Core Insights - Orchestra BioMed Holdings, Inc. presented key clinical insights on AVIM therapy for high-risk hypertension at the CSI 2025 Meeting, emphasizing its potential to address hypertensive heart disease, a significant cardiovascular syndrome affecting an aging population [1][6] Company Overview - Orchestra BioMed is a biomedical innovation company focused on accelerating high-impact technologies through risk-reward sharing partnerships with leading medical device companies [5] - The company’s lead product candidate is AVIM therapy, designed for hypertension, which is a leading risk factor for mortality worldwide [5][8] AVIM Therapy Insights - AVIM therapy is a novel, device-based approach specifically targeting patients with hypertensive heart disease, who are at increased risk for major adverse cardiac events and currently lack sufficient therapeutic options [2][3] - The therapy aims to reduce cardiac preload and modulate autonomic nervous system responses to lower blood pressure and improve cardiovascular function, representing a potential paradigm shift in blood pressure management [3][4] Clinical Data and Studies - Pilot studies have shown that AVIM therapy resulted in 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 compared to control patients [10] - The BACKBEAT global pivotal study is currently enrolling patients with uncontrolled hypertension who are indicated for a dual-chamber pacemaker, in collaboration with Medtronic [7][10] Market Opportunity - Hypertensive heart disease affects over 7.7 million patients in the U.S., highlighting a significant market opportunity for AVIM therapy, especially given its recent FDA Breakthrough Device Designation [6][10]

Core Insights - Orchestra BioMed Holdings, Inc. reported financial results for Q1 2025, highlighting regulatory progress and a strengthening clinical pipeline [1][4] - The company received FDA Breakthrough Device Designation for its AVIM therapy, indicating significant recognition of its potential in treating hypertensive heart disease [3][6] - The company is advancing its clinical trials, including the BACKBEAT global pivotal study in collaboration with Medtronic and the initiation of the Virtue Trial for its Virtue SAB product [3][6] Financial Performance - Revenue for Q1 2025 was $0.9 million, an increase from $0.6 million in Q1 2024, primarily due to partnership revenues from Terumo [12] - Research and development expenses rose to $13.5 million in Q1 2025 from $9.1 million in Q1 2024, driven by costs associated with the BACKBEAT study [12] - The net loss for Q1 2025 was $18.8 million, or $0.49 per share, compared to a net loss of $13.5 million, or $0.38 per share, in Q1 2024 [12][19] Regulatory Developments - The FDA granted Breakthrough Device Designation for AVIM therapy, which aims to improve outcomes for patients with uncontrolled hypertension [6][10] - The company received FDA IDE approval for the Virtue SAB U.S. pivotal trial, which will compare its investigational product against a commercially available drug-coated balloon [6][13] Clinical Advancements - 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 [10] - The Virtue SAB is designed to deliver a proprietary extended-release formulation of sirolimus, demonstrating positive clinical data in coronary in-stent restenosis [11][13] Strategic Partnerships - Orchestra BioMed has strategic collaborations with Medtronic for AVIM therapy and Terumo for Virtue SAB, enhancing its commercialization efforts [8][10] - The company continues to expand its intellectual property portfolio, with 137 issued patents worldwide related to AVIM therapy [6]

Summary of Orchestra BioMed Holdings (OBIO) Conference Call Company Overview - **Company**: Orchestra BioMed Holdings (OBIO) - **Focus**: Biomedical innovation company specializing in high-impact medical device therapies through strategic partnerships [2][3] Core Technologies - **AVIM Therapy Program**: - Treatment for hypertension delivered via an implantable pulse generator (pacemaker) [2][3] - Significant blood pressure reduction observed in clinical studies, with a 11 mmHg reduction in systolic blood pressure at six months [7][8] - No major adverse cardiac events reported in treatment group [9] - **Virtu's Sirolimus Angio Infusion Balloon**: - Combines drug and device for treating coronary and peripheral artery disease [3][32] - Recently received IDE approval for a pivotal head-to-head study against a competing product [32][36] Market Potential - Both programs target established multibillion-dollar markets with significant unmet needs [3] - AVIM therapy has a potential addressable patient population of approximately 8 million in the U.S. with uncontrolled hypertension [20][27] - Breakthrough designation for AVIM therapy could lead to additional reimbursement opportunities, with potential revenue share of up to $1,600 per device [30][31] Clinical Study Insights - **AVIM Therapy**: - Pivotal study design adjustments made to optimize patient evaluation and enrollment [10][14] - Collaboration with Medtronic enhances regulatory interactions and study execution [15][21] - **Virtu's SAB**: - Head-to-head study design allows for showcasing product advantages and regulatory approval probability [36][40] - Focus on delivering a higher drug payload compared to existing products [38][39] Regulatory Interactions - Positive interactions with the FDA noted, with timely approvals and thoughtful communication [43][45] - Breakthrough designation and IDE approval achieved on schedule, reflecting effective collaboration with regulatory bodies [47][48] Strategic Partnerships - Partnership with Medtronic is crucial for leveraging their market presence and regulatory expertise [21][22] - Collaboration enhances Orchestra's ability to navigate complex regulatory landscapes and optimize clinical trial designs [15][21] Conclusion - Orchestra BioMed is positioned to make significant advancements in hypertension and cardiovascular disease treatment through innovative therapies and strategic partnerships, with promising clinical data and regulatory support paving the way for future growth and market entry [23][47]