Risk Factors Update Summary

• Initiating and completing clinical trials for future products will be time-consuming and expensive, affecting business prospects.
• Accumulated deficit increased from $860 million to $939.4 million, working capital decreased from $76 million to $23.8 million.
• FDA finalized a rule to replace QSR with ISO 13485 by February 2026, impacting compliance.
• Need for additional financing highlighted, with plans for equity sales, loans, collaborations, or asset sales.
• Emphasis on the need for substantial funding for product advancement and business objectives.
• Risks related to cybersecurity and data breaches, highlighting potential disruptions and liabilities.
• Failure to comply with GDPR and national data protection laws may result in fines up to 4% of the preceding financial year.
• Plans to raise capital for the LUNA System program, with potential need for bankruptcy protection.
• Focus on developing the LUNA System, with potential adverse effects if unsuccessful.
• Changes in healthcare law and policy, including Medicare changes, may impact business unpredictably.
• Increased competition in surgical robotics and digital surgery industries, impacting business operations.
• Laws and regulations regarding privacy rights and data protection may increase costs and harm business.
• Non-compliance with customers' specific requirements may lead to contract termination and legal liabilities.
• Compliance with self-regulatory standards may place additional burdens on the company and its customers.