Orchestra BioMed (OBIO) TD Cowen 46th Annual Health Care Conference summary

Business model and partnerships

• Focus on innovation through partnerships, applying a biotech-style model to medtech.

• Key partnerships with Medtronic, Ligand, and Terumo drive commercialization and provide significant capital.

• Well-capitalized with funding secured through late 2027, including recent asset sales and milestone payments.

• Royalty-based revenue model with substantial per-device royalties from Medtronic for AVIM therapy.

• Terumo holds a right of first refusal for Virtue SAB, providing strategic optionality.

Clinical programs and market opportunities

• Two pivotal trials actively enrolling: AVIM therapy for hypertension and Virtue SAB for coronary artery disease.

• AVIM therapy targets hypertensive heart disease in pacemaker patients, representing a $15–17 billion annual global opportunity.

• Virtue SAB is a first-of-its-kind non-coated sirolimus angioinfusion balloon, addressing a $10 billion+ annual market.

• Both programs have received multiple FDA Breakthrough Designations.

• BACKBEAT pivotal trial for AVIM therapy aims for data readout by 2028, with Virtue SAB pivotal trial enrollment targeted for completion in 2027.

AVIM therapy: Mechanism, data, and impact

• AVIM therapy uses pacemaker-based atrioventricular interval modulation to immediately and persistently lower systolic blood pressure.

• Demonstrated double-digit reductions in systolic blood pressure, with sustained effects and no major adverse events in pilot studies.

• Particularly effective in older, high-risk patients with isolated systolic hypertension and diastolic dysfunction.

• Partnership with Medtronic includes integration into next-generation devices and potential expansion to leadless devices.

• Potential to become standard of care for pacemaker patients and expand to broader hypertensive populations.