Risk Factors Update Summary

• Net losses increased from $168.7 million to $729.6 million, with accumulated deficit rising from $595 million to $729 million.
• Increased regulatory oversight in the EU may raise costs and requirements for placing innovative medical devices in the market.
• Added risks related to AI, data privacy, IP, and security, including unintended data transmission and operational vulnerabilities. This change might result in increased operational risks and potential data breaches.
• Research and development expenses increased from 21% to 30% of product and technology revenue.
• Failure to establish and maintain adequate sales, marketing, and distribution capabilities may reduce future revenue.
• Increased risks related to cyber-attacks, including unauthorized access to personal information, disruptions in operations, and theft of IP. This change might result in significant business disruption and financial losses.
• Increased competition from top five legacy cart manufacturers may impact market share and financial performance.
• Regulatory requirements and compliance costs for foreign operations may increase, impacting financial condition.
• Expanded risks related to cybersecurity incidents, highlighting potential harm to customers, business interruptions, data loss, and litigation expenses. This change could result in financial and reputational damage.
• Failure to attract, retain, and motivate key personnel could hinder achieving company goals.
• Noted potential adverse effects of healthcare industry cost-containment measures on sales, operational costs, and customer reimbursement. This change could lead to reduced sales and operational challenges.
• Mentioned risks related to intellectual property protection, including challenges defending patents, licensing disputes, and potential infringement lawsuits. This change could impact competitive advantage and result in increased legal costs.
• Disclosed risks associated with patent litigation, emphasizing the potential financial and time-consuming nature of lawsuits. This change could lead to increased expenses and diversion of resources.
• Highlighted risks related to securities, including dilution from warrant exercises and changes in fair value impacting net income. This change could affect market price and financial reporting effectiveness.