MARKET WIRE NEWS

Orchestra BioMed to Host Business Update Call on November 12, 2025

MWN-AI** Summary

Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO), a biomedical innovation company based in New Hope, Pennsylvania, has announced a business update call scheduled for November 12, 2025, at 8:00 AM ET. During this call, company management will discuss significant recent developments regarding clinical trials, strategic partnerships, and financing efforts. Notably, the update will include a new strategic investment and collaboration expansion with Medtronic, a leading global medical device company, which is integral to the development and commercialization of Orchestra's Atrioventricular Interval Modulation (AVIM) Therapy.

AVIM Therapy is a breakthrough bioelectronic treatment for hypertension—an urgent global health risk—and has received FDA Breakthrough Device Designation. This therapy is designed to be administered through existing pacemakers, potentially benefiting approximately 7.7 million patients in the U.S. who suffer from uncontrolled hypertension despite other treatments.

Additionally, the call will cover the initiation of patient enrollment for the pivotal IDE coronary trial of Orchestra's Virtue® Sirolimus AngioInfusion™ Balloon (Virtue SAB). The Virtue SAB is a novel drug delivery system targeting atherosclerotic artery disease and has also been awarded Breakthrough Device Designation by the FDA.

Participants can join the call by dialing toll-free at 877-407-9039 or internationally at 201-689-8470, and the conference ID is 13756518. The event will also be accessible via a webcast link.

Orchestra BioMed aims to bring transformative technologies to market through these strategic collaborations, positioning itself to address significant unmet medical needs across extensive global market opportunities. For more information, visit their website or follow their LinkedIn page.

MWN-AI** Analysis

As Orchestra BioMed (Nasdaq: OBIO) prepares for its business update call on November 12, 2025, investors should closely analyze the implications of the company’s recent strategic developments. The call will spotlight crucial updates, including expanded collaboration with Medtronic, a new partnership with Ligand, and pivotal progress in clinical trials for its flagship products, Atrioventricular Interval Modulation (AVIM) Therapy and Virtue® Sirolimus AngioInfusion™ Balloon (Virtue SAB).

The collaboration with Medtronic not only reinforces Orchestra BioMed's credibility but also amplifies its market reach in a sector poised for significant growth. With AVIM Therapy targeting uncontrolled hypertension, which affects millions in the U.S. alone, and holding FDA Breakthrough Device Designation, the potential for market capture is substantial. Furthermore, the initiation of patient enrollment in the pivotal BACKBEAT study demonstrates proactive measures that could accelerate product development timelines.

Investors should also note the new strategic capital relationship with Ligand and the right of first refusal agreement with Terumo, which could signal enhanced financial stability and strategic opportunities. The alignment with established players enhances the company's potential for successful commercialization while spreading risk through diverse partnerships.

With both the AVIM Therapy and Virtue SAB addressing critical medical needs in cardiovascular health, investors could see these products as market disruptors. The upcoming call may provide key insights into management's strategic vision, financial health, and timelines for clinical milestones.

For those considering entering or holding positions in Orchestra BioMed, monitoring the company's communication during the call will be crucial. Positive news could catalyze stock price movement, while any concerns revealed about trial progress or funding may prompt reevaluation. Overall, the firm’s enhanced strategic collaborations and promising clinical advancements position it favorably within a dynamic market landscape.

**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news release.

Source: GlobeNewswire

NEW HOPE, Pa., Nov. 03, 2025 (GLOBE NEWSWIRE) -- Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO) (“Orchestra BioMed” or the “Company”), a biomedical company accelerating high-impact technologies to patients through strategic partnerships with market-leading global medical device companies, today announced that company management will host a business update call on Wednesday, November 12 th at 8:00 AM ET.

The business update will focus on recent significant clinical, strategic and financing developments, including the Company’s additional strategic investment from and collaboration expansion with Medtronic, its new strategic capital relationship with Ligand, its new right of first refusal agreement with Terumo, acceleration of enrollment in the BACKBEAT pivotal study of AVIM Therapy, the initiation of patient enrollment in the Virtue SAB US pivotal IDE coronary trial.

Conference Call Details
Wednesday, November 12, at 8:00 AM Eastern Time
Toll Free: 877-407-9039
International: 201-689-8470
Conference ID: 13756518
Webcast: https://viavid.webcasts.com/starthere.jsp?ei=1738644&tp_key=c80bc7995c

About Orchestra BioMed
Orchestra BioMed is a biomedical innovation company accelerating high-impact technologies to patients through strategic collaborations with market-leading global medical device companies. The Company’s two flagship product candidates - Atrioventricular Interval Modulation (AVIM) Therapy and Virtue® Sirolimus AngioInfusion™ Balloon (Virtue SAB) - are currently undergoing pivotal clinical trials for their lead indications, each representing multi-billion-dollar annual global market opportunities. AVIM Therapy is a bioelectronic treatment for hypertension, the leading risk factor for death worldwide, and is designed to be delivered as a firmware upgrade to a pacemaker and achieve immediate, substantial and sustained reductions in blood pressure in patients with hypertensive heart disease. The Company has a strategic collaboration with Medtronic (NYSE: MDT), one of the largest medical device companies in the world, for the development and commercialization of AVIM Therapy for the treatment of uncontrolled hypertension in pacemaker-indicated patients. AVIM Therapy has FDA Breakthrough Device Designation for these patients, as well as an estimated 7.7 million total patients in the U.S. with uncontrolled hypertension despite medical therapy and increased cardiovascular risk. Virtue SAB is a highly differentiated, first-of-its-kind drug delivery angioplasty balloon system designed to deliver a proprietary extended-release formulation of sirolimus, SirolimusEFR™, for the treatment of atherosclerotic artery disease, the leading cause of mortality worldwide. Virtue SAB has been granted Breakthrough Device Designation by the FDA for the treatment of coronary ISR, coronary small vessel disease and below-the-knee peripheral artery disease. For further information about Orchestra BioMed, please visit www.orchestrabiomed.com , and follow us on LinkedIn .

Investor Contact:
Silas Newcomb
Orchestra BioMed
Snewcomb@orchestrabiomed.com

Media Contact:
Kelsey Kirk-Ellis
Orchestra BioMed
kkirkellis@orchestrabiomed.com


FAQ**

How does the strategic investment from Medtronic impact the development timeline for Orchestra BioMed Holdings Inc Com OBIO's AVIM Therapy and what specific synergies are expected from this collaboration?

Medtronic's strategic investment in Orchestra BioMed Holdings Inc. is expected to accelerate the development timeline for the AVIM Therapy by providing funding and resources, resulting in synergies such as enhanced R&D capabilities, market access, and shared expertise in device technology.

Can you elaborate on the significance of the new strategic capital relationship with Ligand for Orchestra BioMed Holdings Inc Com OBIO in terms of funding and resource allocation for ongoing clinical trials?

The new strategic capital relationship with Ligand is significant for Orchestra BioMed Holdings Inc (OBIO) as it enhances funding and resource allocation, enabling the acceleration of ongoing clinical trials and bolstering the company's innovation in therapeutic solutions.

What are the anticipated outcomes and next steps following the initiation of patient enrollment in the Virtue SAB US pivotal IDE coronary trial for Orchestra BioMed Holdings Inc Com OBIO?

The anticipated outcomes following patient enrollment in the Virtue SAB US pivotal IDE coronary trial for Orchestra BioMed Holdings Inc (OBIO) include collecting crucial efficacy and safety data to support regulatory submissions, with next steps focusing on monitoring trial progress and interim results.

How does the right of first refusal agreement with Terumo enhance the strategic position of Orchestra BioMed Holdings Inc Com OBIO in the competitive landscape of biomedical innovations?

The right of first refusal agreement with Terumo strengthens Orchestra BioMed Holdings Inc by securing potential partnerships for innovative products, enhancing its competitive edge and facilitating access to advanced resources and market opportunities in biomedical innovations.

**MWN-AI FAQ is based on asking OpenAI questions about Orchestra BioMed Holdings Inc Com (NASDAQ: OBIO).

Orchestra BioMed Holdings Inc Com

NASDAQ: OBIO

OBIO Trading

-3.09% G/L:

$4.555 Last:

82,013 Volume:

$4.60 Open:

mwn-alerts Ad 300

OBIO Latest News

OBIO Stock Data

$235,457,928
31,902,573
2.32%
5
N/A
Biotechnology & Life Sciences
Healthcare
US
New Hope

Subscribe to Our Newsletter

Link Market Wire News to Your X Account

Download The Market Wire News App