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]

Core Insights - Orchestra BioMed has initiated the first patient enrollments in the Virtue Trial, a pivotal U.S. IDE trial comparing its Virtue® Sirolimus AngioInfusion Balloon (Virtue SAB) to the AGENT paclitaxel-coated balloon, the only FDA-approved drug-coated balloon for coronary indications [1][5] - The Virtue Trial aims to enroll 740 patients across up to 75 centers in the U.S., with completion expected by mid-2027 [1][5] - Virtue SAB is designed to optimize the delivery and extended release of sirolimus, addressing limitations of traditional drug-coated balloons [2][8] Company Overview - Orchestra BioMed is focused on accelerating high-impact biomedical technologies through strategic partnerships with leading global medical device companies [9] - The company’s flagship products include the Virtue SAB and Atrioventricular Interval Modulation (AVIM) Therapy, both of which are undergoing pivotal clinical trials and represent significant market opportunities [9] - Virtue SAB has received FDA Breakthrough Device Designation for treating coronary in-stent restenosis (ISR), coronary small vessel disease, and below-the-knee peripheral artery disease [3][9] Product Details - Virtue SAB is the first non-coated drug-eluting balloon system designed to deliver a large liquid dose of proprietary extended-release sirolimus (SirolimusEFR) [3][8] - The device aims to enhance tissue uptake and drug bioavailability, surpassing previously published target tissue concentrations of drug-eluting stents [2][8] - Clinical data from the SABRE pilot study indicated promising results for Virtue SAB in treating single-layer coronary ISR [8] Market Context - The global market opportunity for drug-eluting balloons is estimated to exceed $10 billion annually [5] - Coronary ISR affects approximately 100,000 patients in the U.S. each year, representing a significant clinical challenge [3][7] - The Virtue Trial's primary endpoint is a non-inferiority comparison of Target Lesion Failure (TLF) at 12 months, which includes cardiac death, nonfatal myocardial infarction, and ischemia-driven target lesion revascularization [5]

Core Insights - Orchestra BioMed is presenting data on Atrioventricular Interval Modulation (AVIM) Therapy, highlighting its potential to transform the management of hypertensive heart disease at the Georgia Innovation Summit on October 10, 2025 [1][2] - AVIM Therapy is recognized as a novel, device-based approach that could redefine standards of care for hypertension, which is a major contributor to heart failure [2][4] Company Overview - Orchestra BioMed is a biomedical innovation company focused on accelerating high-impact technologies through strategic partnerships with leading medical device companies [3] - The company's primary product candidate is AVIM Therapy, aimed at treating hypertension, the leading risk factor for mortality globally [3][6] AVIM Therapy Details - AVIM Therapy is designed to work with standard dual-chamber pacemakers to significantly lower blood pressure and has shown promising results in pilot studies [8] - The MODERATO I and II pilot studies demonstrated substantial reductions in 24-hour ambulatory systolic blood pressure, with reductions of 11.6 mmHg and 15.6 mmHg at one day, respectively [5] - Long-term follow-up indicates sustained blood pressure reduction and improvements in cardiac function, with no significant adverse effects on heart metrics [5][8] Strategic Collaborations - Orchestra BioMed has a strategic partnership with Medtronic to develop and commercialize AVIM Therapy for patients with uncontrolled hypertension who are indicated for a pacemaker, targeting an estimated global population of over 750,000 patients annually [4][6] - The therapy has received FDA Breakthrough Device Designation for treating uncontrolled hypertension in patients at increased cardiovascular risk, representing a U.S. population of over 7.7 million patients [4][8]