This Annual Report on Form 10-K contains forward-looking statements about us and our industry that involve substantial risks and uncertainties. All statements other than statements of historical facts contained in this Annual Report on Form 10-K including statements regarding our future results of operations or financial condition, business strategy and plans and objectives of management for future operations, are forward-looking statements. In some cases, you can identify forward-looking statements because they contain words such as “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will” or “would” or the negative of these words or other similar terms or expressions. These forward-looking statements include, but are not limited to, statements concerning the following:
| ● | the timing, progress and results of our clinical trials of our product candidates, including statements regarding the timing of initiation and completion of studies or trials and related preparatory work, the period during which the results of the trials will become available and our research and development programs; |
| ● | our ability to continue to develop innovative, proprietary products that address significant clinical needs in a manner that is safe and effective for patients and easy-to-use for physicians; |
| ● | our ability to obtain and maintain regulatory clearances or approvals; |
| ● | our ability to demonstrate safety and effectiveness in our sponsored and third-party clinical trials; |
| ● | our ability to increase physician awareness; |
| ● | our ability to obtain and maintain coverage and adequate reimbursement for procedures using our products; |
| ● | our ability to attract and retain skilled research, development, sales and clinical personnel; |
| ● | our ability to cost-effectively manufacture, market and sell our products; |
| ● | our estimates of our market opportunity; |
| ● | our expectations regarding the scope of protection from intellectual property rights covering our products; |
| ● | timing of and results from our clinical trials and other studies; |
| ● | marketing clearances and authorization from the FDA and regulators in other jurisdictions; |
| ● | timing of regulatory filings and feedback; |
| ● | competition in the markets we serve; |
| ● | our expectations of the reliability and performance of our products; |
| ● | our expectations of the benefits of our products to patients, providers, and payors; |
| ● | the impact of proposed tariffs on our business, including the impact on gross margins related to our international product sales and the impact of resulting economic uncertainty on demand for our products; |
| ● | our reliance on a limited number of suppliers, including sole source suppliers, which may impact the availability of instruments and materials; |
| ● | our ability to sustain or increase demand for our products; |
| ● | our estimates regarding our costs and risks associated with our international operations and expansion; |
| ● | the effects of our corporate prioritization initiative and our expectations regarding our ability to retain and recruit key personnel; |
| ● | our ability to attract and retain employees, including those with specialized skills and experience; |
| ● | our expectations regarding strategic operations; |
| ● | our ability to access capital markets; |
| ● | our ability to fund our working capital requirements; |
| ● | our compliance with, and the cost of, federal, state, and foreign regulatory requirements; |
| ● | anticipated trends and challenges in our business and the markets in which we operate; and |
You should not rely on forward-looking statements as predictions of future events. The outcome of the events described in these forward-looking statements is subject to risks, uncertainties and other factors described under the header “Risk Factors” and elsewhere in this Annual Report on Form 10-K. Moreover, we operate in a very competitive and rapidly changing environment. New risks and uncertainties emerge from time to time, and it is not possible for us to predict all risks and uncertainties that could have an impact on the forward-looking statements contained herein. The results, events and circumstances reflected in the forward-looking statements may not be achieved or occur, and actual results, events or circumstances could differ materially from those described in the forward-looking statements.
The forward-looking statements made in this Annual Report on Form 10-K relate only to events as of the date on which the statements are made, and we undertake no obligation to update them to reflect events or circumstances after the date of this Annual Report on Form 10-K or to reflect new information or the occurrence of unanticipated events, except as required by law.
Risk Factor Summary
Below is a summary of material factors that make an investment in our common stock speculative or risky. This summary does not address all of the risks that we face. Additional discussion of the risks summarized in this risk factor summary, and other risks that we face, can be found under the heading “Risk Factors” in Item 1A of Part I of this Annual Report and should be carefully considered, together with other information in this Annual Report and our other filings with the U.S. Securities and Exchange Commission (“SEC”) before making investment decisions regarding our common stock.
Risks Related to Our Business
| ● | We have incurred net losses and our financial conditions raise substantial doubt about our ability to continue as a going concern. |
| ● | We may need to raise additional capital to fund our development and commercialization plans. |
| ● | Changes in our business strategy or restructuring of our businesses may increase our costs or otherwise affect the profitability of our businesses or the value of our assets. |
| ● | Our growth and revenue prospects depend on our ability to accelerate the commercialization of our products. |
| ● | Our operating results may fluctuate significantly, which makes our future operating results difficult to predict. |
| ● | There is no assurance that we will be able to execute on our business model. |
| ● | The size of the markets for our products may be smaller than estimated, limiting our ability to successfully sell products. |
| ● | Significant disruption in our information technology systems or security incidents could adversely affect us. |
| ● | We may be unable to manage our anticipated growth effectively. |
| ● | Acquisitions or strategic partnerships could increase our capital requirements and otherwise disrupt our operations. |
| ● | If we are unable to recruit and retain key executives and scientists, we may be unable to achieve our goals. |
| ● | Consolidation in the medical device industry could have an adverse effect on our revenue and results of operations. |
| ● | Unfavorable U.S. or global economic conditions could adversely affect us. |
| ● | Incorrect estimates or judgments relating to our critical accounting policies could cause a decline in our stock. |
| ● | Unavailable or inoperable facilities could adversely affect our business plans. |
Risks Related to Our Products
| ● | If our clinical trials are unsuccessful, significantly delayed or incomplete, our business may be harmed. |
| ● | Planned trials may not establish an adequate safety or efficacy profile for our products, which would affect market acceptance of our products. |
| ● | Failure to establish relationships with partners may affect the commercialization of our products. |
| ● | Failure to establish an effective network for commercialization may adversely affect our business. |
| ● | Failure to appropriately train physicians and select patients may negatively affect our products. |
| ● | If we fail to improve our products or introduce new products, our prospects could be harmed. |
| ● | Failure to establish manufacturing capacity could delay commercialization of our products. |
| ● | Difficulties with third-party suppliers and manufacturers could harm our business. |
| ● | Our products could have unknown defects or errors, which may give rise to claims against us. |
Risks Related to Our Intellectual Property
| ● | Failure to obtain and maintain sufficient intellectual property (“IP”) protection could adversely affect us. |
| ● | Changes in U.S. law relating to intellectual property may adversely impact our business. |
| ● | We may not be able to protect our IP rights throughout the world, which could harm our business prospects. |
| ● | Expensive, time-consuming IP lawsuits may prevent or delay our efforts. |
| ● | Issued patents covering our products could be found invalid or unenforceable if challenged and could materially impact our business. |
| ● | Failure to protect our trade secrets could materially, adversely affect the value of our technology. |
| ● | We may not be able to protect and enforce our trademarks and trade names or build name recognition. |
| ● | There are no assurances that we will obtain the necessary approvals from the U.S. Food and Drug Administration (“FDA”). |
| ● | We may be subject to enforcement action if we engage in improper or off-label marketing or promotion. |
| ● | Adverse findings in post-marketing vigilance or regulatory audits could materially and adversely us. |
| ● | We may be subject to enforcement action if we engage in improper marketing of our products. |
| ● | Our actual or perceived failure to comply with regulations could harm our business. |
Risks Related to Litigation and Regulation
| ● | Failure to comply with laws and regulations could result in litigation and substantially harm our business. |
| ● | We are subject to risks relating to disputes and other legal proceedings, product liability lawsuits, that may be time consuming and costly. |
| ● | Failure to comply with applicable international trade and sanctions regulations may harm our business. |
Risks Related to Financing Transactions
| ● | There are risks associated with our convertible notes that could adversely affect our financial condition. |
| ● | We are subject to risks relating to increased interest rates and adverse developments in the credit markets. |
Risks Related to Tax
| ● | Our ability to use NOL carryforwards and other tax attributes may be limited. |
| ● | The 1% U.S. federal excise tax could be imposed on us in connection with redemptions by us of our stock. |
| ● | Any changes in tax law, or in the application thereof, may adversely impact our results of operations. |
Risks Related to Ownership of Our Securities
| ● | The Perceptive PIPE Investor (defined herein) may have control over key decision making as a result of its voting power. |
| ● | We may use our financial resources in ways with which you do not agree or yield a favorable return. |
| ● | Our status as an “emerging growth company” and “smaller reporting company” could make our stock less attractive. |
| ● | Issuance of additional shares of common stock or other equity securities would dilute your ownership. |
| ● | Inaccurate or unfavorable research publication about us could decline our common stock. |
| ● | Delaware law and provisions in our Charter and Bylaws could make a merger, tender offer, or proxy contest difficult, thereby depressing the trading price of our common stock. |
| ● | The Court of Chancery of the State of Delaware serving as the exclusive forum for disputes could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers or employees. |
