Press Release (ePRNews.com) - Aug 02, 2025 - Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO), a New Hope, Pennsylvania-based biomedical innovation company, announced on August 1, 2025, that it has secured $70 million in new capital from Ligand Pharmaceuticals (Nasdaq: LGND) and Medtronic (NYSE: MDT). This funding will accelerate the development and commercialization of its late-stage cardiovascular programs, including AVIM therapy for hypertension and Virtue® Sirolimus AngioInfusion™ Balloon (SAB) for atherosclerotic artery disease. With a partnership-driven model, Orchestra collaborates with industry leaders like Medtronic and Terumo to drive global market access, supported by four FDA Breakthrough Device Designations. The company’s total funding exceeds $285 million, reinforcing its mission to address critical cardiovascular needs.
The $70 million capital raise, comprising investments from Ligand Pharmaceuticals and Medtronic, builds on Orchestra’s prior financings, including a $110 million Series D in 2022 and a $34 million Series B-1 in 2019. The funds will support clinical trials, partnership expansion, and pipeline development. Orchestra also has access to a $40 million term debt facility from Avenue Venture Opportunities Fund, ensuring a cash runway into 2026. This latest round reflects strong investor confidence in Orchestra’s innovative therapies and partnership-enabled business model.
| Funding Round | Amount | Year | Lead Investors | Supporting Investors |
|---|---|---|---|---|
| Series B-1 | $34M | 2019 | Perceptive Advisors, RTW Investments, Soleus Capital | Terumo, SternAegis Ventures |
| Series D | $110M | 2022 | Medtronic, RTW Investments | Perceptive Advisors, Terumo, SternAegis Ventures |
| Latest Round | $70M | 2025 | Ligand Pharmaceuticals, Medtronic | – |
| Total Raised | $285M+ | – | – | – |
Core Programs
Orchestra BioMed’s flagship programs address two leading causes of mortality worldwide:
- AVIM Therapy (AtrioVentricular Interval Modulation): A novel cardiac neuromodulation therapy integrated with standard pacemakers to reduce blood pressure in patients with uncontrolled hypertension. Partnered with Medtronic, AVIM has two FDA Breakthrough Device Designations and is in late-stage clinical trials targeting pacemaker-indicated patients.
- Virtue SAB: A drug-eluting balloon that delivers sirolimus to treat atherosclerotic artery disease, including coronary in-stent restenosis and peripheral artery disease. Partnered with Terumo, Virtue SAB has two FDA Breakthrough Device Designations and is advancing through trials in the U.S., Japan, and other markets.
These programs leverage Orchestra’s partnership model, where development risks are shared with industry leaders, ensuring efficient commercialization and alignment with clinical workflows.
Leadership and Expertise
Orchestra BioMed is led by CEO David Hochman and President/COO Darren Sherman, both with over 25 years of experience in healthcare and medical devices. Hochman, a co-founder, previously led Orchestra Medical Ventures, while Sherman served as Chief Technical Officer at Accelerated Technologies, Inc. The team includes advisors like Dr. Steven Evans, a cardiovascular electrophysiology expert, and John Cleary, a former Medtronic executive with extensive M&A experience. This leadership drives Orchestra’s focus on data-driven, high-impact solutions.
Industry Impact and Challenges
Cardiovascular diseases, including hypertension and artery disease, cause 17.9 million deaths annually, per the World Health Organization. Orchestra’s AVIM therapy targets resistant hypertension, affecting millions with limited treatment options, while Virtue SAB offers a non-stent alternative for artery disease, improving outcomes without permanent implants. Partnerships with Medtronic and Terumo enhance global scalability, with clinical trials targeting approvals by 2026.
Challenges include navigating FDA and international regulatory pathways and managing clinical trial risks. Orchestra mitigates these through its FDA designations, rigorous trial data, and partnerships that leverage established infrastructure. Competition from companies like Boston Scientific and Abbott is notable, but Orchestra’s niche focus and collaborative model provide a competitive edge.
Stakeholder Perspectives
David Hochman stated, “This $70 million investment from Ligand and Medtronic validates our partnership-enabled approach and accelerates our mission to deliver transformative cardiovascular solutions. Our collaborations allow us to focus on innovation while leveraging the commercial strength of industry leaders.” Medtronic’s continued investment underscores the strategic alignment, with potential for expanded indications in future trials.
Future Outlook
With over $285 million in funding and a cash runway into 2026, Orchestra BioMed is poised to complete pivotal trials for AVIM therapy and Virtue SAB. The company aims to expand Virtue SAB’s indications to small coronary vessels and below-the-knee peripheral artery disease, broadening its market potential. Regulatory approvals in key markets, supported by partnerships, could position Orchestra as a leader in cardiovascular innovation by 2027.
Source : Orchestra BioMed Holdings, Inc.
