▸ If our research and development facility is damaged or becomes inoperable, we will be unable to continue to research and develop our product candidates and delays in our product development could result in an adverse effect on our business.· · · · ● 1 ▸ If we do not obtain patent term extension in the United States under the Hatch-Waxman Amendments, thereby potentially extending the term of marketing exclusivity for our product candidates, our business may be materially harmed.· · · · ● 1 ▸ If we fail to successfully develop, commercialize, market and sell NXT-41x, the Company’s business and financial condition may be materially adversely affected.· · · · ● 1 ▸ Our future results largely depend upon our ability to successfully develop, commercialize, market and sell breast reconstruction biologic products.· · · · ● 1 ▸ Our officers, employees, independent contractors, principal investigators, consultants and independent sales agents may engage in misconduct or activities that are improper under other laws and regulations, which would create liability for us.· · · · ● 1 ▸ We may not be able to maintain a listing of our Class A common stock on the Nasdaq Capital Market.· · · · ● 1 ▸ We face significant litigation related to our FiberCel and Viable Bone Matrix recalls and have no more insurance coverage on the FiberCel recall.· · · ● ● 2 rw ▸ Actual or perceived failure to comply with data protection laws and regulations could lead to government enforcement actions, private litigation and/or adverse publicity and could negatively affect our business.· · ● ● ● 3 ▸ If we fail to comply with these rules and regulations, we could be subject to a number of penalties, including the delisting of our Class A common stock, fines, sanctions or other regulatory action or civil litigation.· · ● ● ● 3 ▸ We may not realize all of the potential consideration associated with the sale of our Orthobiologics Business.· · ● ● ● 3 rw ▸ Adverse changes in general domestic and global economic conditions and instability and disruption of credit markets could adversely affect our business, financial condition, results of operations and liquidity.· ● ● ● ● 4 ▸ Any of these sanctions could result in higher than anticipated costs or lower than anticipated sales and have a material adverse effect on our reputation, business, financial condition and results of operations.· ● ● ● ● 4 ▸ We have incurred operating losses and may continue to do so in the near-term, and we cannot assure that we will be able to generate sufficient revenue to achieve or sustain profitability.· ● ● ● ● 4 rw ▸ Our future results depend upon our ability to successfully commercialize, market and sell our newly approved EluPro antibacterial envelope device and the success of a smaller suite of established products than has historically been the case.· · · ● · 1 ▸ Our future results depend upon the success a smaller suite of established products than has historically been the case in the past, and upon the success of our CanGarooRM product, which has not yet been approved for sale.· · ● · · 1 ▸ We face significant risks related to our Viable Bone Matrix recall.· · ● · · 1 ▸ Our business has been, and may continue to be, adversely affected by the COVID-19 pandemic, and we may be adversely affected by any future pandemic, epidemic or outbreak of an infectious disease in the United States or worldwide.· ● · · · 1 ▸ We have identified conditions and events that raise substantial doubt regarding our ability to continue as a going concern.· ● ● ● · 3 ▸ A significant portion of our total outstanding shares are eligible to be sold into the market in the near future, which could cause the market price of our Class A common stock to drop significantly, even if our business is doing well.● ● ● ● · 4 ▸ As we conduct clinical studies designed to generate long-term data on some of our existing products, the data we generate may not be consistent with our existing data and may demonstrate less favorable safety or efficacy.● ● ● ● · 4 ▸ Certain of our products are dependent on the availability of tissue from human donors, and any disruption in supply could adversely affect our business, financial condition and results of operations.● ● · · · 2 ▸ Failure to comply with post-marketing regulatory requirements could subject us to enforcement actions, including substantial penalties, and might require us to recall or withdraw a product from the market.● ● ● ● · 4 ▸ Our indebtedness and our Revenue Interest Obligation to Ligand Pharmaceuticals Incorporated may limit our flexibility in operating our business and adversely affect our financial health and competitive position.● ● ● ● · 4 ▸ Our principal stockholders have significant voting power and may take actions that may not be in the best interests of our other stockholders.● ● ● ● · 4 ▸ Our sales into foreign markets expose us to risks associated with international sales and operations.● ● ● · · 3 ▸ Our success depends on our ability to maintain the value and reputation of the Aziyo name.● · · · · 1 ▸ group Risks Related to Our Common Stock● ● ● ● · 4 ▸ The dual class structure of our common stock and the option of the holders of shares of our Class B common stock to convert into shares of our Class A common stock may limit your ability to influence corporate matters.● ● ● ● · 4 ▸ The processing of porcine tissue for our products is technically complex, requiring high levels of quality control and precision, which subjects us to increased production risks.● ● ● ● · 4 rw ▸ Uncertainty relating to the LIBOR calculation process and potential phasing out of LIBOR after 2021 may adversely affect the market value of our current or future debt obligations.● · · · · 1 ▸ We are a “controlled company” within the meaning of the Nasdaq Stock Market LLC (“Nasdaq”) and, as a result, qualify for, and may rely on, exemptions from certain corporate governance requirements.● · · · · 1 ▸ We are working to grow our direct sales force, which may result in higher fixed costs and may slow our ability to reduce costs in the face of a sudden decline in demand for our products.● · · · · 1 ▸ We expect that the price of our Class A common stock will fluctuate substantially and you may not be able to sell the shares you purchase at or above the price you paid for such shares.● ● · · · 2 ▸ We face significant litigation related to FiberCel.● ● ● · · 3 ▸ We have incurred operating losses since our inception, expect to continue to incur significant expenses and operating losses in the future, and may not be able to achieve or sustain profitability.● · · · · 1 ▸ We may be unable to enforce our intellectual property rights throughout the world.● ● ● ● · 4 ▸ We may face additional issues associated with the voluntary recall of the single donor lot of FiberCel if we are unable to show that we initiated a timely recall and recalled all deficient lots.● · · · · 1 ▸ We plan to expand our direct sales force coinciding with new product launches, and if we are unable to successfully expand, manage and maintain our direct sales force, we may not be able to generate greater market share and revenue growth.● · · · · 1 ▸ We will continue to incur increased costs as a result of operating as a public company, and our management is required to devote substantial time to new compliance initiatives and corporate governance practices.● ● · · · 2 rw ▸ As a public company, we are required to evaluate our internal control over financial reporting in a manner that meets the standards of publicly traded companies required by Section 404(a) of the Sarbanes-Oxley Act, or Section 404.● ● · ● ● 4 ▸ We are a “smaller reporting company,” and the reduced disclosure requirements applicable to smaller reporting companies may make our common stock less attractive to investors.● ● ● · ● 4 rw ▸ Because we do not anticipate paying any cash dividends on our common stock in the foreseeable future, capital appreciation, if any, would be your sole source of gain.● ● ● ● ● 5 ▸ Changes in accounting standards and subjective assumptions, estimates and judgments by management related to complex accounting matters could significantly affect our business, financial condition and results of operations.● ● ● ● ● 5 ▸ Changes in tax laws, unfavorable resolution of tax contingencies or exposure to additional income tax liabilities could have a material impact on our results of operations or financial condition.● ● ● ● ● 5 ▸ Failure to comply with requirements to design, implement and maintain effective internal control over financial reporting could have a material adverse effect on our business and stock price.● ● ● ● ● 5 ▸ Healthcare policy changes, including recently enacted legislation reforming the U.S. healthcare system, could harm our cash flows, financial condition and results of operations.● ● ● ● ● 5 ▸ If hospitals and other healthcare providers are unable to obtain coverage or adequate reimbursement for procedures performed with our products, it is unlikely our products will be widely used.● ● ● ● ● 5 ▸ If our operating and financial performance in any given period does not meet the guidance we provide to the public, the market price of our Class A common stock may decline.● ● ● ● ● 5 ▸ If securities or industry analysts do not publish research or reports about our business, or if they issue an adverse or misleading opinion regarding our Class A common stock, our stock price and trading volume would likely decline.● ● ● ● ● 5 ▸ If we are unable to obtain, maintain and adequately protect our intellectual property rights, our competitive position could be harmed or we could be required to incur significant expenses to enforce or defend our rights.● ● ● ● ● 5 ▸ If we are unable to protect the confidentiality of our trade secrets, our business and competitive position could be harmed.● ● ● ● ● 5 ▸ Increased prices for raw materials or supplies used in our products could adversely affect our business, financial condition and results of operations.● ● ● ● ● 5 rw ▸ New lines of business and new products and services may subject us to additional risks.● ● ● ● ● 5 ▸ Our HCT/P product is subject to extensive government regulation, and our failure to comply with these requirements could cause our business to suffer.● ● ● ● ● 5 rw ▸ Our ability to use certain tax attributes to offset future income tax liabilities may be subject to limitations.● ● ● ● ● 5 ▸ Our disclosure controls and procedures may not prevent or detect all errors or acts of fraud.● ● ● ● ● 5 ▸ Our estimates of market opportunity and forecasts of market and sales growth may prove to be inaccurate, and even if the markets in which we compete achieve the forecasted growth, our business could fail to grow at similar rates, if at all.● ● ● ● ● 5 ▸ Our future capital needs are uncertain, and we may need to raise funds in the future, and such funds may not be available on acceptable terms or at all.● ● ● ● ● 5 rw ▸ Our future growth depends on physician awareness of the distinctive characteristics, benefits, safety, clinical efficacy and cost-effectiveness of our products.● ● ● ● ● 5 ▸ Our long-term growth depends on our ability to enhance our products, expand our product indications and develop, acquire and commercialize additional product offerings.● ● ● ● ● 5 ▸ Our net sales are generated through independent sales agents, which subjects us to various risks.● ● ● ● ● 5 rw ▸ Our operating results may fluctuate significantly from quarter to quarter and year to year due to the seasonality of our business, as well as a variety of other factors, many of which are outside of our control.● ● ● ● ● 5 ▸ Our success depends on our ability to retain and motivate key management personnel and other employees and consultants, to attract, retain and motivate additional qualified personnel and to effectively navigate changes in our senior management team.● ● ● ● ● 5 ▸ Our success depends on the continued and future acceptance of our products by the medical community.● ● ● ● ● 5 ▸ Performance issues, service interruptions or price increases by our shipping carriers could adversely affect our business, harm our reputation and impair our ability to provide our products on a timely basis or at all.● ● ● ● ● 5 ▸ Pricing pressure as a result of cost-containment efforts of our customers, purchasing groups, third-party payors and governmental organizations could adversely affect our sales and profitability.● ● ● ● ● 5 ▸ Recent changes in U.S. patent laws may limit our ability to obtain, defend and/or enforce our patents.● ● ● ● ● 5 ▸ group Risks Related to Government Regulation● ● ● ● ● 5 ▸ group Risks Related to Intellectual Property● ● ● ● ● 5 ▸ group Risks Related to Our Business● ● ● ● ● 5 ▸ The patent protection we obtain for our products may not be sufficient enough to provide us with any competitive advantage or our patents may be challenged.● ● ● ● ● 5 ▸ Third parties may assert ownership or commercial rights to inventions we develop.● ● ● ● ● 5 ▸ Third parties may assert that our employees or consultants have wrongfully used or disclosed confidential information or misappropriated trade secrets.● ● ● ● ● 5 ▸ We bear the risk of warranty claims on our products.● ● ● ● ● 5 ▸ We could be subject to securities class action litigation.● ● ● ● ● 5 ▸ We face the risk of product liability claims and may not be able to obtain or maintain adequate product liability insurance.● ● ● ● ● 5 ▸ We may need to continue to expand our organization and managing growth may be more difficult than we expect.● ● ● ● ● 5 rw ▸ We may not be able to protect and enforce our trademarks and trade names, or build name recognition in our markets of interest, thereby harming our competitive position.● ● ● ● ● 5 ▸ We may not enter into invention assignment and confidentiality agreements with all of our employees and contractors and such agreements could be ineffective or breached.● ● ● ● ● 5 ▸ You may be diluted by the future issuance of additional common stock in connection with any future public or private offerings of our securities, our incentive plans, acquisitions or otherwise.● ● ● ● ● 5 rw