USBC (USBC) risk factors, FY2024 10-K

Risks Related to Our Business and Industry

1. 01We need additional financing to support our technology development and ongoing operations, pay our debts and maintain ownership of our intellectual property
2. 02We need to continue as a going concern if our business is to succeed
3. 03As of September 30, 2024, we owed approximately $4,724,000 and if we do not satisfy these obligations, the lenders may have the right to demand payment in full or exercise other remedies
4. 04We have a history of operating losses and there can be no assurance that we can achieve or maintain profitability
5. 05We may not be able to generate sufficient revenue from the commercialization of our technology and related products to achieve or sustain profitability
6. 06We are subject to extensive regulation by the FDA, which could require us to take significant time and could cause us to incur significant costs
7. 07The clinical trial process is lengthy and expensive with uncertain outcomes. Results of earlier studies may not be predictive of future clinical trial results, or the safety or efficacy profile for such products
8. 08FDA concludes that the results from our trial and/or trial design are inadequate to demonstrate safety and effectiveness of the product
9. 09Any of these occurrences may significantly harm our business, financial condition, and prospects. In addition, many of the factors that cause, or lead to, a delay in the commencement or completion of clinical trials may also ultimately lead to the denial of regulatory approval of our product candidates
10. 10The safety and efficacy of our products is not yet supported by long-term clinical data, which could limit sales, and our products might therefore prove to be less safe or effective than initially thought
11. 11Medical devices may be marketed only for the indications for which they are approved or cleared. Further, clearances can be revoked if safety or effectiveness problems develop once the device is on the market
12. 12The occurrence of any of these events would have a material adverse effect on our business, financial condition and results of operations and could result in stockholders losing their entire investment
13. 13analogous state and foreign laws and regulations, such as state anti-kickback and false claims laws, may apply to sales or marketing arrangements and claims involving healthcare items or services reimbursed by non-governmental third-party payors, including private insurers
14. 14A variety of risks associated with marketing our product candidates internationally could materially adversely affect our business
15. 15We may face difficulties with respect to coverage and reimbursement by various payors
16. 16The discovery of serious safety issues with our products, or a recall of our products either voluntarily or at the direction of FDA or another governmental authority, could have a negative impact on us
17. 17We may face difficulties from changes to current regulations and future legislation, both in the U.S. as well as in other foreign jurisdictions where we may be operating
18. 18Our fields of therapeutic interest is highly competitive and subject to significant and rapid technological change. Accordingly, our success may depend, in part, on our ability to respond quickly to such change through the development and introduction of new products
19. 19We currently rely upon external resources for many engineering and product development services. If we are unable to secure engineering or product development partners or establish satisfactory engineering and product development capabilities, we may not be able to successfully commercialize our technology
20. 20We are in the early stages of commercialization and our technology and related products may never achieve significant commercial market acceptance
21. 21We are dependent on key personnel
22. 22We rely on the timely supply of components and parts and could suffer if suppliers fail to meet their delivery obligations, raise prices or cease to supply us with components or parts
23. 23The failure of our suppliers to deliver components or products in a timely fashion could have disruptive effects on our ability to produce our products in a timely manner, or we may be required to find new suppliers at an increased cost
24. 24We have limited insurance which may not cover claims by third parties against us or our officers and directors
25. 25Our inability to effectively protect our intellectual property would adversely affect our ability to compete effectively, our revenue, our financial condition and our results of operations
26. 26If we are prevented from selling our products, or if we are required to develop new technologies or pay significant monetary damages or are required to make substantial royalty payments, our business and results of operations would be harmed
27. 27Claims by others that our products infringe their patents or other intellectual property rights could prevent us from manufacturing and selling some of our products or require us to pay royalties or incur substantial costs from litigation or development of non-infringing technology
28. 28If we are unable to secure a sales and marketing partner or establish satisfactory sales and marketing capabilities at our company, we may not be able to successfully commercialize our technology
29. 29We may engage in acquisitions, mergers, strategic alliances, joint ventures and divestures that could result in final results that are different than expected
30. 30We may make strategic acquisitions in the future, and if the acquired companies do not perform as expected, this could adversely affect our operating results, financial condition and existing business
31. 31the availability of management resources to oversee the integration and operation of the acquired businesses
32. 32Government regulatory approval may be necessary before some of our products can be sold and there is no assurance such approval will be granted
33. 33We or our manufacturers may be unable to obtain or maintain international regulatory clearances or approvals for our current or future products, or our distributors may be unable to obtain necessary qualifications, which could harm our business thus limited sales to the U.S
34. 34We are subject to corporate governance and internal control requirements, and our costs related to compliance with, or our failure to comply with existing and future requirements could adversely affect our business

Risks Related to Ownership of Our Common Stock

1. 35If we are unable to comply with the continued listing requirements of the NYSE American, then our common stock would be delisted from the NYSE American, which would limit investors’ ability to effect transactions in our common stock and subject us to additional trading restrictions
2. 36There is no assurance that we will be able to maintain compliance with the NYSE American continued listing rules and/or continue its listing on the NYSE American in the future
3. 37a limited amount of news and analyst coverage; and
4. 38The price of our common stock is volatile, which may cause investment losses for our stockholders
5. 39Additions or departures of key personnel
6. 40The sale of a significant number of our shares of common stock could depress the price of our common stock
7. 41Future capital raises or other issuances of equity or debt securities may dilute our existing stockholders’ ownership and/or have other adverse effects on our operations
8. 42In the future, we may also attempt to increase our capital resources by offering debt securities. These debt securities would have rights senior to those of our common stock and the terms of the debt securities issued could impose significant restrictions on our operations, including liens on our assets
9. 43The exercise prices of certain warrants, and the conversion prices of our outstanding convertible notes payable and our preferred stock may require further adjustment
10. 44If our company were to dissolve or wind-down operations, holders of our common stock would not receive a liquidation distribution
11. 45Provisions of the warrants could discourage an acquisition of us by a third party
12. 46We do not anticipate paying any cash dividends on our capital stock in the foreseeable future