Orchestra BioMed Holdings, Inc.

Orchestra BioMed Holdings, Inc. is a biomedical innovation company that accelerates high-impact medical technologies to patients through strategic collaborations with market-leading global medical device companies. The company was formed in 2018 and is led by a multidisciplinary management team and board of directors with extensive experience in therapeutic device development. Orchestra BioMed's flagship product candidates are Atrioventricular Interval Modulation Therapy ("AVIM Therapy") for hypertension ("HTN") and Virtue® Sirolimus AngioInfusion™ Balloon ("Virtue SAB") for atherosclerotic artery disease. HTN is the leading risk factor for death worldwide, and atherosclerotic artery disease is the leading cause of mortality worldwide. The company has an exclusive license and collaboration agreement with Medtronic, Inc. for the development and commercialization of AVIM Therapy. Orchestra BioMed is currently conducting the "BACKBEAT study," a double-blind, randomized, global pivotal study enrolling up to 500 patients with uncontrolled hypertension who are indicated for a Medtronic dual-chamber pacemaker. Enrollment completion for the BACKBEAT study is currently planned for mid-2026. Orchestra BioMed recently initiated patient enrollments in the "Virtue Trial" for its U.S. investigational device exemption ("IDE") pivotal study. This trial randomizes Virtue SAB against Boston Scientific Corporation's AGENT™ drug-coated balloon for the treatment of coronary in-stent restenosis ("ISR"). The Virtue Trial is designed to support regulatory approval of Virtue SAB and is expected to enroll 740 patients in the United States, with enrollment completion currently planned for mid-2027. AVIM Therapy is a bioelectronic therapy candidate designed to lower blood pressure and can be integrated as a firmware upgrade to standard cardiac pacemakers. HTN affects over 70% of pacemaker-indicated patients, making AVIM Therapy a potentially attractive therapeutic solution for this population.