NEW HOPE, Pa., March 03, 2026 (GLOBE NEWSWIRE) -- Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO) (“Orchestra BioMed” or the “Company”), a biomedical company accelerating high-impact technologies to patients through strategic partnerships with market-leading global medical device companies, today announced two presentations that will be given at the Technology Heart Failure and Therapeutics (“THT”) and Cardiovascular Research Technologies (“CRT”) 2026 Meetings highlighting the potential for the Company’s Atr ...

Core Viewpoint - Orchestra BioMed Holdings, Inc. is set to receive up to $21 million in cash proceeds from the acquisition of Vivasure by Haemonetics Corporation, which closed on January 9, 2026, highlighting the strategic value of Vivasure to Orchestra BioMed [1][2]. Group 1: Financial Expectations - Orchestra BioMed expects to receive $11 million in proceeds during 2026, consisting of approximately $5 million upfront and about $6 million as a first milestone payment, with the remainder to be earned based on future revenue milestones [2][5]. - The total expected proceeds from the acquisition amount to $21 million, indicating a significant financial benefit for Orchestra BioMed [1]. Group 2: Product and Technology Overview - Vivasure's PerQseal® Elite system utilizes a proprietary bioabsorbable patch for sealing large-bore arteriotomies and venotomies, providing a sutureless and fully absorbable solution for various medical procedures [3]. - The PerQseal Elite system has received CE Mark approval in Europe and a Premarket Approval application has been submitted to the U.S. FDA, showcasing its regulatory progress and market potential [3]. Group 3: Strategic Partnerships and Development - Orchestra BioMed has been a strategic partner of Vivasure since its inception, actively supporting the development of the PerQseal technology [3][4]. - The collaboration with Haemonetics is expected to enhance the commercial prospects of the PerQseal Elite system, leveraging Haemonetics' market presence in the large-bore closure market [3][7]. Group 4: Company Background - Orchestra BioMed is focused on accelerating high-impact biomedical technologies through strategic collaborations, with flagship products like AVIM Therapy and Virtue® Sirolimus AngioInfusion™ Balloon undergoing pivotal clinical trials [4][6]. - The company aims to address significant health issues, such as hypertension and atherosclerotic artery disease, which represent multi-billion-dollar market opportunities [4][6].

Core Insights - Orchestra BioMed Holdings, Inc. reported strong financial results for Q3 2025, securing nearly $150 million in capital to advance its pivotal-stage programs [3][4][5] - The company is actively enrolling patients in the Virtue Trial, which compares its Virtue® Sirolimus AngioInfusion™ Balloon to commercially available options [3][4] - The company has expanded its strategic collaborations with Medtronic and Terumo, enhancing its business model and financial position [3][4][5] Financial Highlights - Cash and cash equivalents and marketable securities totaled $95.8 million as of September 30, 2025, with a cash runway extended into Q4 2027 [10] - Revenue for Q3 2025 was $0.9 million, a slight decrease from $1.0 million in Q3 2024 [10] - The net loss for Q3 2025 was $20.8 million, or $0.40 per share, compared to a net loss of $15.4 million, or $0.41 per share, in Q3 2024 [10][19] Strategic Partnerships - The company secured $71.6 million in committed capital from Medtronic and Ligand, along with $30 million from Terumo, which includes a right of first refusal agreement [3][4] - The collaboration with Medtronic aims to develop AVIM Therapy-enabled leadless pacemakers, while the agreement with Terumo provides strategic options for the Virtue SAB [4][5] Clinical Development - The BACKBEAT study is expected to complete enrollment by mid-2026, while the Virtue Trial aims for completion by mid-2027 [4][5] - AVIM Therapy has received FDA Breakthrough Device Designation for treating uncontrolled hypertension, targeting a significant patient population in the U.S. [7][11] - Virtue SAB is designed to deliver a proprietary sirolimus formulation and has also received FDA Breakthrough Device Designation for multiple indications [12]

Core Insights - Orchestra BioMed Holdings, Inc. is set to host a business update call on November 12, 2025, focusing on significant clinical, strategic, and financing developments [1][2] Company Developments - The update will cover a strategic investment and collaboration expansion with Medtronic, a new capital relationship with Ligand, and a right of first refusal agreement with Terumo [2] - Enrollment in the BACKBEAT pivotal study of AVIM Therapy is accelerating, and patient enrollment has begun in the Virtue SAB US pivotal IDE coronary trial [2] Product Information - Orchestra BioMed's flagship products include Atrioventricular Interval Modulation (AVIM) Therapy and Virtue® Sirolimus AngioInfusion™ Balloon (Virtue SAB), both undergoing pivotal clinical trials [3] - AVIM Therapy targets uncontrolled hypertension and has FDA Breakthrough Device Designation, with an estimated 7.7 million patients in the U.S. affected [3] - Virtue SAB is a drug delivery angioplasty balloon system designed for treating atherosclerotic artery disease and has also received FDA Breakthrough Device Designation [3]

Core Insights - Orchestra BioMed has entered into a termination and right of first refusal agreement with Terumo Corporation regarding the Virtue® Sirolimus AngioInfusion™ Balloon for coronary artery disease treatment, with Terumo making an upfront payment of $10 million [1] - Terumo will invest an additional $20 million in Orchestra BioMed through a new series of non-voting preferred stock, convertible into common stock at a minimum of $12 per share [1] - The new agreements highlight the clinical and commercial potential of Virtue SAB, which is positioned to become a leading therapy in the global coronary market [2] Agreement Details - The ROFR Agreement allows Orchestra BioMed to seek development and commercialization partnerships for Virtue SAB in any therapeutic indication, while Terumo has the first right to respond to third-party offers related to the global coronary market [3] - The ROFR period lasts for 90 days after the disclosure of primary endpoint data from the Virtue Trial [3] - The transactions are expected to close by November 7, 2025, subject to customary closing conditions [4] Company Overview - Orchestra BioMed focuses on accelerating high-impact biomedical technologies through strategic collaborations, with flagship products including AVIM Therapy and Virtue SAB, both targeting multi-billion-dollar global market opportunities [5] - Virtue SAB is a first-of-its-kind drug delivery angioplasty balloon system designed to deliver an extended-release formulation of sirolimus, showing positive clinical data in treating coronary in-stent restenosis [8] - The company has received FDA Breakthrough Device Designation for Virtue SAB for multiple indications, including coronary ISR and small vessel disease [7][8] Market Context - Coronary in-stent restenosis (ISR) is a significant complication affecting up to 10% of stented patients in the first year, leading to over 325,000 lesions annually that may require treatment [9] - Current FDA-approved treatments for coronary ISR are limited, with traditional balloon angioplasty having high retreatment rates, indicating a need for innovative solutions like Virtue SAB [9]