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]

NEW HOPE, Pa., April 28, 2025 (GLOBE NEWSWIRE) -- Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO, “Orchestra BioMed” or the “Company”), a biomedical company accelerating high-impact technologies to patients through risk-reward sharing partnerships, today announced that company management will participate in multiple upcoming institutional investor conferences. Details on the Company’s participation appear below: Chardan Capital’s Trending Issues in Drug Development Conference – April 29, 2025 (Virtual) David ...

Orchestra BioMed Holdings, Inc. (OBIO) came out with a quarterly loss of $0.43 per share in line with the Zacks Consensus Estimate. This compares to loss of $0.37 per share a year ago. These figures are adjusted for non-recurring items. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. Orchestra BioMed Holdings, Inc. Shares have added about 10% since the beginn ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from __________________ to __________________ Commission file number: 001-39421 ORCHESTRA BIOMED HOLDINGS, INC. (Exact name of registrant as specified i ...

NEW HOPE, Pa., Feb. 20, 2025 (GLOBE NEWSWIRE) -- Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO, “Orchestra BioMed” or the “Company”), a biomedical company accelerating high-impact technologies to patients through risk-reward sharing partnerships, today announced that company management will present and be available for one-on-one meetings at multiple upcoming investor conferences. Details on the Company’s presence at these conferences are shown below. Presentations TD Cowen 45th Annual Healthcare Conference ...

The BACKBEAT global pivotal study is currently enrolling patients to evaluate the efficacy and safety of atrioventricular interval modulation (“AVIM”) therapy for patients who have uncontrolled hypertension and a pacemaker indicationA globally recognized thought leader and innovator in cardiovascular technologies, including electrophysiology and cardiac rhythm management, Dr. Reddy currently serves as the Director of Cardiac Arrhythmia Services at The Mount Sinai Fuster Heart Hospital, the Director of Elect ...

Late-breaking oral presentation features echocardiographic data analysis showing favorable impact of AVIM therapy on MODERATO II study patients with diastolic dysfunction, a key component in the development of heart failureHypertension is the leading cause of diastolic dysfunction; both conditions are common in older patients and contribute to the development of heart failure NEW HOPE, Pa., Feb. 12, 2025 (GLOBE NEWSWIRE) -- Orchestra BioMed Holdings, Inc. (NASDAQ:OBIO) ("Orchestra BioMed" or the "Company"), ...

Medical device industry veteran brings over three decades of expertise in M&A, as well as structured research and development (“R&D”) collaborations aligned with Orchestra BioMed’s partnership-enabled business model Mr. Cleary previously served as Senior Vice President (“SVP”) of Corporate Development at Medtronic plc (NYSE: MDT) (“Medtronic”), where he played a key role in establishing the strategic collaboration between Orchestra BioMed and Medtronic for atrioventricular interval modulation (“AVIM”) thera ...

NEW HOPE, Pa., Nov. 26, 2024 (GLOBE NEWSWIRE) -- Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO, “Orchestra BioMed” or the “Company”), a biomedical company accelerating high-impact technologies to patients through risk-reward sharing partnerships, today announced that company management will present and be available for one-on-one meetings at the Piper Sandler 36th Annual Healthcare Conference being held in New York, NY from December 3-5, 2024. Details of the presentation are shown below. Format: Fireside Ch ...

Orchestra BioMed Holdings, Inc. (OBIO) came out with a quarterly loss of $0.41 per share versus the Zacks Consensus Estimate of a loss of $0.44. This compares to loss of $0.38 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of 6.82%. A quarter ago, it was expected that this company would post a loss of $0.41 per share when it actually produced a loss of $0.45, delivering a surprise of -9.76%.Over the last four quarters, the compa ...