Orchestra BioMed Secures $111 Million in Financing, Expands Partnerships with Medtronic and Ligand

Orchestra BioMed, a medical technology company, has successfully raised over $111 million through a series of transactions and offerings, bolstering its position to advance late-stage clinical studies for its innovative cardiovascular therapies. The financing round, supported by strategic partnerships with industry giants Medtronic and Ligand Pharmaceuticals, underscores growing interest in Orchestra's pioneering approaches to treating high blood pressure and coronary artery disease.

Financing Breakdown and Strategic Partnerships

The $111 million financing package comprises several components:

• A $40 million public offering
• Approximately $16 million in private placements of common stock to Medtronic and Ligand
• A $20 million commitment from Medtronic, due by May 2026, in exchange for a promissory note convertible to a prepaid revenue share
• A $35 million commitment from Ligand for tiered revenue interest in future royalties

Medtronic, a global leader in medical technology, has expanded its existing collaboration with Orchestra BioMed. The partnership now includes a pathway for developing AVIM-capable leadless pacemakers, in addition to their previous exclusive license agreement for the BackBeat therapy.

Ligand Pharmaceuticals, an established royalty investor, has joined as a strategic capital partner. Their investment is tied to both the BackBeat therapy and the Virtue sirolimus-equipped balloon program.

Advancing Innovative Cardiovascular Therapies

The newly secured funds will primarily support two key clinical programs:

BackBeat Therapy for Hypertension

Orchestra's BackBeat neuromodulation therapy, designed to integrate with existing cardiac rhythm implants, has shown promising results in early studies. In a trial involving 14 patients, the therapy demonstrated a 10.3 mmHg reduction in 24-hour systolic blood pressure after six months.

The financing will fund the full enrollment of a global pivotal trial for BackBeat's atrioventricular interval modulation (AVIM) approach, as well as support follow-up measures to evaluate primary endpoints.

Virtue Sirolimus-Equipped Balloon for Coronary Artery Disease

The Virtue angioplasty therapy, developed in partnership with Terumo Corporation since 2019, delivers a precise dose of sirolimus through micropores in the balloon. This approach differs from traditional drug-coated balloons by avoiding an outer drug coating.

The new funding will help complete enrollment in a trial focused on treating in-stent restenosis of the coronary arteries.

Industry Implications and Future Outlook

Orchestra BioMed's successful financing round and expanded partnerships highlight the pharmaceutical industry's growing interest in innovative medical technologies that address significant cardiovascular health challenges. The company's CEO, David Hochman, expressed confidence that these developments position Orchestra to advance their core technologies towards crucial clinical and regulatory milestones.

As the company progresses with its late-stage clinical studies, the outcomes of these trials could have far-reaching implications for the treatment of hypertension and coronary artery disease. The potential integration of AVIM technology into leadless pacemakers, in particular, represents a significant step forward in the field of cardiac rhythm management.