enVVeno Medical (NVNO) risk factors, FY2025 10-K

Risks Related to Our Business and Strategy

1. 01We have incurred losses since our inception, expect to incur losses in the future and may never achieve or sustain profitability33% rewritten
2. 02If we are unable to successfully raise additional capital, our future clinical trials and product development could be limited and our long-term viability may be threatened
3. 03We may not be able to acquire additional funds on acceptable terms, or at all. If we are unable to raise adequate funds, we may have to liquidate some or all of our assets or delay, reduce the scope of or eliminate some or all of our development programs
4. 04We may never be able to generate sufficient revenue from the commercialization of our product candidates to achieve and maintain profitability
5. 05We only utilize a few suppliers for porcine tissue for our product candidates and the loss of a supplier could have an adverse impact on our business
6. 06We depend upon third-party suppliers for certain components of our product candidates, making us vulnerable to supply problems and price fluctuations, which could harm our business
7. 07If we successfully develop product candidates, which at this time will likely take several years at a minimum, we will have to demonstrate the efficacy and financial viability of our products to doctors, hospitals, insurance companies, and other stakeholders
8. 08We may be unable to convince hospital facilities to approve the use of our product candidates
9. 09We face significant competition and our business prospects will depend on our ability to develop and commercialize our current product candidates and may also depend on our ability to develop additional product candidates
10. 10If we are unsuccessful in developing and commercializing additional devices in other areas, our ability to realize our revenue may be impaired
11. 11If we are unable to produce an adequate supply of our product candidates for use in our current and planned clinical trials or for commercialization because of our limited manufacturing resources or our facility is damaged or becomes inoperable, our regulatory, development and commercialization efforts may be delayed
12. 12Product liability lawsuits against us could cause us to incur substantial liabilities, limit sales of our existing product candidates and limit commercialization of any products that we may develop
13. 13The loss of our executive officers or our inability to attract and retain qualified personnel may adversely affect our business, financial conditions and results of operations
14. 14Our ability to use our net operating loss carryforwards and certain other tax attributes may be limited34% rewritten

Risks Related to Regulatory Approval and Other Governmental Regulations

1. 15Our business and product candidates are subject to extensive governmental regulation and oversight, and our failure to comply with applicable regulatory requirements could harm our business
2. 16The Company received a not-approvable letter from the FDANew
3. 17Our product candidates will be subject to extensive governmental regulation in foreign jurisdictions, such as the EEA, and our failure to comply with applicable requirements could cause our business, results of operations and financial condition to suffer
4. 18The FDA regulatory approval, clearance and license process is complex, time-consuming and unpredictable24% rewritten
5. 19Even if our product candidates are approved by regulatory authorities, if we fail to comply with ongoing regulatory requirements, or if we experience unanticipated problems with our product candidates, our product candidates could be subject to restrictions or withdrawal from the market
6. 20We are required to report certain malfunctions, deaths and serious injuries associated with our products once approved by regulatory bodies, which can result in voluntary corrective actions or agency enforcement actions
7. 21Legislative or regulatory reforms in the United States or the EU may make it more difficult and costly for us to obtain regulatory clearances or approvals for product candidates or to manufacture, market or distribute product candidates after clearance or approval is obtained
8. 22Any of these changes could require substantial time and cost and could harm our business and our financial results
9. 23We are subject to federal, state and foreign healthcare laws and regulations, and a finding of failure to comply with such laws and regulations could have a material and adverse effect on our business
10. 24Regulatory healthcare reform measures and other legislative changes may have a material and adverse effect on business, results of operations and financial condition
11. 25Our relationships with physician consultants, owners and investors could be subject to additional scrutiny from regulatory enforcement authorities and could subject us to possible administrative, civil or criminal sanctions

Risks Related to Our Intellectual Property

1. 26If we are unable to adequately protect our proprietary technology or obtain and maintain issued patents that are sufficient to protect our product candidates, others could compete against us more directly, which could harm our business, financial condition and results of operations
2. 27Obtaining and maintaining our patent protection depends on compliance with various procedures, document submission requirements, fee payments and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements
3. 28Our success will depend in part on our ability to operate without infringing the intellectual property and proprietary rights of third parties. Our business, product candidates and methods could infringe the patents or other intellectual property rights of third parties

Risks Related to Ownership of Our Securities

1. 29The trading price of our securities has been and is likely to continue to be volatile and could be subject to wide fluctuations in response to a variety of factors21% rewritten
2. 30We will need to raise additional capital to meet our business requirements in the future, and such capital raising may be costly or difficult to obtain and can be expected to dilute current stockholders’ ownership interests
3. 31Future sales or issuances of substantial amounts of our common stock could result in significant dilution
4. 32Our failure to meet the continued listing requirements of Nasdaq could result in a de-listing of our Common Stock
5. 33Provisions of our charter documents or Delaware law could delay or prevent an acquisition of us, even if the acquisition would be beneficial to our stockholders, which could make it more difficult for you to change management
6. 34We do not anticipate paying any cash dividends on our common stock in the foreseeable future and, as such, capital appreciation, if any, of our common stock will be your sole source of gain for the foreseeable future