Sanuwave Health (SNWV) risk factors, FY2024 10-K

Risks Related to our Business

1. 01If we are unable to successfully raise additional capital, our viability may be threatened; however, if we do raise additional capital, your percentage ownership as a stockholder could decrease and constraints could be placed on the operations of our business
2. 02to procure such required financing could have a material adverse effect on our business, financial condition, and results of operations, or threaten our ability to continue as a going concern
3. 03The medical device/therapeutic product industries are highly competitive and subject to rapid technological change. If our competitors are better able to develop and market products that are safer and more effective than any products we may develop, our commercial opportunities will be reduced or eliminated
4. 04The loss of our key management would likely hinder our ability to execute our business plan
5. 05We face an inherent risk of liability if the use or misuse of our products results in personal injury or death
6. 06We are dependent on information technology and our systems and infrastructure face certain risks, including from cybersecurity breaches and data leakage
7. 07If we are unable to expand, manage and maintain our direct sales and marketing organizations, we may not be able to generate anticipated revenue
8. 08If we fail to properly manage our growth effectively, our business could suffer
9. 09Future growth will continue to impose significant added responsibilities on management, including the need to identify, recruit, train and integrate additional employees. In addition, rapid and significant growth will place a strain on our administrative and operational infrastructure
10. 10We generate a portion of our revenue internationally and are subject to various risks relating to our international activities, which could adversely affect our operating results
11. 11Provisions in our Articles of Incorporation, Bylaws and Nevada law might decrease the chances of an acquisition

Regulatory Risks

1. 12We are subject to extensive governmental regulation, including the FDA
2. 13Regulatory approval of our products may be withdrawn at any time
3. 14If we fail to obtain an adequate level of reimbursement for our approved products by third party payors, there may be no commercially viable markets for our approved products, or the markets may be much smaller than expected
4. 15Failure to obtain regulatory approval in foreign jurisdictions will prevent us from marketing our products abroad
5. 16Uncertainty surrounding and future changes to healthcare law in the United States may have a material adverse effect on us
6. 17If we fail to comply with the United States Federal Anti-Kickback Statute, False Claims Act, and similar state laws, we could be subject to criminal and civil penalties and exclusion from the Medicare and Medicaid programs, which would have a material adverse effect on our business and results of operations
7. 18Failure to comply with the HIPAA and state-specific privacy laws, as such rules become applicable to our business, may increase our operational costs
8. 19noncompliance with such regulations could have a material adverse effect on our business, results of operations and financial condition
9. 20We face periodic reviews and billing audits from governmental and private payors, and these audits could have adverse results that may negatively impact our business
10. 21Product quality or performance issues may be discovered through ongoing regulation by the FDA and by comparable international agencies, as well as through our internal standard quality process
11. 22The use of hazardous materials in our operations may subject us to environmental claims or liability

Risks Related to Intellectual Property

1. 23The protection of our intellectual property is critical to our success, and any failure on our part to adequately protect those rights could materially adversely affect our business
2. 24connection with our collaborations, our ability to protect our proprietary information or obtain patent protection in the future may be impaired, which could have a material adverse effect on our business
3. 25Patent applications owned by us or licensed to us may not result in issued patents, and our competitors may commercialize the discoveries we attempt to patent
4. 26Our patents may not be valid or enforceable and may be challenged by third parties
5. 27Issued patents and patent licenses may not provide us with any competitive advantage or provide meaningful protection against competitors
6. 28In addition, issued patents may not provide commercially meaningful protection against competitors. Other parties may seek and/or be able to duplicate, design around or independently develop products having effects similar or identical to our patented products that are not within the scope of our patents
7. 29The ability to market the products we develop is subject to the intellectual property rights of third parties
8. 30materially harm our business. We cannot guarantee that our products or technologies will not conflict with the intellectual property rights of others

Risks Related to our Common Stock

1. 31Our stock price is volatile
2. 32We have not paid dividends in the past and do not expect to pay dividends in the future. Any return on investment may be limited to the value of our common stock
3. 33The rights of the holders of common stock may be impaired by the potential issuance of preferred stock
4. 34We have not sought an advisory stockholder vote to approve the compensation of our named executive officers