For Forward Looking Statements: https://bit.ly/4nHgE6t

Fellow Shareholders:

On July 1st, Orchestra BioMed Chairman and CEO David Hochman appeared on the floor of the New York Stock Exchange to discuss the company's business model, product development and impact on high-need patient populations worldwide. S

You can watch the full 10-minute interview here: Orchestra BioMed: Partnering with Medtronic to Tackle Global Hypertension | NYSE.

While it’s well worth a review by every shareholder, investors may find immediate value in listening to the Chairman and CEO’s remarks on three topics:

1. Partnership model adapted from pharma to medtech
2. AVIM therapy is novel, always-on blood pressure treatment that is designed to be delivered as a firmware enhancement to a standard pacemaker
3. FDA Breakthrough status reinforces broader market opportunity for AVIM therapy

Below is a summary of David’s remarks on each topic- as well as timestamps for quick access to high-impact points.

Deeper Dive: What We Said and Why It Matters

1.  Partnership Model Adapted from Pharma to Medtech | Timestamp: 1:46–2:31
   
   Key Quote:
   “We were inspired by the kind of strategic partnerships that we hear about all the time in the pharma industry… Why can’t we bring this to the medical device space?”

In the interview, David describes OBIO’s business model as one adapted from what the pharmaceutical sector has proven to be effective: rather than consolidating development costs, risks, expertise and commercialization all under one balance sheet, create partnerships that advantage both parties, allowing each partner to dedicate itself to what it does best and where it has the best-in-class capabilities.

In medtech, large companies often lack the P&L and operating capacity to advance novel, development-stage devices internally. The top 20 medtech companies spend an average of approximately 7% of revenue on research & development annually. As a result, revenue growth through innovation is constrained by their ability to spend money on R&D or absorb the R&D expenses of pre-commercial assets they might want to acquire. OBIO’s business model allows collaborator companies to outsource the work and the P&L expense of R&D, positioning OBIO as an engine to facilitate growth while protecting partners’ P&L.

We fill the innovation gap by running key development activities, in particular pivotal clinical trials, then handing off global commercialization to large strategics who already have experienced, proven sales, marketing, manufacturing and distribution capabilities. It’s a capital-efficient approach that maximizes impact and upside.

2.  AVIM Therapy = Firmware for Pacemakers | Timestamp: 3:35–4:13

 Key Quote:
“Our therapy, AVIM, … is delivered as new programming, essentially firmware, integrated into a pacemaker… So, our therapy essentially is a program added to their established device that immediately, substantially, and persistently lowers blood pressure, a new capability for patients that takes advantage of a device that's been around for over 60 years.”

David compares OBIO’s AVIM (atrioventricular interval modulation) therapy conceptually to a firmware update such as the ones every consumer is familiar with from using smartphones, smart TVs, printers or even electric cars.

OBIO has innovated around the core software in pacemakers to enable entirely new capabilities to an existing device that’s proven, widely-used and essential to a large patient population. For patients who have, or are getting a pacemaker, OBIO is accumulating evidence that its therapeutic solution can drive significant blood pressure reduction, with no added hardware or procedures. The addressable market is based on a substantial existing market: over 1 million pacemakers are implanted each year, and the majority of those patients also suffer from hypertension.

3.  Breakthrough Device Designation Expands Regulatory Momentum | Timestamp: 8:14–8:45
   
   Key Quote:
   “We just were granted Breakthrough Device Designation by the FDA… This could help us gain approval for a broader indication of millions of patients, not just the pacemaker population.”

The FDA’s approval of breakthrough device designation is based on the established unmet need of patients as well as the novelty and therapeutic potential of AVIM therapy based on clinical results generated to date. The designation streamlines the regulatory process and supports potential pathways to secure higher reimbursement for AVIM-enabled devices in the future – overall supporting OBIO’s goal of expanding beyond the pacemaker population to treat other high-risk hypertensive patients.

Looking Ahead

The NYSE interview provides clear insights into Orchestra BioMed’s platform technologies, business model, and clinical strategy. The company was founded not only to advance innovations for major cardiovascular conditions such as hypertension, but to also prove that strategic partnership-enabled innovation can work as successfully for medtech as it has for pharma. AVIM therapy and the Medtronic partnership represent a powerful first chapter in that story.

As enrollment continues in the BACKBEAT Global Pivotal Study, OBIO remains focused on delivering long-term value to patients, partners, and shareholders alike.

— Team OBIO