Risk Factors Update Summary
- Accumulated deficit increased from $357 million to $400 million as of December 31, 2023.
- Adverse developments in the financial industry could lead to liquidity problems and impact operations.
- Addition of CE Certificate of Conformity under the Medical Device Regulation, impacting product clearance and business operations.
- Increased number of U.S. patents from 51 to 59 and pending applications from 32 to 34.
- Net losses decreased from $61.3 million to $43.6 million for the years ended December 31, 2022 and 2023.
- Inflation and interest rate increases may decrease the value of government securities.
- Loan agreement covenants may restrict business activities and financing, impacting operations and strategies.
- Change in Medicare physician fee reimbursement for different iFuse implants, impacting revenue streams.
- Pending foreign patent applications increased from 18 to 22, affecting global patent protection.
- Introduction of a new Category I CPT code, 27278, effective January 1, 2024, for a different sacroiliac joint procedure.
- Net operating loss carryforwards increased from $298.6 million to $331.6 million, impacting future taxable income.
- Decrease in the number of U.S. sales force employees and international sales force employees.
- Addition of the European Economic Area Consumer Data Protection Act, affecting data transfer regulations.
- Potential impact of the Inflation Reduction Act of 2022 on Medicare payments and subsidies.
- Increased number of registered trademarks in the U.S. from 19 to 20, with pending applications decreasing from 4 to 3.
- Changes in regulatory requirements in the EU under the Medical Device Regulation, impacting costs.
- Addition of the UKCA mark to replace the CE conformity mark, impacting product marketing and certification.
Full Text Changes in Most Recent 10-K
Intended use: review the highlighted statements. These are additions to the risk factors disclosure in the most recent 10-K filing compared to the previous 10-K filing. Deleted and moved text is less important and is shown for context.
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