AVIM Therapy Patent Portfolio Reaches New Milestone

OBIO | AVIM Patent Portfolio Reaches New Milestone

Fellow Shareholders:

This week, Orchestra BioMed announced that its global intellectual property (IP) estate for AVIM™ therapy has reached 137 issued patents, reinforcing the company’s dominant IP protection for its unique device-based treatment for hypertension and heart failure.

This announcement reflects a year of focused execution, during which OBIO secured 10 new patents related to hypertension and unveiled a 17-patent portfolio covering heart failure applications.

In total, OBIO’s AVIM Therapy issued patent portfolio comprises over 2,100 individual proprietary claims.

We’ve summarized the key evolution of our hypertension IP portfolio since last April’s announcement in the chart below:

"Building a Global Hypertension IP Fortress: AVIM Patent Growth Year-over-Year"

Together, these milestones underscore OBIO’s continued strategic commitment to building the long-term value of this FDA Breakthrough Designation Device therapy for which it has a strategic collaboration with Medtronic. Here are what we see as the key value drivers behind today’s announcement:

1. Reinforced Global Exclusivity

   OBIO’s intellectual property spans key geographies, including the U.S., Europe, Japan, and China, providing a strong foundation for future commercialization and strategic partnerships.

2. New Strategic Footing in Heart Failure, Highlighting a Market Expansion

   OBIO’s also disclosed that it has secured a total of 17 issued patents protecting AVIM therapy for the treatment of heart failure — a global disease affecting over 64 million people. This significantly expands OBIO’s clinical footprint and future market potential.

3. Broader FDA Recognition of AVIM’s Potential

   The FDA recently granted Breakthrough Device Designation to AVIM therapy for a broad patient population that has uncontrolled hypertension and increased cardiovascular risk. This reflects growing regulatory validation of AVIM’s potential.

   OBIO’s mission is to bring high-impact medical innovations to patients with serious unmet needs. With a deepening IP moat, breakthrough designation status, and a pivotal global trial underway, we believe AVIM therapy continues to represent one of the most promising device-based approaches in cardiovascular medicine today.

We look forward to sharing more as our momentum continues to build.

Orchestra is just warming up. Stay tuned!

— Team OBIO