Unlocking the Value of Virtue SAB with the Achievement of Two Major Milestones - Why Investors Should Take Notice
OBIO | AVIM Therapy Breakthrough Device Designation Shareholder Implications
This week marks a major milestone for Orchestra BioMed that has potentially significant implications for the commercial potential of AVIM therapy that OBIO is pursuing with its strategic partner, Medtronic.
OBIO | YESTERDAY’S FDA BREAKTHROUGH DEVICE DESIGNATION NEWS
Yesterday, we shared exciting news that Orchestra BioMed has been awarded FDA Breakthrough Device Designation for our novel AVIM therapy. If you missed the announcement, here’s a quick overview of this significant clinical and regulatory milestone:
OBIO | NYSE Interview: A Shareholder Guide and Key Takeaways
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:
- Partnership model adapted from pharma to medtech
- AVIM therapy is novel, always-on blood pressure treatment that is designed to be delivered as a firmware enhancement to a standard pacemaker
- 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
- 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.
- 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.
- 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
OBIO | AVIM Publications and Presentations Supplementary Explanation
AVIM therapy: Durability, Reversibility, and Reproducibility of Effect
Fellow Shareholders:
Recent clinical announcements related to our AVIM therapy program address three primary questions:
- How does AVIM therapy impact blood pressure and cardiovascular function over time?
- Is the effect durable and programmable over the long term?
- How does can this novel therapy fit into clinical practice in the future?
The August 14 publication in JACC: Advances focused on echocardiographic measures of cardiac function in patients with diastolic dysfunction. The later August publication in JACC: Clinical Electrophysiology analyzed the positive impact of AVIM therapy on blood pressure and cardiac hemodynamics using invasive and noninvasive pressure–volume (PV) loop measurements, considered by many to be the “gold standard” for comprehensive assessment of the activity of the heart. These AVIM therapy results were also assessed using standard pacing lead placement as well as lead placements intended to achieve conduction system pacing in the same patients. Conduction system pacing is a more advanced approach to cardiac pacing that is considered potentially safer and more effective and is rapidly being adopted by electrophysiologists. Most recently, our team presented data from a long-term washout study at the HRX Live 2025 Meeting (“HRX”), along with a summary of the technology simultaneously published in the peer-reviewed Heart Rhythm O2 journal.
What each recent AVIM therapy-related article highlights:
- Cardiac function (Aug 14; JACC: Advances): Echo-based analyses in patients with diastolic dysfunction, a key component in the development of heart failure with preserved ejection fraction (“HFpEF”), showed reductions in blood pressure with significant improvements in key attributes of ventricular function over 6 months.
- Mechanism and practicality (Aug 26; JACC: Clinical Electrophysiology): PV-loop findings detailed AVIM therapy’s favorable impact on cardiac hemodynamics, as well as the consistent effect observed across standard as well conduction system pacing approaches used in clinical practice.
- Durability and control (HRX): Long-term results following chronic treatment for over three and a half years with AVIM therapy supports a durable on-therapy effect. Upon deactivation of treatment, results showed a return to baseline blood pressures with AVIM therapy turned off. After a week-long therapy “washout” period, substantial blood pressure reduction was achieved when AVIM therapy was reactivated. These findings showcase the durability and programmability of significant blood pressure lowering effects as well as the utility for real-world device-based management of blood pressure in AVIM treated patients.
What’s new
At HRX, long-term follow-up from MODERATO II showed that, in a chronically-treated cohort of patients (n=16), 24-hour ambulatory systolic blood pressure (aSBP) reductions were sustained on therapy over a mean of 3.6 years (average change –8.9 mmHg; p<0.001). When AVIM was deactivated, aSBP returned to baseline with no evidence of rebound hypertension.
After a 7-day washout period, reactivation was associated with an immediate reduction in aSBP (p<0.002), to levels similar to prior on-therapy measurements - supporting reproducibility of effect.
What the Heart Rhythm O2 publication adds:
- Mechanistic framing: the mechanism of action positions AVIM therapy as a novel device-based approach to hypertension management, delivered via a dual-chamber pacemaker, that reduces cardiac preload and afterload while modulating autonomic tone.
- Clinical consistency: data from prior studies show immediate, substantial and sustained blood pressure reductions in pacemaker patients with uncontrolled hypertension, independent of lead position, with signals suggestive of favorable remodeling.
- Robust pivotal trial design: the ongoing large-scale BACKBEAT global pivotal study in collaboration with Medtronic is thoughtfully designed with the objective of establishing safety and efficacy with robust statistical significance as well as defining the potential role of AVIM therapy in clinical practice.
Why this matters for investors:
- The JACC: Electrophysiology, JACC: Advances, HRX observations, and Heart Rhythm O2 publication, provide peer-reviewed clinical evidence and new clinical results supporting the mechanism of action and positive clinical impact of AVIM therapy on patients with hypertensive heart disease.
- These communications are supportive and complementary to each other and continue to build on the body of evidence that, along with the key future results of the BACKBEAT global pivotal study, can support regulatory approval and commercial adoption of AVIM therapy in the future.
— Team OBIO
Forward-Looking Statements
Certain statements included in the content distributed by Orchestra BioMed Holdings, Inc. (the “Company”) to which this disclaimer relates (including, but not limited to, visual, auditory, or written statements) (the “Content”) that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements generally are accompanied by words such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “should,” “would,” “plan,” “predict,” “potential,” “seem,” “seek,” “future,” “outlook” and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements relating to the initiation, enrollment, timing, implementation and design of the Company’s planned and ongoing pivotal trials, the potential benefits of regulatory approvals or designations received from domestic and foreign regulatory bodies with respect to the Company’s product candidates and/or ongoing trials, the potential safety and efficacy of the Company’s product candidates, the ability of the Company’s partnerships to accelerate clinical development, the realization of the clinical and commercial value of the Company’s product candidates, and the Company’s ability to achieve expected regulatory and business milestones.. These statements are based on various assumptions, whether or not identified in the Content, and on the current expectations of the Company’s management and are not predictions of actual performance. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as and must not be relied on as a guarantee, an assurance, a prediction, or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and may differ from assumptions. Many actual events and circumstances are beyond the control of the Company. These forward-looking statements are subject to a number of risks and uncertainties, including changes in domestic and foreign business, market, financial, political, and legal conditions; risks related to regulatory approval of the Company’s commercial product candidates and ongoing regulation of the Company’s product candidates, if approved; the timing of, and the Company’s ability to achieve expected regulatory and business milestones; the impact of competitive products and product candidates; and the risk factors discussed under the heading “Item 1A. Risk Factors” in the Company’s annual report on Form 10-K filed with the SEC on March 31, 2025, and under the heading “Item 1A. Risk Factors” in the Company’s subsequently filed quarterly reports on Form 10-Q. The Company operates in a very competitive and rapidly changing environment. New risks emerge from time to time. Given these risks and uncertainties, the Company cautions against placing undue reliance on these forward-looking statements, which only speak as of the date of the Content. The Company does not plan and undertakes no obligation to update any of the forward-looking statements made in the Content, except as required by law.
First Quarter 2025 Business Highlights
First Quarter 2025 Business Highlights
Fellow Shareholders:
Orchestra BioMed has demonstrated good momentum so far in 2025 as we continue to execute on our mission of advancing high-impact cardiovascular innovations through strategic, capital-efficient partnerships.
Our two flagship programs – atrioventricular interval modulation (“AVIM”) therapy for hypertension and Virtue® Sirolimus AngioInfusion Balloon (“SAB”) for coronary artery disease - each achieved key U.S. Food and Drug Administration (“FDA”) and clinical milestones that deepen our conviction in their long-term potential.
Here are several highlights from our Q1 earnings announcement and business update that underscore our steady, value-focused approach:
Regulatory Progress Highlights AVIM’s Growing Clinical Relevance
- In March, AVIM therapy received Breakthrough Device Designation from the FDA for the treatment of uncontrolled hypertension in patients at increased cardiovascular risk, with or without pacemaker indication. This milestone builds on the growing body of clinical evidence related to AVIM therapy and could offer significant benefits in terms of regulatory efficiency and reimbursement upside.
- Meanwhile, our U.S. Virtue SAB program cleared an important milestone with full FDA approval of an IDE to initiate a head-to-head pivotal trial against a commercially available paclitaxel-coated balloon. We currently plan to begin this study in the second half of 2025.
Key CEO Callouts
David Hochman, OBIO’s Chairman and CEO, offered the following insights in this quarter’s update:
- “The FDA granting Breakthrough Device Designation to AVIM therapy... reflects growing recognition of our novel, proprietary therapy’s strong clinical foundation and potential to address critical unmet needs for millions of patients.”
- “Managing hypertension is crucial to prevent or slow the progression of hypertensive heart disease... We believe that AVIM therapy has the potential to provide a potent additional therapeutic option.”
- “We are focused on execution of the BACKBEAT global pivotal trial alongside our strategic partner Medtronic as the critical pathway toward making AVIM Therapy available to patients globally.”
As we move deeper into 2025, OBIO remains focused on disciplined execution, strategic clinical advancement, and building durable shareholder value through a methodical, partnership-driven approach.
With multiple FDA milestones achieved, ongoing enrollment in a global pivotal study, and a growing body of supportive clinical data, we believe OBIO is well-positioned for long-term impact.
We appreciate your continued support and look forward to updating you on our progress.
— Team OBIO
