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- FDA recently granted Breakthrough Device Designation to AVIM therapy for use in patients with uncontrolled hypertension at increased cardiovascular risk
- HRS Satellite Symposium will feature leading experts in electrophysiology, hypertension management and heart failure
- Presentations will detail clinical results from prior studies demonstrating AVIM therapy's ability to immediately, substantially and persistently reduce systolic blood pressure, as well as improve cardiac function
- Symposium will also feature presentation on the BACKBEAT global pivotal study Orchestra BioMed is currently enrolling in strategic collaboration with Medtronic, plc (NYSE: MDT)
Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO, "Orchestra BioMed" or the "Company"), a biomedical company accelerating high-impact technologies to patients through risk-reward sharing partnerships, today announced it will host an industry-sponsored satellite symposium at the Heart Rhythm Society ("HRS") 2025 Annual Meeting, taking place April 24–27, 2025, in San Diego, California featuring recent advancements in the Company's atrioventricular interval modulation ("AVIM") therapy program. The April 25 th 6:45 am PT symposium titled " The Future of Cardiac Pacing: Unlocking the Potential of Atrioventricular Interval Modulation (AVIM) Therapy " will convene leading electrophysiologists, hypertension and heart failure specialists to discuss the unmet need in hypertension, AVIM therapy mechanism of action, and growing body of clinical evidence supporting this novel therapy for the treatment of patients with uncontrolled hypertension who have increased cardiovascular risk with or without an indication for a pacemaker.
"The FDA's recent grant of Breakthrough Device Designation to AVIM therapy for the treatment of hypertension in patients with increased cardiovascular risk, regardless of whether they are indicated for a pacemaker, underscores the significant unmet need in higher risk patients as well as the strength of the clinical data generated to date on AVIM therapy," commented Vivek Reddy, M.D., Director of Cardiac Arrhythmia Services at The Mount Sinai Fuster Heart Hospital, Director of Electrophysiology for the Mount Sinai Health System, and Executive Chairman of the BACKBEAT Study Steering Committee. "I'm excited to chair the session at HRS alongside my esteemed colleagues to provide a comprehensive overview of the clinical evidence and mechanistic data supporting the potential for AVIM therapy to transform hypertension management in older, higher risk patient populations."
The U.S. Food and Drug Administration recently granted Breakthrough Device Designation ("BDD") for AVIM therapy. Specifically, the BDD is for an implantable system (i.e., a pacemaker) to deliver AVIM therapy using conduction system pacing to reduce blood pressure in patients with increased 10-year atherosclerotic cardiovascular disease ("ASCVD") risk, preserved left ventricular systolic function, and uncontrolled hypertension, despite the use of anti-hypertensive medications or in patients who may have intolerance to anti-hypertensive medications. Orchestra BioMed estimates that there are over 7.7 million U.S. patients that meet the criteria for the BDD for AVIM therapy. Orchestra BioMed, in collaboration with Medtronic, is currently enrolling the BACKBEAT global pivotal study, an investigational device exemption ("IDE") study evaluating AVIM therapy for the treatment of uncontrolled hypertension despite the use of anti-hypertensive medication in patients who have a dual-chamber pacemaker.
Satellite Symposium Details:
Title: The Future of Cardiac Pacing: Unlocking the Potential of Atrioventricular Interval Modulation ("AVIM") Therapy
Date: Friday, April 25, 2025
Time: 6:45-8:00am PT
Location: Hilton San Diego Bayfront Hotel, Indigo Ballroom CG
Presentation Topics and Presenters Include:
- The Future of Cardiac Pacing: Unmet Hypertension Need in Patients with Increased Cardiovascular Risk and Evidence Supporting AVIM Therapy Mechanism of Action , presented by Vivek Reddy, M.D. , Mount Sinai Hospital
- AVIM Therapy Impact on Hypertension: Results from the MODERATO I & II Studies , presented by Prof. Karl-Heinz Kuck, M.D. , University Heart Center Lübeck
- AVIM Therapy Impact on Diastolic Dysfunction: Results from the MODERATO II Study , presented by Marat Fudim, M.D., M.H.S. , Duke University
- Rationale and Design of the BACKBEAT Global Pivotal Study , presented by Andrea Russo, M.D., FACC, FHRS, FAHA, Cooper University Hospital
About Orchestra BioMed
Orchestra BioMed (Nasdaq: OBIO) is a biomedical innovation company accelerating high-impact technologies to patients through risk-reward sharing partnerships with leading medical device companies. Orchestra BioMed's partnership-enabled business model focuses on forging strategic collaborations with leading medical device companies to drive successful global commercialization of products it develops. Orchestra BioMed's lead product candidate is atrioventricular interval modulation (AVIM) therapy (also known as BackBeat Cardiac Neuromodulation Therapy (CNT™)) for the treatment of hypertension, the leading risk factor for death worldwide. Orchestra BioMed is also developing the Virtue ® Sirolimus AngioInfusion™ Balloon (SAB) for the treatment of atherosclerotic artery disease, the leading cause of mortality worldwide. Orchestra BioMed has a strategic collaboration with Medtronic, one of the largest medical device companies in the world, for development and commercialization of AVIM therapy for the treatment of hypertension in pacemaker-indicated patients, and a strategic partnership with Terumo, a global leader in medical technology, for development and commercialization of Virtue SAB for the treatment of artery disease. For further information about Orchestra BioMed, please visit www.orchestrabiomed.com , and follow us on LinkedIn .
References to Websites and Social Media Platforms
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About AVIM Therapy
AVIM therapy is an investigational therapy compatible with standard dual-chamber pacemakers designed to substantially and persistently lower blood pressure. It has been evaluated in pilot studies in patients with hypertension who are also indicated for a pacemaker. MODERATO II, a double-blind, randomized pilot study, showed that patients treated with AVIM therapy experienced net reductions of 8.1 mmHg in 24-hour ambulatory systolic blood pressure (aSBP) and 12.3 mmHg in office systolic blood pressure (oSBP) at six months when compared to control patients. In addition to reducing blood pressure, clinical results using AVIM therapy demonstrate improvements in cardiac function and hemodynamics. The BACKBEAT (BradycArdia paCemaKer with atrioventricular interval modulation for Blood prEssure treAtmenT) global pivotal study will further evaluate the safety and efficacy of AVIM therapy in lowering blood pressure in patients who have systolic blood pressure above target despite anti-hypertensive medication and who are indicated for or have recently received a dual-chamber cardiac pacemaker.
About the FDA Breakthrough Device Program
The FDA Breakthrough Device Program, established in 2015, is designed to expedite the development, review, and potential market access of medical devices that may offer more effective treatment or diagnosis for life-threatening or irreversibly debilitating conditions. The designation provides manufacturers with prioritized FDA review and early, frequent interactions with agency experts to efficiently address development and regulatory considerations. Breakthrough status may also support streamlined reimbursement pathways, including eligibility for New Technology Add-on Payments (NTAP) and Transitional Pass-Through Payments (TPT), by helping to demonstrate substantial clinical improvement.
Forward-Looking Statements
Certain statements included in this press release 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, realizing the clinical and commercial value of AVIM therapy and Virtue SAB, and the potential safety and efficacy of the Company's product candidates, including the ability of AVIM therapy to favorably influence ventricular function, implementation of the Company's ongoing BACKBEAT global pivotal study, the potential benefits of BDD, including its ability to expedite FDA reviews and streamline reimbursement pathways,. These statements are based on various assumptions, whether or not identified in this press release, 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 for the year ended December 31, 2024, which was filed with the Securities and Exchange Commission on March 31, 2025, and under the heading "Item1A. Risk Factors" in Part II of 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 this press release. The Company does not plan and undertakes no obligation to update any of the forward-looking statements made herein, except as required by law.
Investor Contact
Jeremy Feffer
LifeSci Advisors
Jfeffer@lifesciadvisors.com
Media Contact
Kelsey Kirk-Ellis
Orchestra BioMed
kkirkellis@orchestrabiomed.com
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