▸ Any reduction in reimbursement from Medicare resulting from the IRA or other legislative or policy changes, or from other government programs may result in a similar reduction in payments from private payers. These healthcare reforms and the· · · · ● 1 ▸ If we are found or alleged to have improperly promoted off-label uses, we may become subject to significant liability.· · · · ● 1 ▸ Requires manufacturers to pay rebates for a Medicare Part B or Part D drug if the price increases for the drug exceed the rate of inflation.· · · · ● 1 ▸ The terms of the Loan Agreement (defined below) may limit our ability to incur future debt.· · · · ● 1 ▸ This exclusive forum provision may limit a stockholder’s ability to bring a claim in a judicial forum that it finds favorable for disputes with us or any of our directors, officers, other employees or stockholders, which may discourage lawsuits with· · · · ● 1 ▸ We have concluded that substantial doubt is deemed to exist concerning our ability to continue as a going concern.· · · · ● 1 ▸ We have incurred significant losses to date and we expect to continue to incur losses for the foreseeable future and may never be profitable.· · · · ● 1 ▸ We may be subject to enforcement action, civil liability, regulatory investigation and penalties if we engage in the off-label promotion of Symvess.· · · · ● 1 ▸ We sell Symvess using arrangements that sometimes involve the consignment of inventory, which results in additional risk and uncertainty as to the viability of consigned inventory, inventory accounting, and tax consequences.· · · · ● 1 ▸ Changes in U.S. government policies under the Trump administration, including increased tariffs and reductions in federal research funding, could adversely affect our business.· · · ● ● 2 ▸ Symvess and our product candidates, if approved, may fail to achieve the degree of market acceptance by physicians, patients, third-party payors and others in the medical community necessary for commercial success.· · · ● ● 2 ▸ We are and may continue to be subject to legal and other proceedings that could cause us to incur significant expenses, divert our management’s attention, and materially harm our business, financial condition, and operating results.· · · ● ● 2 ▸ We cannot predict how further developments of or changes to these laws and regulations will affect our business.· · ● ● · 2 ▸ Even if we do achieve profitability, we may not be able to sustain or increase profitability. Our failure to become and remain profitable would depress the value of our company and could impair our ability to maintain our research and· ● · · · 1 ▸ Ineffective internal control over financial reporting could also cause investors to lose confidence in our reported financial information, which could have a negative effect on the trading price of our common stock. In connection with its· ● · · · 1 ▸ Our Charter provides that, unless we consent in writing to the selection of an alternative forum, the Court of Chancery of the State of Delaware and the federal district courts of the United States of America are the exclusive forums for· ● · · · 1 ▸ The extent to which ongoing effects of the COVID-19 pandemic impacts our business and clinical trials will depend on future developments, which are highly uncertain and cannot be predicted with confidence.· ● · · · 1 ▸ To monitor compliance with applicable regulations, the FDA routinely conducts inspections of facilities and may identify potential deficiencies. For example, the FDA issues what are referred to as “Form 483s” that set forth observations· ● · · · 1 ▸ Compliance with U.S. and international data protection laws and regulations could require us to take on more onerous obligations in our contracts, restrict our ability to collect, use and disclose data, or in some cases, impact our ability to● · · · · 1 ▸ If we experience failures or delays in our preclinical and clinical programs, we would be prevented from developing and commercializing our product candidates in a timely matter, if at all.● ● · · · 2 ▸ Our near-term prospects are dependent on the success of our 6 millimeter HAV, and if we are unable to successfully develop and commercialize it, our business, operating results and financial condition will be materially harmed.● ● ● · · 3 ▸ Our progress in early stage clinical trials may not be indicative of long-term efficacy in late stage clinical trials, and our progress in trials for one product candidate may not be indicative of progress in trials for another product candidate.● ● ● · · 3 ▸ Should any of these events occur, they could harm our business, financial condition, results of operations, and prospects.● ● ● ● · 4 ▸ The ongoing effects of the COVID-19 pandemic may continue to adversely impact our business, including our manufacturing efforts and clinical trials.● ● · · · 2 rw ▸ To date, we have obtained marketing approval for, and begun commercializing, only one product, which may make it difficult for you to evaluate the success of our business to date and to assess our future viability.● ● ● ● · 4 rw ▸ group Vascular graft complication 1(3)%● ● · · · 2 ▸ Our ability to successfully commercialize Symvess and our product candidates may be impaired if we are unable to obtain and maintain effective intellectual property rights for our proprietary scientific technology platform and product candidates.● ● ● · ● 4 rw ▸ Any of these events could cause us to incur significant additional costs, significant delays and prevent us from achieving or maintaining market acceptance of or commercializing one or more of our product candidates.● ● ● ● ● 5 ▸ Because we do not anticipate paying any cash dividends on our common stock in the foreseeable future, capital appreciation, if any, will be your sole source of gains and you may never receive a return on your investment.● ● ● ● ● 5 ▸ Healthcare reform measures could hinder or prevent commercial success of Symvess or our product candidates.● ● ● ● ● 5 rw ▸ If SAEs occur at an unacceptable rate or other unacceptable side effects are identified in our ATEVs we may need to delay, abandon or limit development and marketing of our product candidates.● ● ● ● ● 5 rw ▸ If our trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our marks of interest and our business may be adversely affected.● ● ● ● ● 5 ▸ If we fail to comply with environmental, health and safety laws and regulations, we could become subject to fines and penalties or incur costs that could harm our business.● ● ● ● ● 5 ▸ If we fail to comply with healthcare regulations, we could face substantial penalties and our business, prospects, operating results and financial condition could be adversely affected.● ● ● ● ● 5 ▸ If we fail to comply with our obligations in our intellectual property licenses with third parties, we could lose license rights that are important to our business.● ● ● ● ● 5 ▸ Intellectual property rights do not necessarily address all potential threats.● ● ● ● ● 5 ▸ Lack of experience by investigators and surgeons with our ATEVs can lead to incorrect implantation or follow-up procedures which could harm the results of our clinical trials and market acceptance of Symvess and our product candidates.● ● ● ● ● 5 rw ▸ Manufacturing facilities are subject to significant government regulations and approvals, which are often costly and could result in adverse consequences to our business if we fail to comply with the regulations or maintain the approvals.● ● ● ● ● 5 ▸ Our ability to use our net operating loss and tax credit carryforwards to offset future taxable income may be subject to certain limitations.● ● ● ● ● 5 ▸ Our business could be adversely impacted by inflation.● ● ● ● ● 5 ▸ Our distribution agreement with Fresenius Medical Care imposes obligations on us that may restrict our ability to operate our business in ways we believe to be in our long-term best interest.● ● ● ● ● 5 ▸ Our future success depends on our ability to retain our key employees, consultants and advisors and to attract, retain and motivate qualified personnel.● ● ● ● ● 5 ▸ Patent terms may be inadequate to protect our competitive position on Symvess or our product candidates for an adequate amount of time.● ● ● ● ● 5 rw ▸ Pending and future patent applications may not result in patents being issued that protect our business, in whole or in part, or which effectively prevent others from commercializing competitive products.● ● ● ● ● 5 ▸ Pursuant to the terms of the Loan Agreement, we may be limited in our ability to incur future debt.● ● ● ● ● 5 rw ▸ Reports published by analysts, including projections in those reports that differ from our actual results, could adversely affect the price and trading volume of our common stock.● ● ● ● ● 5 ▸ group Risks Related to Business Matters and Our Ability to Manage Growth● ● ● ● ● 5 ▸ group Risks Related to Government Regulation● ● ● ● ● 5 ▸ group Risks Related to Manufacturing Symvess and Our Product Candidates● ● ● ● ● 5 rw ▸ Risks Related to Our Financial Position and Need for Additional Funding● ● ● ● ● 5 ▸ group Risks Related to Our Intellectual Property● ● ● ● ● 5 ▸ group Risks Related to Our Reliance on Third Parties● ● ● ● ● 5 ▸ Risks Related to the Development of Symvess and Commercialization of Our Product Candidates● ● ● ● ● 5 rw ▸ The obligations associated with being a public company involve significant expenses and will require significant resources and management attention, which may divert from our business operations.● ● ● ● ● 5 ▸ The patent protection we obtain for Symvess or our product candidates may not be sufficient enough to provide us with any competitive advantage or our owned or licensed patents may be challenged.● ● ● ● ● 5 rw ▸ These market and industry factors may materially reduce the market price of our common stock, regardless of our operating performance.● ● ● ● ● 5 ▸ Third parties may assert that our employees or consultants have wrongfully used or disclosed confidential information or misappropriated trade secrets.● ● ● ● ● 5 ▸ We could also face product liability suits or regulatory delays due to defects in our products, which could be expensive and time-consuming and result in substantial damages payable by us and increases in our insurance rates.● ● ● ● ● 5 ▸ We expect to increase the size of our workforce in the future, and we may encounter difficulties in managing this growth, which could harm our operations.● ● ● ● ● 5 ▸ We expect to need to raise additional funding, which may not be available on acceptable terms, or at all, and any failure to obtain capital when needed may force us to delay, limit or terminate our product development or commercialization efforts.● ● ● ● ● 5 ▸ We have derivative securities that are accounted for as assets and liabilities and the changes in value of such derivative securities could have a material effect on our financial results.● ● ● ● ● 5 rw ▸ We may become involved in lawsuits to protect or enforce our patents, which could be expensive, time-consuming and unsuccessful.● ● ● ● ● 5 ▸ We may experience delays or difficulties in the enrollment of patients in our clinical trials, which may delay or prevent additional clinical trials and our receipt of necessary marketing approvals.● ● ● ● ● 5 ▸ We may issue additional shares of common stock or other equity securities without stockholder approval, which would dilute your ownership interests and may depress the market price of our common stock.● ● ● ● ● 5 rw ▸ We may not be able to protect our intellectual property rights throughout the world.● ● ● ● ● 5 ▸ We may not be successful in obtaining necessary intellectual property rights to product candidates for our development pipeline through acquisitions and in-licenses.● ● ● ● ● 5 ▸ We may not be successful in our efforts to use our proprietary scientific technology platform to build a pipeline of additional product candidates.● ● ● ● ● 5 ▸ We may not obtain marketing approval from the FDA for any of our product candidates even if we successfully complete our clinical trials, which failure would materially harm our business, prospects, operating results and financial condition.● ● ● ● ● 5 ▸ We may redeem your unexpired Public Warrants prior to their exercise at a time that is disadvantageous to you, thereby making your Public Warrants worth less than they would be if you held and exercised them at a later time.● ● ● ● ● 5 ▸ We or the third parties upon which we depend may be adversely affected by natural disasters, and our business continuity and disaster recovery plans may not adequately protect us from a serious disaster.● ● ● ● ● 5 
