Risk Factors Update Summary

• Limited preclinical experience in animal models of cardiac disease. Limited clinical experience treating AF with CellFX nsPFA 360° Cardiac Catheter. This may impact the success of new products.
• Added detailed risks related to employee misconduct and illegal activities, including federal laws with significant penalties.
• Reduction in full-time sales and marketing positions. No U.S. or international sales force as of December 31, 2023. Limited experience marketing and selling the CellFX System.
• Inclusion of the U.S. Physician Payments Sunshine Act and the California Consumer Privacy Act (CCPA) with potential impacts on operations.
• Dependence on third parties for sales, marketing, manufacturing, and distribution activities. Reliance on third parties may reduce control and lead to delays or failure in product development.
• Expanded risks related to anti-corruption laws, FCPA violations, and compliance costs with international operations.
• Difficulty in enrolling patients for clinical trials. Enrollment challenges may delay regulatory authorizations for new products.
• Intellectual property rights may not be sufficient to prevent competition. Additional costs and changes in manufacturing processes could result.
• Changes in healthcare policy could increase costs and subject the company to additional regulatory requirements. Impact on sales and reimbursement for current and future solutions.