Tue, Mar 25, 9:01 PM (32 days ago)
### Summary **Financial Performance:** - **Revenue:** $0 (no revenue generated). - **Net Income:** Negative $11,443,000 (net loss for 2024). - **Operating Expenses:** $11,625,000 (operating loss for 2024). - **Earnings per Share:** Negative $0.73 (basic and diluted net loss per share for 2024). **Strategic Overview:** - **Product Focus:** LIBERTY® Endovascular Robotic Surgical System, designed for minimally invasive surgery. - **Market Position:** Targeting the minimally invasive surgery space, with a focus on endovascular interventions. - **Competitive Landscape:** Main competitors include CorPath GRX and Robocath's R-One+. **Future Outlook:** - **Regulatory Milestones:** Anticipating FDA marketing clearance in Q2 2025 and U.S. commercialization activities post-clearance. - **Market Expansion:** Seeking CE Mark approval in H2 2026 for European and other regions. - **Funding:** Raised approximately $30.6 million post-December 31, 2024, with plans to continue raising capital through equity and debt offerings. **Risk Factors:** - **Financial Condition:** High operating losses and negative cash flows, dependent on raising additional funds. - **Regulatory Risks:** Uncertainty regarding FDA and CE Mark approvals, and potential delays or failures in regulatory processes. - **Operational Risks:** Dependence on third-party manufacturers and suppliers, potential supply chain disruptions, and geopolitical risks in Israel. **Market Position Changes:** - **Competitive Landscape:** Facing competition from established and emerging robotic systems in the endovascular space. - **Market Acceptance:** Dependent on demonstrating the safety, efficacy, and cost-effectiveness of the LIBERTY® system. **Financial Condition:** - **Cash and Cash Equivalents:** $3,114,000 as of December 31, 2024. - **Marketable Securities:** $2,356,000 as of December 31, 2024. - **Operating Lease Liabilities:** $111,000 as of December 31, 2024. **Note:** Amounts are in thousands of dollars.