OBIO | Virtue SAB IDE Approval and What It Means for OBIO Shareholders

Fellow Shareholders

Today, Orchestra BioMed announced a major advancement for its proprietary Virtue® Sirolimus AngioInfusion Balloon™ (Virtue SAB), with the FDA granting approval of the company’s amended Investigational Device Exemption (IDE) to initiate a pivotal U.S. clinical trial designed to evaluate Virtue SAB head-to-head against the AGENT™ paclitaxel-coated balloon, the only drug-coated balloon (DCB) currently FDA-approved for coronary use.

Virtue SAB stands apart as the only non-coated drug-eluting balloon system delivering a large liquid dose of proprietary extended-release sirolimus — a key differentiator with potential to set a new standard in interventional cardiology.

What does this mean for OBIO shareholders?

CEO David Hochman captures the essence of the news in his press release quote:

“We believe there is a multibillion-dollar U.S. market for coronary drug delivery balloons based on the significant unmet clinical need, market demand, and established reimbursement. We made a deliberate, strategic decision to pursue a head-to-head trial with the commercially available AGENT paclitaxel-coated balloon, underscoring our confidence in Virtue SAB as a fundamentally differentiated solution for the treatment of atherosclerosis. We believe this approach offers the most direct path to regulatory approval while also providing the best opportunity to demonstrate what we believe are distinctive and sustainable advantages of our proprietary technology.”

Beyond this perspective, it’s important for investors also to note that key sector opinion leaders are leading the trial: Dr. Dean Kereiakes and Dr. Allen Jeremias. Both physicians are highly respected interventional cardiology leaders whose oversight reinforces clinical credibility and future adoption.

“Virtue SAB has the potential to be one of the most compelling technologies in interventional cardiology. It’s the only product in development that optimizes both the arterial tissue uptake and retention of sirolimus to achieve pharmacokinetics that match or even exceed those of proven ‘limus-eluting stents.”

• Dean J. Kereiakes, M.D.

“In a field largely reliant on paclitaxel drug-coated balloons, Virtue SAB stands out as the only device with a completely different mechanism of action; namely to provide delivery of a large liquid dose of an extended-release formulation sirolimus.”

• Allen Jeremias, M.D.

Specifically, we’d highlight four value drivers associated with this milestone:

1. Major U.S. Regulatory Catalyst

FDA approval of the IDE clears OBIO to initiate a robust non-inferiority trial designed to enroll 740 patients, provide a clear pathway to regulatory approval, and showcase the potential clinical advantages of Virtue SAB.

2. Head-to-Head Against the Market Leader

The Virtue Trial will be the first U.S. head-to-head randomized evaluation of a sirolimus-eluting balloon versus a paclitaxel-coated balloon for the treatment of coronary artery disease.

3. Multi-Billion Dollar Market Opportunity

With significant unmet clinical needs in atherosclerotic disease and established reimbursement pathways, we believe the commercial opportunity for Virtue SAB is large, timely, and highly compelling.

4. Strong Foundation from Breakthrough Device Designation

Virtue SAB has already received FDA Breakthrough Device Designation in key coronary and peripheral artery disease indications — reinforcing its innovation and helping enable a potentially accelerated path to market.

We are currently targeting to initiate the Virtue Trial in the second half of 2025. With a rigorous trial design, strategic head-to-head positioning, and a differentiated drug delivery platform, we believe Virtue SAB represents one of the most exciting device opportunities in cardiovascular medicine.

Here, as with our AVIM therapy program and global pivotal study, we remain focused on execution. Our mission is to bring new clinical solutions to millions of patients in need.

Orchestra is just warming up. Stay tuned!

—Team OBIO