PAVmed (PAVM) risk factors, FY2024 10-K

Other

1. 01We have concluded there is substantial doubt of our ability to continue as a going concern and our independent registered public accounting firm’s report on our financial statements contains an explanatory paragraph describing our ability to continue as a going concern
2. 02We have faced significant challenges raising capital under the current market conditions, and therefore are highly dependent on the ability of each of our subsidiaries to raise capital to fund its own and our operations
3. 03There can be no assurance that our common stock will continue to trade on the Nasdaq Capital Market or another national securities exchange
4. 04The Company currently is (and from time to time in the recent past, the Company has been) out of compliance with the standards and requirements for continued listing on Nasdaq
5. 05If we were delisted, that could have a material adverse effect on your investment in the Company, including without limitation by substantially reducing the liquidity of our common stock, and by further limiting our access to capital markets for fundraising
6. 06Servicing our indebtedness may require a significant amount of cash, and the restrictive covenants contained in the documents that govern our indebtedness and preferred stock could adversely affect our business plan, liquidity, financial condition, and results of operations
7. 07The terms of our Series C Preferred Stock also include covenants substantially similar to those in the documentation that governs our outstanding indebtedness, and accordingly, those covenants (and our failure to be in compliance with the same) could have the same important consequences on our business
8. 08The accounting method for convertible debt securities that may be settled in cash, such as the September 2022 Senior Convertible Note, could have a material effect on our reported financial results
9. 09We will need substantial additional funding and may be unable to raise capital when needed, which could force us to delay, reduce, eliminate or abandon growth initiatives or product development programs
10. 10The markets in which we operate are highly competitive, and we may not be able to effectively compete against other providers of medical devices, particularly those with greater resources
11. 11We have finite resources, which may restrict our success in commercializing our current products and other products we may develop, and we may be unsuccessful in entering into or maintaining third-party arrangements to support our internal efforts
12. 12If we are unable to deploy and maintain effective sales, marketing and medical affairs capabilities, we will have difficulty achieving market awareness and selling our tests and other products
13. 13Our products may never achieve market acceptance
14. 14Recommendations, guidelines and quality metrics issued by various organizations may significantly affect payors’ willingness to cover, and healthcare providers’ willingness to prescribe, our products
15. 15We or our third-party manufacturers may not have the manufacturing and processing capacity to meet the production requirements of clinical testing or consumer demand in a timely manner
16. 16The manufacturing processes for our products have not yet been tested at commercial levels, and it may not be possible to manufacture or process these materials in a cost-effective manner
17. 17We may make investments in products we have not yet developed, and those investments may not be realized
18. 18We may not obtain the expected benefits of the incubator financing structure and may incur additional costs
19. 19Our products and services may become subject to unfavorable pricing regulations, third-party reimbursement practices or healthcare reform initiatives, thereby harming our business
20. 20Our products and services may cause serious adverse side effects or even death or have other properties that could delay or prevent their regulatory approval, limit the commercial desirability of an approved label or result in significant negative consequences following any marketing approval
21. 21Product liability lawsuits against us could cause us to incur substantial liabilities and to limit commercialization of any products that we may develop
22. 22We may not be able to protect or enforce our intellectual property rights, which could impair our competitive position
23. 23We may be subject to intellectual property infringement claims by third parties which could be costly to defend, divert management’s attention and resources, and may result in liability
24. 24Competitors may violate our intellectual property rights, and we may bring litigation to protect and enforce our intellectual property rights, which may result in substantial expense and may divert our attention from implementing our business strategy
25. 25Our business may suffer if we are unable to manage our growth
26. 26Our ability to be successful will be totally dependent upon the efforts of our key personnel
27. 27Our officers and directors have fiduciary obligations to other companies and, accordingly, may have conflicts of interest in determining to which entity a particular business opportunity should be presented
28. 28Our business, financial condition and results of operations could be adversely affected by the political and economic conditions of the countries in which we conduct business
29. 29Failure in our information technology or storage systems could significantly disrupt our operations and our research and development efforts, which could adversely impact our revenues, as well as our research, development and commercialization efforts
30. 30We may become the subject of various claims, threats of litigation, litigation or investigations which could have a material adverse effect on our business, financial condition, results of operations or price of our common stock
31. 31If private or governmental third-party payors do not maintain reimbursement for our products at adequate reimbursement rates, we may be unable to successfully commercialize our products which would limit or slow our revenue generation and likely have a material adverse effect on our business
32. 32The results of the Company’s clinical trials may not support our product candidate claims or may result in the discovery of adverse side effects
33. 33Even if we receive regulatory approval for any product we may develop, we will be subject to ongoing regulatory obligations and continued regulatory review, which may result in significant additional expense and subject us to penalties if we fail to comply with applicable regulatory requirements
34. 34Healthcare reform measures, including those targeting Medicare or Medicaid, could hinder or prevent our products’ commercial success
35. 35If we fail to comply with healthcare regulations, we could face substantial penalties and our business, operations and financial condition could be adversely affected
36. 36The Company’s medical products may in the future be subject to product recalls that could harm its reputation, business and financial results
37. 37If the Company’s medical products cause or contribute to a death or a serious injury, or malfunction in certain ways, we will be subject to medical device reporting regulations, which can result in voluntary corrective actions or agency enforcement actions
38. 38We may issue shares of our common and /or preferred stock in the future which could reduce the equity interest of our stockholders and might cause a change in control of our ownership
39. 39The holder of our convertible debt and the holder of our Series C Preferred Stock have certain rights with respect to the shares in Lucid Diagnostics that we own, which may have a material impact on the return on any investment in shares of our common stock
40. 40Our management and their affiliates control a substantial interest in us and thus may influence certain actions requiring a stockholder vote
41. 41A robust public market for our common stock may not be sustained, which could affect your ability to sell our common stock or depress the market price of our common stock
42. 42Our stock price may be volatile, and purchasers of our securities could incur substantial losses
43. 43Our outstanding warrants and other convertible securities may have an adverse effect on the market price of our common stock and the value of your investment in us
44. 44(iv) 25,000 shares of Series C Preferred Stock, convertible into 23,408,240 of our common stock (assuming the shares of Series C Preferred Stock were converted in full on such date at the fixed conversion price of $1.068 per share)
45. 45We do not intend to pay any cash dividends on our common stock at this time
46. 46We have made distributions of shares of Lucid common stock to our shareholders in the past, but there is no assurance we will do so in the future
47. 47We are subject to evolving corporate governance and public disclosure expectations and regulations that impact compliance costs and risks of noncompliance
48. 48We incur significant costs as a result of our and Lucid Diagnostics operating as a public company, and our management will be required to devote substantial time to compliance initiatives
49. 49If we experience material weaknesses in our internal control over financial reporting in the future, our business may be harmed
50. 50If securities or industry analysts do not publish research, or publish inaccurate or unfavorable research, about our business, our stock price and trading volume could decline
51. 51Provisions in our corporate charter documents and under Delaware law could make an acquisition of us more difficult and may prevent attempts by our stockholders to replace or remove our current management