Orchestra BioMed Announces AVIM Therapy-Focused Satellite Symposium at HRS 2025 Annual Meeting
Orchestra BioMed (NASDAQ: OBIO) announced a satellite symposium at the HRS 2025 Annual Meeting focusing on their atrioventricular interval modulation (AVIM) therapy program. The FDA recently granted Breakthrough Device Designation for AVIM therapy, targeting patients with uncontrolled hypertension and increased cardiovascular risk.
The symposium, scheduled for April 25, 2025, in San Diego, will feature presentations from leading experts discussing clinical results showing AVIM therapy's effectiveness in reducing systolic blood pressure and improving cardiac function. Orchestra BioMed estimates over 7.7 million U.S. patients meet the criteria for AVIM therapy.
The company is currently enrolling patients in the BACKBEAT global pivotal study in collaboration with Medtronic (NYSE: MDT), evaluating AVIM therapy for uncontrolled hypertension in patients with dual-chamber pacemakers.
Orchestra BioMed (NASDAQ: OBIO) ha annunciato un simposio satellite al Congresso Annuale HRS 2025, incentrato sul loro programma di terapia di modulazione dell'intervallo atrioventricolare (AVIM). La FDA ha recentemente concesso la Designazione di Dispositivo Innovativo per la terapia AVIM, rivolta a pazienti con ipertensione non controllata e aumentato rischio cardiovascolare.
Il simposio, previsto per il 25 aprile 2025 a San Diego, presenterà interventi di esperti di rilievo che discuteranno i risultati clinici dimostrando l'efficacia della terapia AVIM nella riduzione della pressione sistolica e nel miglioramento della funzione cardiaca. Orchestra BioMed stima che oltre 7,7 milioni di pazienti negli Stati Uniti soddisfano i criteri per la terapia AVIM.
La società sta attualmente reclutando pazienti per lo studio globale pivotale BACKBEAT, in collaborazione con Medtronic (NYSE: MDT), che valuta la terapia AVIM per l'ipertensione non controllata in pazienti con pacemaker a doppia camera.
Orchestra BioMed (NASDAQ: OBIO) anunció un simposio satélite en la Reunión Anual HRS 2025 centrado en su programa de terapia de modulación del intervalo auriculoventricular (AVIM). La FDA otorgó recientemente la Designación de Dispositivo Innovador para la terapia AVIM, dirigida a pacientes con hipertensión no controlada y mayor riesgo cardiovascular.
El simposio, programado para el 25 de abril de 2025 en San Diego, contará con presentaciones de expertos líderes que discutirán resultados clínicos que demuestran la eficacia de la terapia AVIM para reducir la presión arterial sistólica y mejorar la función cardíaca. Orchestra BioMed estima que más de 7.7 millones de pacientes en EE. UU. cumplen con los criterios para la terapia AVIM.
La compañía está actualmente reclutando pacientes para el estudio global pivotal BACKBEAT, en colaboración con Medtronic (NYSE: MDT), que evalúa la terapia AVIM para hipertensión no controlada en pacientes con marcapasos bicamerales.
Orchestra BioMed (NASDAQ: OBIO)는 AVIM(방실 간격 조절) 치료 프로그램에 초점을 맞춘 2025년 HRS 연례회의 위성 심포지엄을 발표했습니다. FDA는 최근 통제되지 않은 고혈압 및 심혈관 위험 증가 환자를 대상으로 하는 AVIM 치료에 대해 혁신 의료기기 지정을 승인했습니다.
2025년 4월 25일 샌디에이고에서 예정된 심포지엄에서는 주요 전문가들이 AVIM 치료가 수축기 혈압 감소와 심장 기능 개선에 효과적임을 입증한 임상 결과를 발표할 예정입니다. Orchestra BioMed는 미국에서 770만 명 이상의 환자가 AVIM 치료 대상 기준에 부합한다고 추산합니다.
회사는 현재 Medtronic(NYSE: MDT)과 협력하여 이중 챔버 심박조율기 환자의 통제되지 않은 고혈압에 대한 AVIM 치료를 평가하는 글로벌 주요 연구 BACKBEAT에 환자를 모집 중입니다.
Orchestra BioMed (NASDAQ : OBIO) a annoncé un symposium satellite lors de la réunion annuelle HRS 2025, axé sur leur programme de thérapie par modulation de l'intervalle atrioventriculaire (AVIM). La FDA a récemment accordé la désignation de dispositif révolutionnaire pour la thérapie AVIM, ciblant les patients souffrant d'hypertension non contrôlée et présentant un risque cardiovasculaire accru.
Le symposium, prévu le 25 avril 2025 à San Diego, comprendra des présentations d'experts de premier plan discutant des résultats cliniques démontrant l'efficacité de la thérapie AVIM pour réduire la pression artérielle systolique et améliorer la fonction cardiaque. Orchestra BioMed estime que plus de 7,7 millions de patients aux États-Unis répondent aux critères pour la thérapie AVIM.
L'entreprise recrute actuellement des patients pour l'étude pivot mondiale BACKBEAT, en collaboration avec Medtronic (NYSE : MDT), évaluant la thérapie AVIM pour l'hypertension non contrôlée chez les patients porteurs de stimulateurs cardiaques bicavitaires.
Orchestra BioMed (NASDAQ: OBIO) kündigte ein Satellitensymposium auf der HRS Jahrestagung 2025 an, das sich auf ihr Programm zur Modulation des atrioventrikulären Intervalls (AVIM) konzentriert. Die FDA hat kürzlich die Breakthrough Device Designation für die AVIM-Therapie erteilt, die sich an Patienten mit unkontrolliertem Bluthochdruck und erhöhtem kardiovaskulärem Risiko richtet.
Das Symposium, geplant für den 25. April 2025 in San Diego, wird Präsentationen führender Experten enthalten, die klinische Ergebnisse vorstellen, welche die Wirksamkeit der AVIM-Therapie bei der Senkung des systolischen Blutdrucks und der Verbesserung der Herzfunktion zeigen. Orchestra BioMed schätzt, dass über 7,7 Millionen US-Patienten die Kriterien für die AVIM-Therapie erfüllen.
Das Unternehmen rekrutiert derzeit Patienten für die globale Schlüsselerhebung BACKBEAT in Zusammenarbeit mit Medtronic (NYSE: MDT), die die AVIM-Therapie bei unkontrolliertem Bluthochdruck bei Patienten mit Zweikammer-Schrittmachern bewertet.
- FDA Breakthrough Device Designation received for AVIM therapy
- Large addressable market of 7.7M U.S. patients
- Strategic collaboration with Medtronic (NYSE: MDT)
- Clinical data shows immediate and substantial blood pressure reduction
- AVIM therapy still in clinical trial phase, not yet approved for commercial use
- to patients with specific cardiovascular conditions
Insights
FDA Breakthrough Designation for AVIM therapy validates Orchestra BioMed's approach to treating hypertension, with pivotal trial ongoing in partnership with Medtronic.
Orchestra BioMed has secured a significant Breakthrough Device Designation (BDD) from the FDA for its atrioventricular interval modulation (AVIM) therapy. This designation specifically targets patients with uncontrolled hypertension who have increased 10-year atherosclerotic cardiovascular disease risk, preserved left ventricular systolic function, and either inadequate response to anti-hypertensive medications or medication intolerance.
The BDD represents regulatory recognition of both the unmet clinical need and the potential significance of Orchestra BioMed's approach. The company estimates an addressable U.S. market of over 7.7 million patients meeting these criteria, highlighting the substantial market opportunity if the therapy proves successful in ongoing trials.
Orchestra BioMed is currently enrolling patients in the BACKBEAT global pivotal study, conducted under an investigational device exemption. This study specifically evaluates AVIM therapy for uncontrolled hypertension in patients who already have dual-chamber pacemakers. The company is conducting this pivotal trial in strategic collaboration with Medtronic, a leading medical device company, providing important validation of the technology's potential.
The upcoming satellite symposium at the Heart Rhythm Society 2025 Annual Meeting will showcase data from the MODERATO I & II studies, which according to the company have demonstrated AVIM therapy's ability to reduce systolic blood pressure and improve cardiac function. These earlier clinical results will provide context for the ongoing pivotal study and help establish the scientific foundation for the therapy's regulatory pathway.
AVIM therapy shows promise for treating uncontrolled hypertension through novel cardiac pacing approach, with potential benefits for cardiac function beyond blood pressure.
Orchestra BioMed's atrioventricular interval modulation (AVIM) therapy represents an innovative approach to hypertension management through cardiac pacing intervention. The therapy works by modulating the timing between atrial and ventricular contractions, which can produce beneficial hemodynamic effects in patients with elevated blood pressure.
The FDA's Breakthrough Device Designation confirms the significant unmet need in higher-risk hypertensive patients, particularly those who remain uncontrolled despite medication or cannot tolerate antihypertensive drugs. This patient population faces substantially elevated cardiovascular risk and often has therapeutic options.
According to the announcement, previous clinical studies (MODERATO I & II) have shown AVIM therapy can produce immediate, substantial and persistent reductions in systolic blood pressure. Additionally, the therapy appears to provide improvements in cardiac function, including effects on diastolic dysfunction, suggesting broader cardiovascular benefits beyond simple blood pressure reduction.
The BACKBEAT global pivotal study currently enrolling patients will be crucial in establishing definitive evidence for this approach. The study specifically targets patients who already require dual-chamber pacemakers and have uncontrolled hypertension despite medications, potentially providing a first-line indication if successful.
The involvement of prominent clinical researchers including Dr. Vivek Reddy (Mount Sinai), Prof. Karl-Heinz Kuck (University Heart Center Lübeck), Dr. Marat Fudim (Duke), and Dr. Andrea Russo (Cooper University) in the upcoming symposium adds significant scientific credibility to the program and suggests broad clinical interest in this novel approach to managing uncontrolled hypertension.
- 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)
NEW HOPE, Pa., April 23, 2025 (GLOBE NEWSWIRE) -- 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 25th, 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.
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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
FAQ
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