Sanuwave Health (SNWV) risk factors, FY2025 10-K

Risks Related to our Business

1. 01There can be no assurance as to when the material weaknesses will be remediated. These remediation measures will be time consuming, will result in us incurring significant costs, and will place significant demands on our financial and operational resourcesNew
2. 02Our ability to utilize our net operating loss carryforwards and certain other tax attributes may be limitedNew
3. 03The Company has historically experienced recurring net losses, accumulated deficits, negative working capital, and significant debt maturities, which raised substantial doubt about its ability to continue as a going concernNew
4. 04If 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 business72% rewritten
5. 05The 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 eliminated64% rewritten
6. 06Changes in reimbursement affecting the wound care market could adversely affect our customers and indirectly reduce demand for our productsNew
7. 07The loss of our key management would likely hinder our ability to execute our business plan
8. 08We face an inherent risk of liability if the use or misuse of our products results in personal injury or death
9. 09We are dependent on information technology and our systems and infrastructure face certain risks, including from cybersecurity breaches and data leakage
10. 10If we are unable to expand, manage and maintain our direct sales and marketing organizations, we may not be able to generate anticipated revenue
11. 11If we fail to properly manage our growth effectively, our business could suffer
12. 12Future 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
13. 13We 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
14. 14Provisions in our Articles of Incorporation, Bylaws and Nevada law might decrease the chances of an acquisition

Regulatory Risks

1. 15We are subject to extensive governmental regulation, including the FDA
2. 16Regulatory approval of our products may be withdrawn at any time
3. 17If 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. 18Failure to obtain regulatory approval in foreign jurisdictions will prevent us from marketing our products abroad
5. 19Uncertainty surrounding and future changes to healthcare law in the United States may have a material adverse effect on us
6. 20If 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 operations39% rewritten
7. 21individuals and companies from knowingly submitting false claims for payments to, or improperly retaining overpayments from, the governmentNew
8. 22Failure to comply with the HIPAA and state-specific privacy laws, as such rules become applicable to our business, may increase our operational costs48% rewritten
9. 23We 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. 24Product 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. 25The use of hazardous materials in our operations may subject us to environmental claims or liability

Risks Related to Intellectual Property

1. 26The 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 business23% rewritten
2. 27Patent 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
3. 28Our patents may not be valid or enforceable and may be challenged by third parties
4. 29Issued patents and patent licenses may not provide us with any competitive advantage or provide meaningful protection against competitors
5. 30In 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
6. 31The ability to market the products we develop is subject to the intellectual property rights of third parties24% rewritten

Risks Related to our Common Stock

1. 32Our stock price is volatile
2. 33We 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