Core Insights - Orchestra BioMed is focused on executing the BACKBEAT global pivotal study, which aims to establish AVIM therapy as a new standard of care for uncontrolled hypertension in pacemaker patients [2][5] - The company is also preparing to initiate a U.S. coronary pivotal study for the Virtue SAB program, with an updated trial design currently under FDA review [2][5] - The company is entering a formal mediation process with Terumo to resolve partnership negotiations, aiming for a resolution in the second quarter of 2025 [2][5] Financial Results for 2024 - Cash and cash equivalents and marketable securities totaled $66.8 million as of December 31, 2024 [10] - Revenue for 2024 was $2.6 million, a decrease from $2.8 million in 2023, primarily due to reduced partnership revenues from Terumo [10] - Research and development expenses increased to $42.8 million in 2024 from $33.8 million in 2023, driven by costs associated with the BACKBEAT study [10] - The net loss for 2024 was $61.0 million, or ($1.66) per share, compared to a net loss of $49.1 million, or ($1.48) per share, in 2023 [10][17] Product Development and Partnerships - AVIM therapy has shown promising results in pilot studies, with net reductions of 8.1 mmHg in 24-hour ambulatory systolic blood pressure and 12.3 mmHg in office systolic blood pressure at six months [8] - Virtue SAB is designed to deliver an extended-release formulation of sirolimus during balloon angioplasty without the need for a coating on the balloon surface [9] - The FDA has granted Breakthrough Device designation to Virtue SAB for specific indications, enhancing its development prospects [11] Leadership and Governance - The board of directors has been enhanced with the appointment of three experienced independent directors, including former executives from Medtronic and Siemens [5] - Mark Pomeranz has been appointed as Executive Vice President & General Manager, bringing over two decades of experience in medical devices [5]
Orchestra BioMed Reports Full Year 2024 Financial Results and Provides a Fourth Quarter Business Update