NEW HOPE, PA — Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO) has announced its financial results for 2024, alongside major updates on its clinical programs and corporate strategy. The company has demonstrated progress in its global pivotal study for atrioventricular interval modulation (AVIM) therapy and its Virtue Sirolimus AngioInfusion Balloon (SAB) program, while addressing strategic partnerships and enhancing leadership to strengthen operations.
Progress in Clinical Programs
At the forefront of Orchestra BioMed’s efforts is the BACKBEAT global pivotal study, conducted in collaboration with Medtronic (NYSE: MDT). This study evaluates the efficacy and safety of AVIM therapy as a treatment for uncontrolled hypertension in pacemaker patients. By modulating intervals to lower blood pressure and enhance diastolic function, AVIM therapy has the potential to redefine the standard of care for such patients. “We believe this therapy can lead to landmark results and lay the foundation for its use in managing blood pressure and cardiovascular health in high-risk populations,” said David Hochman, Chairman, CEO, and Founder of Orchestra BioMed.
Additionally, the company is advancing its Virtue SAB program. A revised study design for the U.S. coronary pivotal study on in-stent restenosis (ISR) has been submitted to the FDA. This study will compare the Virtue SAB, which delivers extended focal-release sirolimus without a balloon coating, to Boston Scientific’s AGENT drug-coated balloon for ISR treatment. FDA approval of the amended investigational device exemption (IDE) is expected in the second quarter of 2025, with study initiation targeted for the second half of the year.
Addressing Strategic Partnerships
Orchestra BioMed is currently restructuring its partnership with Terumo. To expedite this process, both parties have agreed to enter formal mediation, with a resolution anticipated by the second quarter of 2025. The outcome of these discussions is expected to align with the anticipated launch of the Virtue ISR-US pivotal study later this year.
Leadership Enhancements
The company has reinforced its leadership with new appointments to its board of directors. Christopher Cleary, former Senior Vice President at Medtronic, John Mack, former President of Cardiac Surgery at Medtronic, and David Pacitti, CEO of Avanos Medical, bring deep expertise in the medical device and cardiovascular sectors. Additionally, Mark Pomeranz has joined as Executive Vice President & General Manager, Interventional Therapies. Pomeranz has over two decades of experience in medical device innovation, further bolstering Orchestra BioMed’s senior management team.
Key Financial Highlights
- Revenue for 2024 was $2.6 million, a slight decline from $2.8 million in 2023, attributed to reduced recognition of partnership revenues.
- R&D Expenses increased to $42.8 million from $33.8 million in 2023, reflecting higher costs tied to the BACKBEAT pivotal study.
- Net Loss for the year was $61.0 million, or $1.66 per share, compared to $49.1 million, or $1.48 per share, in 2023. The net loss included $10.6 million in non-cash stock-based compensation expenses.
- Cash and Cash Equivalents totaled $66.8 million as of December 31, 2024, supported by $15.0 million raised through stock sales and $15.0 million drawn from a credit facility.
Looking Ahead
Orchestra BioMed remains committed to advancing its core programs. Upcoming milestones include securing FDA approval for the IDE for the Virtue SAB pivotal study in the second quarter of 2025 and completing site activations for the BACKBEAT study. The company continues to focus on clinical innovation, operational efficiency, and strategic partnerships to address significant unmet needs in cardiovascular care.
By combining breakthrough technologies with skilled leadership, Orchestra BioMed is well-positioned to drive meaningful advances in cardiovascular therapy. Its commitment to transforming care for patients with hypertension and ISR underscores its role as a leader in medical innovation.
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