Core Insights - Orchestra BioMed Holdings, Inc. announced an industry-sponsored satellite symposium at the Heart Rhythm Society 2025 Annual Meeting to discuss advancements in its atrioventricular interval modulation (AVIM) therapy program [1][4] - The FDA granted Breakthrough Device Designation to AVIM therapy for treating hypertension in patients with increased cardiovascular risk, highlighting the unmet need in this patient population [2][4] - The BACKBEAT global pivotal study is currently enrolling patients to evaluate the efficacy of AVIM therapy in managing uncontrolled hypertension [2][9] Company Overview - Orchestra BioMed is a biomedical innovation company focused on accelerating high-impact technologies through partnerships with leading medical device companies [7] - The company's lead product candidate is AVIM therapy, aimed at treating hypertension, which is a leading risk factor for death globally [7] - Orchestra BioMed has strategic collaborations with Medtronic for AVIM therapy and Terumo for the Virtue Sirolimus AngioInfusion Balloon [7] Symposium Details - The symposium titled "The Future of Cardiac Pacing: Unlocking the Potential of Atrioventricular Interval Modulation (AVIM) Therapy" will take place on April 25, 2025, at the Hilton San Diego Bayfront Hotel [3] - Presentations will cover clinical results from studies demonstrating AVIM therapy's effectiveness in reducing blood pressure and improving cardiac function [4][5] - Key presentations will include topics on the unmet hypertension need, AVIM therapy's impact on hypertension, and the rationale behind the BACKBEAT study [5][6] Clinical Evidence - AVIM therapy has shown promising results in pilot studies, with reductions of 8.1 mmHg in 24-hour ambulatory systolic blood pressure and 12.3 mmHg in office systolic blood pressure at six months compared to control patients [9] - The BACKBEAT study aims to further evaluate the safety and efficacy of AVIM therapy in patients with uncontrolled hypertension despite anti-hypertensive medication [9]

Core Insights - The U.S. FDA has granted Breakthrough Device Designation for Orchestra BioMed's AVIM therapy, which aims to manage hypertension in patients at high cardiovascular risk [1][3][6] Regulatory and Clinical Development - The Breakthrough Device Designation is specifically for an implantable system (pacemaker) that delivers AVIM therapy to reduce blood pressure in patients with increased ten-year ASCVD risk and uncontrolled hypertension [2][6] - There are over 7.7 million patients in the U.S. who meet the criteria for this therapy [2][6] - AVIM therapy is currently being evaluated in the BACKBEAT global pivotal study, which is a collaboration between Orchestra BioMed and Medtronic [2][3][7] Market Potential and Collaboration - The collaboration with Medtronic allows for the development and commercialization of AVIM therapy, particularly for patients indicated for pacemakers [7][8] - The Breakthrough Device Designation may facilitate favorable reimbursement pathways, including eligibility for NTAP and TPT under CMS programs [4][11] Clinical Efficacy - Pilot studies have shown that AVIM therapy can lead to significant reductions in blood pressure, 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 [10]

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]