease of the percentage interest held by each of the Companys shareholders, further diluting their position.
Due to the current financial situation, and to improve the likelihood of successful financing in a decrease in the future, the Company has decided to consolidate issued and outstanding shares of its common stock.
In order to improve the financial position, the Company has elected to consolidate its issued and outstanding sharespercentage of common stock. The effect of a share consolidation on the per share trading price of the Companys common stock cannot be predicted with any certainty, and the history of share consolidations for other companies is varied, particularly since some investors may view a share consolidation negatively. It is possible that the per share trading price of the Companys common stock after the share consolidation is finalized would not increase in the same proportion as the reduction in the number ointerest held by each of the Companys outstanding sshares of common stock following the share consolidation or at all, and a share consolidation may not result in a per share trading price that would attract investors who do not trade in lower priced stocks. The Company cannot assure its shareholders that, if a share consolidation is implemented, its common stock will be more attractive to investors. Once the Company implements a share consolidation, the per share trading price of its common stock may decrease due to factors unrelated to the share consolidation, including its future performance. Once the share consolidation is consummated, should the per share trading price of the Companys common stock decline, the percentages decline as an absolute number and as a percentage of the Companys overall market capitalization may be greater than would occur in the absence of a share consolidation.
A share consolidation may decrease the liquidity of the Companys common stock and result in highholders, thereby further transaction costs. The liquidity of the Companys common stock may be negatively impacted by a share consolidation, given the reduced number of shares that would be outstanddiluting after the share consolidation, particularly if the per share trading price does not increase as a result of the share consolidatitheir position. In addition, once the share consolidation is finalized, it will increase the number of the Companys stockholders who own odd lots of fewer than
100 shares of common stock. Brokerage commission and other costs of transactions in odd lots are generally higher than the costs of transactions of more than 100 shares of common stock.
2
There is a limited market for the Companys common stock, meaning that its shareholders may not be able to resell their shares.
The Companys 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 Companys 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 Companys operations, the competition of other companies shares, its ability to generate future revenues, and market perception about the future of microcurrent technologies.
Because the Companys 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 Companys 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 Companys securities in any market that might develop for them. As long as the quotation price of the Companys 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:
12
contains a description of the nature and level of risk in the market for penny stocks in both public offerings and secondary trading;
contains a description of the brokers or dealers 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 customers 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 purchasers 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 Companys 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 Companys 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:
13
(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 Companys 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 Companys 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 managements 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 COMPANYS SECURITIES INVOLVES A CERTAIN DEGREE OF RISK. ANY PERSON CONSIDERING TO INVEST IN THE COMPANYS 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 COMPANYS SECURITIES. AN INVESTMENT IN THE COMPANYS SECURITIES SHOULD ONLY BE ACQUIRED BY PERSONS WHO CAN AFFORD TO LOSE THEIR TOTAL INVESTMENT.
13