Orchestra BioMed’s AVIM Therapy Global Intellectual Property Estate Reaches 137 Issued Patents for the Treatment of Hypertension and Heart Failure
Orchestra BioMed (NASDAQ: OBIO) has significantly expanded its intellectual property portfolio for AVIM therapy, securing 10 new patents for hypertension treatment in the past 12 months. The company's global patent estate now totals 137 issued patents, including 120 patents for hypertension and 17 for heart failure treatment, comprising over 2,100 claims. The portfolio includes 46 U.S. patents and 91 international patents across key markets including Europe, Japan, and China.
AVIM therapy recently received FDA Breakthrough Device Designation for treating uncontrolled hypertension in high-risk cardiovascular patients. The therapy is currently being evaluated in the BACKBEAT global pivotal study for treating uncontrolled hypertension in patients with pacemaker indications, targeting a condition that is the leading global risk factor for death and affects millions worldwide.
Orchestra BioMed (NASDAQ: OBIO) ha ampliato significativamente il suo portafoglio di proprietà intellettuale per la terapia AVIM, ottenendo 10 nuovi brevetti per il trattamento dell'ipertensione negli ultimi 12 mesi. Il patrimonio globale di brevetti dell'azienda conta ora 137 brevetti concessi, di cui 120 per l'ipertensione e 17 per il trattamento dell'insufficienza cardiaca, con oltre 2.100 rivendicazioni. Il portafoglio comprende 46 brevetti negli Stati Uniti e 91 brevetti internazionali nei principali mercati, tra cui Europa, Giappone e Cina.
La terapia AVIM ha recentemente ricevuto la designazione FDA Breakthrough Device per il trattamento dell'ipertensione non controllata in pazienti cardiovascolari ad alto rischio. Attualmente, la terapia è oggetto di valutazione nello studio globale pivotale BACKBEAT per il trattamento dell'ipertensione non controllata in pazienti con indicazioni per pacemaker, puntando a una condizione che rappresenta il principale fattore di rischio globale di mortalità e colpisce milioni di persone in tutto il mondo.
Orchestra BioMed (NASDAQ: OBIO) ha ampliado significativamente su cartera de propiedad intelectual para la terapia AVIM, asegurando 10 nuevas patentes para el tratamiento de la hipertensión en los últimos 12 meses. La cartera global de patentes de la compañía ahora suma 137 patentes otorgadas, incluyendo 120 patentes para hipertensión y 17 para el tratamiento de insuficiencia cardíaca, con más de 2,100 reivindicaciones. La cartera incluye 46 patentes en EE.UU. y 91 patentes internacionales en mercados clave como Europa, Japón y China.
La terapia AVIM recibió recientemente la designación FDA Breakthrough Device para el tratamiento de la hipertensión no controlada en pacientes cardiovasculares de alto riesgo. Actualmente, la terapia está siendo evaluada en el estudio global pivotal BACKBEAT para tratar la hipertensión no controlada en pacientes con indicaciones para marcapasos, enfocándose en una condición que es el principal factor de riesgo global de muerte y afecta a millones en todo el mundo.
Orchestra BioMed (NASDAQ: OBIO)는 AVIM 치료법에 대한 지적 재산권 포트폴리오를 크게 확장하여 지난 12개월 동안 고혈압 치료를 위한 10건의 신규 특허를 확보했습니다. 회사의 글로벌 특허 보유 건수는 현재 137건의 등록 특허로, 고혈압 관련 특허 120건과 심부전 치료 관련 17건을 포함하며 2,100건 이상의 청구항으로 구성되어 있습니다. 이 포트폴리오에는 미국 특허 46건과 유럽, 일본, 중국 등 주요 시장의 국제 특허 91건이 포함되어 있습니다.
AVIM 치료법은 최근 고위험 심혈관 환자의 조절되지 않는 고혈압 치료를 위해 FDA 혁신 의료기기 지정(Breakthrough Device Designation)을 받았습니다. 현재 이 치료법은 페이스메이커 적응증 환자의 조절되지 않는 고혈압 치료를 위한 글로벌 주요 임상시험 BACKBEAT에서 평가 중이며, 이는 전 세계적으로 사망 위험 요인 1위인 질환으로 수백만 명에게 영향을 미치고 있습니다.
Orchestra BioMed (NASDAQ : OBIO) a considérablement élargi son portefeuille de propriété intellectuelle pour la thérapie AVIM, obtenant 10 nouveaux brevets pour le traitement de l'hypertension au cours des 12 derniers mois. Le portefeuille mondial de brevets de la société compte désormais 137 brevets délivrés, dont 120 pour l'hypertension et 17 pour le traitement de l'insuffisance cardiaque, comprenant plus de 2 100 revendications. Le portefeuille inclut 46 brevets américains et 91 brevets internationaux sur des marchés clés tels que l'Europe, le Japon et la Chine.
La thérapie AVIM a récemment reçu la désignation FDA Breakthrough Device pour le traitement de l'hypertension non contrôlée chez les patients cardiovasculaires à haut risque. Cette thérapie est actuellement évaluée dans l'étude pivot mondiale BACKBEAT pour le traitement de l'hypertension non contrôlée chez les patients nécessitant un stimulateur cardiaque, ciblant une condition qui est le principal facteur de risque mondial de mortalité et qui touche des millions de personnes à travers le monde.
Orchestra BioMed (NASDAQ: OBIO) hat sein geistiges Eigentumsportfolio für die AVIM-Therapie erheblich erweitert und in den letzten 12 Monaten 10 neue Patente zur Behandlung von Bluthochdruck gesichert. Der globale Patentschutz des Unternehmens umfasst nun insgesamt 137 erteilte Patente, darunter 120 Patente für Bluthochdruck und 17 für die Behandlung von Herzinsuffizienz, mit über 2.100 Ansprüchen. Das Portfolio beinhaltet 46 US-Patente und 91 internationale Patente in wichtigen Märkten wie Europa, Japan und China.
Die AVIM-Therapie erhielt kürzlich die FDA Breakthrough Device Designation für die Behandlung von unbehandeltem Bluthochdruck bei Hochrisiko-Patienten mit Herz-Kreislauf-Erkrankungen. Die Therapie wird derzeit in der globalen Schlüsselstudie BACKBEAT zur Behandlung von unbehandeltem Bluthochdruck bei Patienten mit Indikation für einen Herzschrittmacher geprüft, wobei eine Erkrankung adressiert wird, die weltweit der führende Risikofaktor für Todesfälle ist und Millionen Menschen betrifft.
- Secured 10 new patents for hypertension treatment in last 12 months
- Obtained FDA Breakthrough Device Designation for AVIM therapy
- Strong global patent protection with 137 total patents across key markets
- Expanded intellectual property coverage to include heart failure treatment with 17 patents
- None.
Insights
Orchestra BioMed strengthens competitive position with 137 patents for AVIM therapy and FDA Breakthrough Designation for hypertension treatment.
Orchestra BioMed's expanded intellectual property portfolio represents a significant strengthening of their competitive position in the cardiovascular therapeutic space. The addition of 10 new patents for hypertension treatment in the past year, bringing their total to 120 patents specifically for this indication, demonstrates a robust strategy to protect their proprietary AVIM therapy technology. The expansion into heart failure applications with 17 issued patents indicates strategic diversification of potential therapeutic applications.
The FDA Breakthrough Device Designation for AVIM therapy in uncontrolled hypertension patients with increased cardiovascular risk is particularly noteworthy. This designation can accelerate the regulatory pathway and potentially expedite market access, while also providing external validation from regulators about the technology's potential clinical impact.
With 46 U.S. patents and 91 international patents containing over 2,100 claims, the company has built formidable barriers to competition. The strategic patent coverage across key markets (US, Europe, Japan, China) positions them well globally for both hypertension and heart failure applications - addressing hypertension as the leading global risk factor for death and heart failure affecting over 64 million people worldwide.
The ongoing BACKBEAT global pivotal study represents the critical clinical validation step before potential commercialization. Their collaboration with Medtronic enhances credibility and provides a potential commercialization pathway if clinical trials demonstrate efficacy. This combined approach of expanding patent protection while simultaneously advancing clinical development shows a comprehensive strategy to maximize the potential of their AVIM therapy platform.
- Secured ten new fully-issued patents related to hypertension treatment during last 12 months, bringing global issued patent estate total for this condition to 120 patents
- Patent estate covering atrioventricular interval modulation (“AVIM”) therapy now includes 46 issued U.S. patents and 91 patents outside the U.S. that collectively comprise over 2100 claims related to the treatment of hypertension as well as heart failure
- Heart failure pipeline program now protected by an additional 17 issued global patents
- FDA recently granted Breakthrough Device Designation to AVIM therapy for use in patients with uncontrolled hypertension at increased cardiovascular risk, including those at risk of heart failure
NEW HOPE, Pa., May 07, 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 continued expansion of its global intellectual property (IP) estate supporting its proprietary AVIM therapy pipeline (formerly known as Cardiac Neuromodulation Therapy or “CNT”). Over the past 12 months, the Company has secured 10 new patents related to treatment of hypertension. The Company has also secured a total of 17 patents covering application of the technology for treatment of heart failure, significantly expanding the reach of its IP platform.
"We are very proud of the continued expansion of our intellectual property portfolio supporting AVIM therapy, which we are actively evaluating for the treatment of hypertension in the BACKBEAT global pivotal study in collaboration with Medtronic," commented David Hochman, Chairman and Chief Executive Officer of Orchestra BioMed. "Over the past year, we have strengthened our patent estate with ten newly issued patents covering the treatment of hypertension. Our issued hypertension-specific patent portfolio is now 120 patents strong and we expect it to continue to grow in the future. Equally exciting is our growing heart failure treatment patent estate which is now comprised of seventeen issued patents. This extraordinary array of intellectual property reflects our strategic commitment to protect our proprietary, high-impact device-based therapy which we believe can help physicians better address the needs of patients with hypertension, the leading global risk factor for death, as well as heart failure, which affects more than 64 million people worldwide."
AVIM therapy is currently being evaluated in the BACKBEAT global pivotal study for the treatment of uncontrolled hypertension in patients who have or are indicated to receive a pacemaker. This population reflects the broader population of people living with high blood pressure who are at elevated risk for severe cardiovascular events and comorbidities such as myocardial infarction, stroke and heart failure, underscoring the potential broader impact of AVIM therapy beyond blood pressure management. AVIM therapy was recently granted Breakthrough Device Designation by the U.S. Food and Drug Administration (“FDA”) for the treatment of uncontrolled hypertension with increased cardiovascular risk, regardless of an indication for a pacemaker to treat a cardiac rhythm disorder.
The Orchestra BioMed global intellectual property portfolio related to the treatment of hypertension and heart failure with AVIM therapy includes patent protection in key markets, including the United States, Europe, Japan, and China.
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, 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. The company has received four Breakthrough Device Designations from the U.S. FDA across these two core programs, reflecting the significant potential of its technologies to address high unmet needs in cardiovascular care. 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 expected coverage and future growth of the Company’s intellectual property portfolio, the potential efficacy, safety and commercial value of the Company’s commercial 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 receiving a Breakthrough Device Designation, including its ability to expedite FDA reviews and streamline reimbursement pathways, the ability of the Company’s partnerships to accelerate clinical development, and the Company’s strategic partnerships. 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, 2024, which was filed with the U.S. Securities and Exchange Commission on March 31, 2025, as updated by any risk factors disclosed under the heading “Item 1A. 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
Silas Newcomb
Orchestra BioMed
Snewcomb@orchestrabiomed.com
Media Contact
Kelsey Kirk-Ellis
Orchestra BioMed
Kkirkellis@orchestrabiomed.com
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