Orchestra BioMed Secures Funding, Shifts Strategy to Advance Novel Cardiovascular Therapies

NEWTOWN SQUARE, PA – November 10, 2024 – Orchestra BioMed, a medical device company pioneering bioelectronic therapies and targeted drug delivery for cardiovascular disease, today announced a strategic realignment of its partnerships and significant progress in its clinical development programs. The company is bolstering its financial position and refocusing its efforts on its lead candidates: AVIM Therapy for resistant hypertension and Virtue SAB, a sirolimus-eluting drug-coated balloon for coronary artery disease.

Orchestra BioMed recently secured a combination of funding through private investment and strategic partnership adjustments, including a deepened collaboration with Medtronic and a revised agreement with Terumo. These moves allow the company to retain full control over the development and commercialization of Virtue SAB while accelerating the clinical trials for AVIM Therapy.

Navigating Strategic Partnerships

Orchestra BioMed has strategically adjusted its alliances to position itself for long-term success. The company expanded its existing relationship with Medtronic, focusing on the integration of AVIM Therapy with a dual-chamber leadless pacemaker. This collaboration leverages Medtronic’s expertise in implantable devices and could significantly broaden the potential applications and market reach of AVIM Therapy.

“The expanded collaboration with Medtronic is a testament to the potential of AVIM Therapy and provides a clear path toward future integration with a leading pacemaker platform,” stated an anonymous company insider. “This collaboration is not just financial; it's a validation of our technology and a strategic move to accelerate its adoption.”

In a surprising move, Orchestra BioMed terminated its prior agreement with Terumo for the development and commercialization of Virtue SAB. However, the company simultaneously secured $30 million from Terumo, including a $10 million payment for a Right of First Refusal on the product and a $20 million payment for the sale of Terumo Preferred Stock. This restructuring gives Orchestra BioMed full control over the development and commercialization of the novel drug-coated balloon.

“Taking full control of Virtue SAB allows us to optimize its development and maximize its potential value,” said another anonymous source familiar with the company’s strategy. “We believe this will allow us to move more quickly and efficiently, and to tailor our approach to the specific needs of the market.”

AVIM Therapy: Disrupting Hypertension Treatment

AVIM Therapy, an investigational bioelectronic treatment, aims to provide a non-pharmacological approach to resistant hypertension. The therapy modulates autonomic nervous system responses to deliver a sustained reduction in blood pressure. The company is currently enrolling patients in the BACKBEAT global pivotal study, with enrollment targeted for completion in 2026.

“Traditional hypertension treatments often require patients to take multiple medications, which can lead to side effects and reduced quality of life,” explained an independent cardiology expert. “A device-based therapy like AVIM, which addresses the underlying neural mechanisms of hypertension, could offer a valuable alternative for patients who are not responding to conventional treatments.”

The potential for integration with a Medtronic pacemaker further enhances AVIM's appeal. Combining the therapy with a pacemaker could provide a more comprehensive and personalized approach to hypertension management. The company views this as a significant differentiator in a crowded market.

Virtue SAB: A Novel Approach to Coronary Intervention

Virtue SAB is a drug-coated balloon designed to deliver a sustained release of sirolimus directly to the site of coronary artery blockage. Unlike traditional drug-eluting stents, Virtue SAB does not require a permanent implant, potentially reducing the risk of late-stage complications.

The device is currently undergoing clinical trials, with the company anticipating robust data demonstrating its efficacy and safety. The sirolimus-eluting technology is seen as a potential advantage over paclitaxel-based drug-coated balloons, which have faced some safety concerns in recent years.

“There's a growing interest in sirolimus-based therapies for coronary artery disease,” said another cardiology specialist. “Sirolimus has a well-established safety profile and a proven anti-proliferative effect. A drug-coated balloon that delivers sirolimus directly to the lesion could offer a compelling alternative to traditional stents.”

Competitive Landscape and Future Outlook

Orchestra BioMed faces competition from established players in both the hypertension and coronary artery disease markets. In the hypertension space, the company competes with pharmaceutical companies offering medication and device companies developing renal denervation therapies. In the coronary intervention market, the company competes with manufacturers of drug-eluting stents and other drug-coated balloons.

However, Orchestra BioMed believes its innovative technologies and strategic partnerships position it for success. The company is committed to advancing its clinical development programs and bringing its therapies to market. The company’s recent strategic adjustments and funding injections signal a clear commitment to long-term growth and innovation. Analysts predict significant potential for both AVIM Therapy and Virtue SAB if clinical trials continue to deliver positive results. The company expects to have preliminary data from its key trials available in late 2025, potentially driving further investment and partnerships.

Orchestra BioMed’s leadership believes the company is on the cusp of transforming cardiovascular care. The company’s commitment to innovation and its strategic partnerships are poised to deliver meaningful benefits to patients worldwide.