Catheter Precision (VTAK) risk factors, FY2024 10-K

Risks Related to Our Financial Position and Need for Additional Capital

1. 01We will be required to raise additional funds to finance our operations and continue as a going concern; We may not be able to do so when necessary, and/or the terms of any financings may not be advantageous to us
2. 02Our business has a history of losses and will incur additional losses, and we may never achieve profitability

Risks Related to Our Internal Controls

1. 03We have identified material weaknesses in our internal control over financial reporting. These material weaknesses could adversely affect our ability to report our results of operations and financial condition accurately and in a timely manner
2. 04Compliance with Section 404 of the Sarbanes-Oxley Act could have a material adverse impact on our business

Risks Related to Our Business and Products

1. 05We will not be able to reach profitability unless we are able to achieve our product expansion and growth goals
2. 06Collaborate with clinical thought leaders to establish clinical techniques, evolve our product features and demonstrate enhanced capabilities to broaden the appeal of VIVO and LockeT
3. 07Enhance the design, user utility and clinical capability of VIVO and LockeT through further product development and collaboration with clinical users
4. 08Opportunistically identify acquisitions to enhance our enterprise scale, sales synergy and fixed cost coverage
5. 09Our research and development and commercialization efforts may depend on entering into agreements with corporate collaborators
6. 10Economic uncertainty or downturns, and related tariffs, particularly as they impact particular industries, could adversely affect our business and results of operations
7. 11Artificial intelligence-based platforms may present new risks and challenges to our business
8. 12We have previously entered into joint marketing agreements with respect to our products and may enter into additional joint marketing agreements that will reduce our revenues from product sales
9. 13Royalty agreements with respect to LockeT, our surgical vessel closing pressure device, will reduce any future profits from this product
10. 14If we experience significant disruptions in our information technology systems, our business may be adversely affected
11. 15The rate of technological innovation of our products might not keep pace with the rest of the market
12. 16Litigation and other legal proceedings may adversely affect our business
13. 17If we make acquisitions or divestitures, we could encounter difficulties that harm our business
14. 18Failure to attract and retain sufficient qualified personnel could also impede our growth
15. 19Our revenues may depend on our customers’ receipt of adequate reimbursement from private insurers and government sponsored healthcare programs
16. 20We may be unable to compete successfully with companies in our highly competitive industry, many of whom have substantially greater resources than we do
17. 21If hospitals, physicians and patients do not accept our current and future products or if the market for indications for which any product candidate is approved is smaller than expected, we may be unable to generate significant revenue, if any
18. 22The recent coronavirus, or COVID-19, outbreak adversely affected our financial condition and results of operations, and we cannot provide any certainty as to whether there will be future impacts from COVID-19 or another pandemic
19. 23A variety of risks associated with marketing our products internationally could materially adversely affect our business
20. 24These and other risks associated with international operations may materially adversely affect our ability to attain or maintain profitable operations, which would have a material adverse effect on our business, financial condition, and results of operations
21. 25We may use independent clinical investigators and other third-party service providers to conduct and/or oversee the clinical trials of our product candidates
22. 26We may be adversely affected by product liability claims, unfavorable court decisions or legal settlements
23. 27Our ability to use our net operating loss carryforwards may be limited

Risks Related to Governmental Regulation and our Industry

1. 28Our medical device operations are subject to pervasive and continuing FDA regulatory requirements
2. 29obtaining premarket notification 510(k) clearance for devices prior to marketing
3. 30Product clearances and approvals can often be denied or significantly delayed
4. 31require a product recall
5. 32Our products may be subject to additional recalls, revocations or suspensions after receiving FDA or foreign approval or clearance, which could divert managerial and financial resources, harm our reputation, and adversely affect our business
6. 33If we or our suppliers fail to comply with the FDA’s Quality System Regulation, or QSR, or any applicable state equivalent, our operations could be interrupted, and our potential product sales and operating results could suffer
7. 34If any of our products cause or contribute to a death or a serious injury, or malfunction in certain ways, we will be required to report under applicable medical device reporting regulations, which can result in voluntary corrective actions or agency enforcement actions
8. 35There have been and continue to be proposals by the federal government, state governments, regulators and third-party payors to control or manage the increasing costs of healthcare and, more generally, to reform the U.S. healthcare system
9. 36Healthcare cost containment pressures and legislative or administrative reforms resulting in restrictive coverage and reimbursement practices of third-party payors could decrease the demand for our products and the number of procedures performed using our devices, which could have an adverse effect on our business
10. 37We are regulated by federal Anti-Kickback Statutes
11. 38We are regulated by the federal Stark Law
12. 39We must comply with Health Information Privacy and Security Standards
13. 40If a breach of our measures protecting personal data covered by HIPAA, as amended by the HITECH Act, occurs, we may incur significant liabilities
14. 41A cyber security incident could cause a violation of HIPAA and/or state consumer privacy laws, breach of customer and patient privacy, or other negative impacts
15. 42We must comply with environmental and Occupational Safety and Health Administration Regulations
16. 43We must comply with a range of other Federal and State Healthcare Laws
17. 44Governmental export or import controls could limit our ability to compete in foreign markets and subject us to liability if we violate them

Risks Related to our Intellectual Property

1. 45We may not be able to protect our intellectual property and proprietary rights throughout the world
2. 46Third parties may attempt to commercialize competitive products or services in foreign countries where we do not have any patents or patent applications where legal recourse may be limited. This may have a significant commercial impact on our foreign business operations
3. 47Third parties may assert that we are infringing their intellectual property rights, and any defense of such assertions may be unsuccessful and expensive, even if we are successful
4. 48Expensive intellectual property litigation is frequent in the medical device industry and may cause to incur substantial expenses to defend

Risks Related to Ownership of Our Common Stock

1. 49other events or factors, many of which are beyond our control
2. 50We are a smaller reporting company, and we cannot be certain if the reduced reporting requirements applicable to smaller reporting companies will make our common stock less attractive to investors
3. 51Future sales and issuances of a substantial number of shares of our common stock or rights to purchase common stock by our stockholders in the public market could result in additional dilution of the percentage ownership of our stockholders and cause our stock price to fall
4. 52We are subject to the continued listing requirements of the NYSE American. If we are unable to comply with such requirements, 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
5. 53a decreased ability to issue additional securities or obtain additional financing in the future
6. 54We have not paid dividends in the past and have no immediate plans to pay dividends