Some of the statements contained in this Annual Report on Form 10-K (“Annual Report”) may constitute “forward-looking statements” for purposes of the federal securities laws. Our forward-looking statements include, but are not limited to, statements regarding our or our management team’s expectations, hopes, beliefs, intentions or strategies regarding the future. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “would” and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking.
| ● | Our failure to recognize the anticipated benefits of the Business Combination (refer to “Description of the Merger” for additional details), which may be affected by, among other things, competition and our ability to grow and manage growth profitably and retain our key employees; |
| ● | We are a medical device company that has incurred net losses in every period to date and expect to continue to incur significant losses as we develop our business; |
| ● | Our growth prospects partially depend on our ability to accelerate the commercialization of our products and to capitalize on market opportunities; |
| ● | Even if we are able to launch our pipeline portfolio successfully, we may experience material delays in our commercialization program relative to our current expectations; |
| ● | The life sciences technology market is highly competitive. Competitors include new entrants and established companies, many of which have significantly greater resources than we do. If we fail to compete effectively, our business and results of operation will suffer; |
| ● | If we are unable to establish manufacturing capacity by ourselves or with third-party partners in a timely and cost-effective manner, commercialization of our products would be delayed, which would result in lost revenue and harm our business; |
| ● | We may not be successful in the commercialization of our products if we fail to establish relationships and successfully collaborate with leading life science companies and research institutions; |
| ● | If we are unable to establish an effective network for commercialization, including effective distribution channels and sales and marketing functions, it may adversely affect our business, financial condition, results of operations, and prospects; |
| ● | There is no assurance that we will be able to execute on our business model, including achieving market acceptance of our products; |
| ● | Our products may not be successful if there are inadequate physician training, practice and patient selection; |
| ● | Even if our products are commercialized and achieve broad scientific and market acceptance, if we fail to improve them or introduce compelling new products, our revenue and our prospects could be harmed; |
| ● | The size of the markets for our products may be smaller than estimated, limiting our ability to successfully sell our products; |
| ● | The loss of any third-party suppliers and manufacturers, or any difficulties encountered by these suppliers and manufacturers in the production of our products; |
| ● | Our failure to protect against software or hardware vulnerabilities; |
| ● | Our failure to raise additional capital to develop the business development and commercialization plans; |
| ● | The risks related to the unfavorable U.S. or global economic conditions as a result of political instability, natural disasters, or otherwise; |
| ● | The loss of one or more of our executive officers and other key employees; |
| ● | Our failure to hire and retain qualified employees; |
| ● | Our failure to comply with federal state and local laws and regulations; and |
| ● | Our inability to maintain the listing of our common stock on the Nasdaq Capital Market (“Nasdaq”). |
These forward-looking statements are based on information available as of the date of this Annual Report, reflect our management’s current expectations, forecasts and assumptions, and involve a number of judgments regarding known and unknown risks, uncertainties, and other factors, many of which are outside of our control, and the control of our directors, officers and affiliates. Accordingly, forward-looking statements should not be relied upon as representing our views as of any subsequent date. We do not undertake any obligation to update, add or to otherwise correct any forward-looking statements contained herein to reflect events or circumstances after the date they were made, whether as a result of new information, future events, inaccuracies that become apparent after the date hereof or otherwise, except as may be required under applicable securities laws.
As a result of a number of known and unknown risks and uncertainties, our results or performance may be materially different from those expressed or implied by these forward-looking statements. Some factors that could cause actual results to differ are set forth under the heading “Risk Factor Summary” below and those described under Part I, Item 1A “Risk Factors” of this Annual Report.
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 not be able to successfully execute our new business strategy and strategic restructuring. |
| ● | Changes in our business strategy or restructuring of our businesses may affect the profitability of our business. |
| ● | 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. |
| ● | We may need to raise additional capital to fund our development and commercialization plans. |
| ● | Our product market size 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 partnership 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 adversely effect on our revenue and results of operations. |
| ● | Unfavorable U.S. or global economic conditions could adversely affect us. |
| ● | Failure to maintain an effective system of internal control over financial reporting could harm our business. |
| ● | Incorrect estimates or judgments relating to our critical accounting policies could cause a decline in our stock. |
| ● | We are not in compliance with Nasdaq’s requirements, which affect the liquidity of our common stock. |
| ● | Unavailable or inoperable facilities could adversely affect our business plans. |
| ● | Any claims relating to improper handling, storage or disposal of hazardous materials could be costly. |
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 would 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, the value of our technology could be materially adversely affected. |
| ● | We may not be able to protect and enforce our trademarks and trade names or build name recognition. |
| ● | Patent terms may be inadequate to protect our competitive position of our products. |
| ● | Our patent protection could be reduced or eliminated for non-compliance with these requirements. |
| ● | We may be subject to claims that confidentiality or misappropriation claims. |
| ● | Failure to license rights to use technologies may affect commercialization of new products in the future. |
| ● | Failure to comply with the terms of the underlying open source software licenses could limit us. |
| ● | IP rights do not necessarily address all potential threats. |
| ● | There are no assurances that we will obtain the necessary approvals from the U.S. Food and Drug Administration (“FDA”) in the United States. |
| ● | 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. |
| ● | Failure to comply with anti-corruption, anti-bribery and anti-money laundering and similar laws could adversely affect our reputation, business, financial condition and results of operations. |
| ● | Expansion will subject us to an increased risk of inadvertent violation the Foreign Corrupt Practices Act. |
| ● | Noncompliance with regulatory standards and requirements 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 no guarantees that we can obtain future investments at a reasonable cost or at all. |
| ● | 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. |
| ● | Status as “emerging growth company” and “smaller reporting company” could make our stock not attractive. |
| ● | Our stock price may be volatile and may decline regardless of its operating performance. |
| ● | Issuance of additional shares of common stock or other equity securities would dilute your ownership. |
| ● | Inaccurate or unfavorable research publication about 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 its common stock. |
| ● | Court of Chancery of the State of Delaware 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. |
| ● | We will incur increased costs and obligations as a result of being a public company. |
| ● | The requirements of being a public company may strain our resources and negatively impact our business. |
| ● | Failure to have effective internal control over financial reporting could cause our common stock to decline. |
| ● | Failure to remediate these material weaknesses may adversely affect our business and stock price. |
| ● | Securities or class action litigation would be expensive and could divert management’s attention. |
| ● | The lack of published research or reports about us or published negative reports may impact our stock price. |
| ● | Changes in laws or regulations or how such laws or regulations are interpreted or applied, or a failure to comply with any laws or regulations, may adversely affect our business and results of operations. |
