Orchestra BioMed Appoints Vivek Reddy, M.D. as Executive Chairman of the BACKBEAT Study Steering Committee and Chairman of Bioelectronic Therapies Scientific Advisory Board
Orchestra BioMed Holdings (Nasdaq: OBIO) has appointed Dr. Vivek Reddy as Executive Chairman of the BACKBEAT Study Steering Committee and Chairman of its Bioelectronic Therapies Scientific Advisory Board. Dr. Reddy, currently Director of Cardiac Arrhythmia Services at Mount Sinai, will lead the execution of the BACKBEAT global pivotal study, which evaluates the efficacy and safety of atrioventricular interval modulation (AVIM) therapy for patients with uncontrolled hypertension and pacemaker indication.
The AVIM therapy represents a potential always-on, adjustable hypertension treatment that doesn't rely on patient adherence. Dr. Reddy will focus on completing the BACKBEAT study and coordinating efforts among clinical advisors to realize AVIM therapy's potential for hypertension populations with increased cardiovascular risk. The company is also exploring additional therapeutic applications for this technology.
Orchestra BioMed Holdings (Nasdaq: OBIO) ha nominato il Dr. Vivek Reddy come Presidente Esecutivo del Comitato Direttivo dello Studio BACKBEAT e Presidente del suo Comitato Consultivo Scientifico sulle Terapie Bioelettroniche. Il Dr. Reddy, attualmente Direttore dei Servizi di Aritmia Cardiaca al Mount Sinai, guiderà l'esecuzione dello studio globale BACKBEAT, che valuta l'efficacia e la sicurezza della terapia di modulazione dell'intervallo atrioventricolare (AVIM) per pazienti con ipertensione non controllata e indicazione per pacemaker.
La terapia AVIM rappresenta un potenziale trattamento per l'ipertensione sempre attivo e regolabile che non dipende dall'aderenza del paziente. Il Dr. Reddy si concentrerà sul completamento dello studio BACKBEAT e sul coordinamento degli sforzi tra i consulenti clinici per realizzare il potenziale della terapia AVIM per le popolazioni ipertensive con un rischio cardiovascolare aumentato. L'azienda sta anche esplorando ulteriori applicazioni terapeutiche per questa tecnologia.
Orchestra BioMed Holdings (Nasdaq: OBIO) ha designado al Dr. Vivek Reddy como Presidente Ejecutivo del Comité Directivo del Estudio BACKBEAT y Presidente de su Consejo Asesor Científico de Terapias Bioelectrónicas. El Dr. Reddy, actualmente Director de Servicios de Arritmias Cardíacas en Mount Sinai, liderará la ejecución del estudio pivotal global BACKBEAT, que evalúa la eficacia y seguridad de la terapia de modulación del intervalo auriculoventricular (AVIM) para pacientes con hipertensión no controlada e indicación de marcapasos.
La terapia AVIM representa un tratamiento potencial para la hipertensión que está siempre activo y es ajustable, sin depender de la adherencia del paciente. El Dr. Reddy se enfocará en completar el estudio BACKBEAT y coordinar los esfuerzos entre los asesores clínicos para realizar el potencial de la terapia AVIM en poblaciones hipertensas con mayor riesgo cardiovascular. La empresa también está explorando aplicaciones terapéuticas adicionales para esta tecnología.
오케스트라 바이오메드 홀딩스 (Nasdaq: OBIO)는 백비트 연구 운영 위원회 의장 및 생체 전자 치료 과학 자문 위원회 의장으로 Dr. Vivek Reddy를 임명했습니다. 현재 마운트 시나이에서 심장 부정맥 서비스 이사로 활동 중인 Dr. Reddy는 조절되지 않는 고혈압 및 심박조율기 적응증이 있는 환자를 위한 방실 간격 조절(AVIM) 치료의 효능과 안전성을 평가하는 글로벌 주요 연구인 BACKBEAT 연구의 실행을 이끌게 됩니다.
AVIM 치료는 환자의 순응도에 의존하지 않는 항상 켜져 있고 조정 가능한 고혈압 치료를 나타냅니다. Dr. Reddy는 BACKBEAT 연구를 완료하고 심혈관 위험이 증가한 고혈압 인구를 위한 AVIM 치료의 잠재력을 실현하기 위해 임상 자문과의 협력을 조정하는 데 집중할 것입니다. 또한 회사는 이 기술에 대한 추가 치료 응용 프로그램을 탐색하고 있습니다.
Orchestra BioMed Holdings (Nasdaq: OBIO) a nommé le Dr Vivek Reddy en tant que Président Exécutif du Comité de Pilotage de l'Étude BACKBEAT et Président de son Conseil Consultatif Scientifique sur les Thérapies Bioélectroniques. Le Dr Reddy, actuellement Directeur des Services d'Arythmies Cardiaques au Mount Sinai, dirigera l'exécution de l'étude pivotale mondiale BACKBEAT, qui évalue l'efficacité et la sécurité de la thérapie de modulation de l'intervalle atrioventriculaire (AVIM) pour les patients souffrant d'hypertension non contrôlée et d'indication de stimulateur cardiaque.
La thérapie AVIM représente un traitement potentiel pour l'hypertension qui est toujours actif et réglable, sans dépendre de l'adhésion du patient. Le Dr Reddy se concentrera sur l'achèvement de l'étude BACKBEAT et sur la coordination des efforts entre les conseillers cliniques afin de réaliser le potentiel de la thérapie AVIM pour les populations hypertendues présentant un risque cardiovasculaire accru. L'entreprise explore également des applications thérapeutiques supplémentaires pour cette technologie.
Orchestra BioMed Holdings (Nasdaq: OBIO) hat Dr. Vivek Reddy zum Executive Chairman des BACKBEAT-Studienlenkungsausschusses und zum Vorsitzenden seines wissenschaftlichen Beirats für bioelektronische Therapien ernannt. Dr. Reddy, der derzeit Direktor für Herzrhythmusstörungen am Mount Sinai ist, wird die Durchführung der globalen Hauptstudie BACKBEAT leiten, die die Wirksamkeit und Sicherheit der Therapie zur Modulation des atrioventrikulären Intervalls (AVIM) bei Patienten mit unkontrollierter Hypertonie und Indikation für einen Herzschrittmacher bewertet.
Die AVIM-Therapie stellt eine potenzielle, immer aktive, anpassbare Behandlung für Hypertonie dar, die nicht von der Einhaltung der Patienten abhängt. Dr. Reddy wird sich darauf konzentrieren, die BACKBEAT-Studie abzuschließen und die Bemühungen unter den klinischen Beratern zu koordinieren, um das Potenzial der AVIM-Therapie für hypertensive Populationen mit erhöhtem kardiovaskulärem Risiko zu realisieren. Das Unternehmen untersucht auch zusätzliche therapeutische Anwendungen für diese Technologie.
- Partnership with Medtronic for potential worldwide distribution of AVIM therapy
- Appointment of highly credentialed medical expert Dr. Reddy to lead clinical development
- Ongoing development of additional therapeutic applications beyond hypertension
- BACKBEAT study still in enrollment phase, efficacy not yet proven
- Technology to patients who already need pacemakers
- The BACKBEAT global pivotal study is currently enrolling patients to evaluate the efficacy and safety of atrioventricular interval modulation (“AVIM”) therapy for patients who have uncontrolled hypertension and a pacemaker indication
- A globally recognized thought leader and innovator in cardiovascular technologies, including electrophysiology and cardiac rhythm management, Dr. Reddy currently serves as the Director of Cardiac Arrhythmia Services at The Mount Sinai Fuster Heart Hospital, the Director of Electrophysiology for the Mount Sinai Health System, and the Leona M. and Harry B. Helmsley Charitable Trust Professor of Medicine in Cardiac Electrophysiology at the Icahn School of Medicine at Mount Sinai
NEW HOPE, Pa., Feb. 18, 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 the appointment of Vivek Reddy, M.D., as Executive Chairman of the Company’s BACKBEAT Study Steering Committee and Chairman of its Bioelectronic Therapies Scientific Advisory Board. In these roles, Dr. Reddy will provide critical leadership in continuing to execute the BACKBEAT global pivotal study and further develop scientific evidence and clinical value for the Company’s bioelectronic therapies portfolio.
Dr. Reddy commented, “I believe strongly in the transformative potential of AVIM therapy to help address uncontrolled hypertension in populations with increased cardiovascular risk such as the pacemaker-indicated patients we are focusing on in the BACKBEAT study. Hypertension is a critical global health challenge affecting hundreds of millions of patients worldwide. For patients with increased cardiovascular risk, the prospect of integrating an always-on, adjustable hypertension treatment that doesn’t rely on patient adherence is truly exciting. I am dedicated to driving the successful completion of the BACKBEAT study and synchronizing efforts among Orchestra BioMed’s clinical advisors to fully realize the potential of AVIM therapy for hypertension populations with increased cardiovascular risk. I’m also excited about exploring other therapeutic applications for which we believe there is potential utility for this novel technology.”
“We are thrilled to have Dr. Vivek Reddy assume these key leadership roles to help drive successful completion of the BACKBEAT global pivotal study and maximize the clinical value AVIM therapy can potentially offer to patients with uncontrolled hypertension worldwide,” said David Hochman, Chairman, Chief Executive Officer, and Founder of Orchestra BioMed. “While Dr. Reddy has been a long-standing advisor to this exciting program, his expanded role will allow him to further engage in establishing awareness of AVIM therapy in the clinical community and drive effective communication across our distinguished team of clinical advisors. We believe his leadership will be instrumental in educating the clinical community about the BACKBEAT study and AVIM therapy, ultimately helping us and our colleagues at Medtronic deliver this exciting device-based treatment option to patients worldwide. We also look forward to collaborating closely with Dr. Reddy as we continue research and development of our proprietary bioelectronic therapies for additional indications such as heart failure.”
Dr. Reddy currently serves as the Director of Cardiac Arrhythmia Services at The Mount Sinai Fuster Heart Hospital, the Director of Electrophysiology for the Mount Sinai Health System, and the Leona M. and Harry B. Helmsley Charitable Trust Professor of Medicine in Cardiac Electrophysiology at the Icahn School of Medicine at Mount Sinai. Dr. Reddy has led groundbreaking work in catheter ablation for atrial fibrillation and ventricular tachycardia, as well as leadless pacing and has been at the forefront of device therapies for stroke prevention, positioning him as one of the most respected experts in electrophysiology. Under his leadership, Mount Sinai has served as the lead investigational site for many pioneering clinical trials, and in 2014 implanted the world’s first leadless pacemaker. Dr. Reddy’s commitment to advancing medical innovation and his track record in clinical study leadership will play a pivotal role in the continued success of Orchestra BioMed’s efforts to revolutionize device-based cardiovascular solutions.
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 for the treatment of hypertension, a significant risk factor for death worldwide. Orchestra BioMed is also developing 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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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 potential efficacy and safety of the Company’s commercial product candidates, additional indications of the Company’s proprietary bioelectronic therapies, implementation of the Company’s ongoing BACKBEAT global pivotal study, the ability of the Company’s partnerships to accelerate clinical development, and the Company’s late-stage development programs, strategic partnerships and plans to expand its product pipeline. 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 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, 2023, which was filed with the U.S. Securities and Exchange Commission on March 27, 2024, as updated by any risk factors disclosed under the heading “Item 1A. Risk Factors” in the Company’s subsequently filed quarterly reports on Form 10-Q.
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Investor Contact
Silas Newcomb
Orchestra BioMed
(908) 723-4489
Snewcomb@orchestrabiomed.com
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FAQ
What is the BACKBEAT study testing for OBIO's AVIM therapy?
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