Risk Factors Update Summary

• Accumulated deficit increased from $607 million to $668 million as of December 31, 2023.
• The company may explore additional funding through potential equity and/or debt financing arrangements, with no current commitments in place.
• Products may face refusal or reduced coverage by third-party payers, impacting profitability.
• Net loss decreased from $62 million to $61 million, with negative cash flows from operations decreasing from $48 million to $40 million.
• Indebtedness increased from $56 million to $67.6 million, primarily comprised of a $67.6 million aggregate principal amount of 5.00% Notes.
• The company's ability to repay indebtedness is uncertain, with potential impacts on financial performance, cash flow, and ability to continue operations.
• Sequestration cuts of 2% reimposed until 2031, affecting Medicare reimbursements and future sales.
• Cash and cash equivalents decreased from $45 million to $13 million, with working capital decreasing from $12.4 million to $2 million.
• Failure to address outstanding debt obligations may lead to bankruptcy filing, restructuring, or discontinuation of operations.
• Regulatory changes may impact product clearance, approval, and classification, potentially affecting market demand.
• Increased authorized shares could lead to significant dilution, affecting stock price and ownership concentration.
• Delisting of common stock could occur due to failure to meet Nasdaq listing standards.
• Provisions in the certificate of incorporation and bylaws may delay or prevent acquisitions.
• Global economic conditions may remain challenging, impacting market access and interest rates.