Risk Factors Update Summary

• Adverse changes in global economic conditions could impact hospitals' ability to obtain credit, affecting our business.
• Added a new product, CanGarooRM, combining the envelope with antibiotics to reduce infection risk.
• Proposed amendments aim to regulate software and AI in medical devices, with postponed implementation until July 2024.
• Governance requirements and compliance efforts may impact the stock price and business operations.
• The weighted average exercise price per share increased from $9 to $37.
• Decrease in the number of bilateral breast reconstructions from 76,000 to 59,000.
• Our ability to develop and gain approval for medical products faces challenges due to regulatory changes.
• The company faces significant litigation related to the FiberCel Recall, with 80 outstanding lawsuits or claims as of 2023.
• Sale of Orthobiologics Business for approximately $14.6 million with potential additional $20 million.
• Manufacturers must now market devices with valid EU certifications under the CE mark until July 2024.
• Reduction in the use of human acellular dermal matrices from 125,000 to 98,000.
• The number of warrants outstanding to purchase Class A common stock decreased from 187,969 to 11,536,862.
• Maintaining cash in uninsured accounts exceeding limits poses risk if financial institutions fail.
• Alterations in FDA policies, introduction of new regulations, and delays may hinder product approvals.
• The number of outstanding shares of Class A common stock decreased from 11,724,831 to 11,536,862.
• The company had 54 employees in 2023, down from 164 in 2022, with leadership decreasing from 37 to 47.
• The company sold its Orthobiologics Business for $14.6 million upfront, with potential earn-out payments up to $20 million.
• The company incurred net losses of $37.7 million in 2023, compared to $32.9 million in 2022.
• Changes in policy or regulations could impose increased compliance costs, potentially leading to delays.
• The number of shares of Class A common stock authorized decreased from 1,864 to 1,501.
• Changes in financial reporting and internal controls could lead to material misstatements and affect operating results.
• The company had $23.7 million of indebtedness in 2023, compared to $24.3 million in 2022.
• Increase in the number of sales representatives from 1,200 to 1,000 for product distribution.
• Developed SimpliDerm for women's health, a biological matrix for tissue repair and reconstruction.
• Sale of Orthobiologics Business for $14.6 million with potential additional $20 million earn-out payments.
• Reliance on limited suppliers like Cook Biotech for raw materials poses risks of delays and increased costs.
• The number of shares of Class A common stock issuable upon vesting increased from 656 to 689.
• Transition from CE mark certification to compliance with the Medical Devices Regulation (MDR).
• Failure to adapt to changing requirements or maintain compliance may result in loss of marketing approval.
• Expanded distribution rights with LeMaitre Vascular for cardiovascular products, enhancing market reach.
• Failure to establish new commercial partner relationships may hinder sales growth and profitability.
• Change from 2021 to 2024 in the expiration date of CE mark certificates.
• Ongoing uncertainties in government regulations, domestically and internationally, add layers of unpredictability.
• Introduced TYKE product for neonatal patients, designed to promote healthy bone regeneration.
• Fluctuations in quarterly and annual results due to various factors may impact financial performance.
• Failure to comply with post-market regulatory responsibilities could impact financial condition and operations.
• Developed ProxiCor for cardiac tissue repair, providing a natural bio-scaffold for heart structures.
• Compliance with FDA regulations and quality control is crucial to avoid adverse regulatory actions.
• Submitted a 510(k) premarket notification for CanGarooRM, a drug-eluting biomatrix product.
• Violations of fraud and abuse laws could result in substantial penalties, impacting financial results.