Orchestra BioMed Courts Investors with Breakthrough Heart Therapies

NEW HOPE, PA – February 19, 2026 – Orchestra BioMed is preparing to take its story on the road, with management scheduled to present at two major institutional investor conferences in March. The company, which is developing a pair of potentially transformative cardiovascular therapies, will engage with the financial community at the TD Cowen 46th Annual Health Care Conference in Boston and the Barclays 28th Annual Global Healthcare Conference in Miami.

For a company like Orchestra BioMed (Nasdaq: OBIO), these high-profile events are more than just a calendar entry; they are a critical platform to articulate the value of its clinical-stage assets. The company is advancing two flagship candidates, both in pivotal trials and both granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA). The first, Atrioventricular Interval Modulation (AVIM) Therapy, is a novel bioelectronic treatment for hypertension. The second, the Virtue® Sirolimus AngioInfusion™ Balloon (Virtue SAB), is designed to treat atherosclerotic artery disease. As the company navigates the expensive and lengthy process of late-stage clinical development, communicating its progress and potential to investors is paramount.

The Strategic Investor Pitch

Participation in premier healthcare conferences is a core component of Orchestra BioMed’s strategy to maintain visibility and secure investor confidence. The fireside chats and one-on-one meetings scheduled for the TD Cowen and Barclays conferences offer an opportunity to provide updates on its two pivotal trials and reinforce its unique “partnership-enabled” business model. This model, which focuses on collaborating with established market leaders, is central to the company’s narrative.

For a biomedical company with products years from potential commercialization, investor confidence is the lifeblood that sustains long-term development. The funds raised and partnerships secured today are what will carry its therapies through the rigorous FDA approval process. Recent capital infusions, including a significant $70 million secured in mid-2025, have provided the company with a cash runway expected to last into the fourth quarter of 2027. This funding is critical, as it is projected to see the company through the completion of patient enrollment in both of its pivotal trials and past the primary endpoint data readout for its AVIM Therapy trial. Presenting a clear, confident vision at these conferences is essential to reassuring the market that the company is on a stable path toward these key milestones.

A New Rhythm for Blood Pressure Control

At the heart of Orchestra BioMed’s pipeline is AVIM Therapy, a bioelectronic therapy aimed at treating uncontrolled hypertension in patients who are already indicated for a cardiac pacemaker. Instead of a new drug or a separate implant, AVIM Therapy is designed to be delivered as a simple firmware upgrade to standard dual-chamber pacemakers. This approach to cardiac neuromodulation works by subtly adjusting the heart's pacing sequence to lower blood pressure.

The unmet need is substantial. Hypertension is a leading risk factor for death worldwide, and millions of patients remain hypertensive despite medication. The company estimates that in the U.S. alone, 7.7 million patients with uncontrolled hypertension and increased cardiovascular risk could be eligible for this therapy under its FDA Breakthrough Device Designation.

The treatment is currently being evaluated in the global BACKBEAT pivotal study. This randomized, double-blind trial aims to enroll approximately 500 patients who have recently received a Medtronic pacemaker. The study's primary goal is to demonstrate a significant reduction in blood pressure at three months compared to a sham control. Enrollment began in late 2023, and a recent protocol amendment that broadened patient eligibility criteria is expected to accelerate recruitment through 2026. Confidence in the trial is supported by promising data from earlier pilot studies, which showed statistically and clinically significant reductions in both ambulatory and office blood pressure readings.

Redefining Artery Treatment with Virtue SAB

Orchestra BioMed’s second flagship product, the Virtue Sirolimus AngioInfusion™ Balloon, targets atherosclerotic artery disease, the leading cause of mortality worldwide. Virtue SAB is a first-of-its-kind therapeutic device designed for conditions like coronary in-stent restenosis (ISR), where a previously placed stent becomes narrowed again. ISR affects up to 10% of stent patients and presents a difficult treatment challenge.

Unlike existing drug-coated balloons that use paclitaxel, Virtue SAB utilizes a proprietary, extended-release formulation of sirolimus (SirolimusEFR™). What makes the technology unique is its delivery system: a non-coated, microporous balloon that protects the drug during transit and then infuses it directly into the artery wall upon inflation. This is designed to ensure the drug reaches the target tissue and remains at therapeutic levels during the critical 30-day healing period.

The device is being tested in the VIRTUE pivotal trial, which began enrolling patients in late 2025. In a bold move, the trial is a head-to-head comparison against the only FDA-approved drug-coated balloon for coronary use, Boston Scientific’s AGENT™ paclitaxel DCB. The trial will assess whether Virtue SAB is non-inferior for Target Lesion Failure at 12 months. The potential is significant, as the device has also received Breakthrough Device Designations for treating coronary small vessel disease and below-the-knee peripheral artery disease, opening up further multi-billion-dollar market opportunities.

The Power of Partnership: A Blueprint for MedTech Success

Perhaps the most compelling aspect of Orchestra BioMed’s strategy is its deep collaboration with Medtronic, one of the world's largest medical device companies. The global strategic partnership, focused on the development and commercialization of AVIM Therapy, serves as a powerful validation of the technology and significantly de-risks its path to market.

Under the agreement, Medtronic provides development, clinical, and regulatory support for the BACKBEAT pivotal trial. Should the therapy receive FDA approval, Medtronic will have exclusive global rights to commercialize AVIM-enabled pacing systems. Orchestra BioMed, in turn, will receive a share of the revenue. This arrangement allows Orchestra to focus on innovation while leveraging Medtronic’s vast manufacturing scale and commercial infrastructure.

Medtronic has put significant capital behind the partnership, with nearly $62 million in equity investments and further commitments of over $50 million in convertible notes and other financing. This financial backing not only funds the pivotal trial but also aligns the interests of both companies. The partnership has already been expanded to explore the future development of AVIM therapy for leadless pacemakers, demonstrating a long-term commitment to the platform's potential.

Navigating the Market and Investor Expectations

With two breakthrough-designated products in pivotal trials and a strategic partnership with an industry titan, Orchestra BioMed presents a compelling case to investors. Analyst sentiment reflects this potential, with a consensus “Moderate Buy” rating and price targets suggesting significant upside from its current stock price. Key drivers for this optimism include the massive market opportunities—estimated in the multi-billions for both hypertension and atherosclerotic disease—and the de-risking provided by the Medtronic collaboration and a strong cash position.

However, the company is not without the risks inherent to the biotech sector. It has a history of operating losses, and its future success hinges entirely on the outcomes of its ongoing clinical trials, which are long, expensive, and never guaranteed. While the company is funded through key near-term milestones, managing its cash burn remains a focus.

As management prepares for its March presentations, they will be tasked with balancing the immense promise of their technology with the realities of clinical development. Investors will be listening closely for updates on trial enrollment, regulatory timelines, and the enduring strength of its strategic partnerships. The coming months will be critical as Orchestra BioMed works to transform its innovative science into a new standard of care for millions of patients worldwide.