Company Profile
Orchestra BioMed Holdings, Inc. is a US-based biomedical innovator of bioelectronic and interventional cardiovascular therapies, headquartered in New Hope, Pennsylvania, USA. Founded in 2017 by David P. Hochman and Darren R. Sherman, the company operates as a publicly listed entity on Nasdaq (OBIO) with 86 employees, serving global cardiovascular markets through strategic risk-reward sharing partnerships with Medtronic plc and Terumo Corporation.
Core Products ＆ Technologies
Bioelectronic Therapy
• AVIM Therapy (Atrioventricular Interval Modulation): Investigational bioelectronic therapy delivered as a firmware upgrade to standard dual-chamber pacemakers to substantially and persistently lower blood pressure in hypertensive heart disease patients
• CNT-HF (Cardiac Neuromodulation Therapy for Heart Failure): Preclinical bioelectronic candidate designed to reduce chronic sympathetic nervous system activity in heart failure
Interventional Drug Delivery
• Virtue Sirolimus AngioInfusion Balloon (Virtue SAB): First-of-its-kind non-coated microporous angioplasty balloon system delivering proprietary extended-release sirolimus formulation (SirolimusEFR™) for atherosclerotic artery disease
• BACKBEAT Global Pivotal Study: Ongoing trial evaluating AVIM Therapy safety and efficacy in pacemaker-indicated patients with uncontrolled hypertension; target enrollment completion mid-2026
• Virtue Trial (US IDE Pivotal): Ongoing 740-patient, 75-site US pivotal trial comparing Virtue SAB to paclitaxel-coated balloon for coronary in-stent restenosis; target enrollment completion mid-2027
Market Position ＆ Certifications
Orchestra BioMed holds an emerging leadership position in the partnership-driven cardiovascular therapy space, competing with Boston Scientific (Agent paclitaxel-coated balloon) in coronary ISR and developing novel bioelectronic alternatives to pharmacologic hypertension management. Key strengths include:
• 9 years of US biomedical innovation heritage
• Dual breakthrough designations: FDA Breakthrough Device Designation for AVIM Therapy (uncontrolled hypertension, April 2026) and Virtue SAB (coronary ISR, coronary small vessel disease, below-the-knee PAD)
• Strategic partnerships: AVIM co-development with Medtronic; Virtue SAB coronary ROFR and $30M strategic agreement with Terumo
• Clinical evidence: MODERATO II showed immediate 13.2 mmHg oSBP reduction and 97% patient response rate; sustained 8.1 mmHg 24-hour aSBP reduction at 6 months
• Strong balance sheet: $106.5M cash as of December 2025, further enhanced by $35M received from Medtronic and Ligand in May 2026
Corporate Timeline
2017 — Founded in New Hope, Pennsylvania, USA
2022 — Completed SPAC merger and began trading on Nasdaq (OBIO)
2023 — Reported positive MODERATO II six-month data for AVIM Therapy
2024 — Received FDA IDE approval for Virtue SAB coronary ISR pivotal trial
2025 — Enrolled first patients in Virtue Trial (October); entered new $30M ROFR agreement with Terumo (October); secured nearly $150M in total capital and committed capital
2026 — FDA granted second Breakthrough Device Designation for AVIM Therapy (April); received $35M strategic capital from Medtronic ($20M) and Ligand ($15M) (May); target completion of BACKBEAT enrollment mid-2026
Target Markets ＆ Applications
• Uncontrolled Hypertension: AVIM Therapy for pacemaker-indicated patients with systolic BP above target despite medication, addressing an estimated 7.7 million US adults
• Coronary In-Stent Restenosis: Virtue SAB for coronary ISR lesions occurring in up to 10% of stented patients annually
• Peripheral Artery Disease: Virtue SAB for below-the-knee arterial disease via non-coated sirolimus delivery
Contact Information
Global Headquarters
Address: 150 Union Square Drive, New Hope, PA 18938, USA
Corporate Status
Entity Type: Publicly Listed Company (No Parent Company)
Stock: Nasdaq: OBIO
Website: orchestrabiomed.com
Investor Relations: investors.orchestrabiomed.com
