Orchestra BioMed's AVIM Therapy Holds 137 Patents for Hypertension and Heart Failure Treatment

Orchestra BioMed Holdings, Inc., a biomedical innovation firm listed on Nasdaq under the ticker OBIO, has significantly expanded its global intellectual property portfolio. The company, which focuses on accelerating impactful technologies to patients through strategic partnerships, announced the acquisition of 10 new patents in the past year for hypertension treatment. This achievement brings their total patent count for this condition to 120 worldwide.

Furthermore, Orchestra BioMed's atrioventricular interval modulation (AVIM) therapy, previously known as Cardiac Neuromodulation Therapy, has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA). This designation is for its potential use in treating uncontrolled hypertension in patients at increased cardiovascular risk, including those at risk of heart failure. The AVIM therapy now boasts a robust patent estate consisting of 46 patents in the United States and 91 internationally, collectively covering over 2,100 claims related to treating hypertension and heart failure.

The heart failure pipeline program of the company has also been bolstered by 17 new global patents. This growth in intellectual property underscores Orchestra BioMed's commitment to protecting and advancing their proprietary AVIM therapy platform, which aims to address the significant health challenges posed by hypertension and heart failure. These conditions are leading global health risks, with hypertension being the top risk factor for mortality, while heart failure affects over 64 million individuals worldwide.

David Hochman, Chairman and CEO of Orchestra BioMed, expressed pride in the expansion of the company's intellectual property assets. He emphasized the strategic importance of securing a comprehensive patent portfolio to support the company's innovative device-based therapies, which have the potential to enhance treatment options for hypertension and heart failure.

The AVIM therapy is currently undergoing evaluation in the BACKBEAT global pivotal study. This research focuses on patients with uncontrolled hypertension who are eligible for pacemaker treatment. These individuals represent a broader demographic of people with high blood pressure, who face an elevated risk of severe cardiovascular events such as myocardial infarction, stroke, and heart failure. The recent FDA Breakthrough Device Designation allows for expedited regulatory review and potential market access, underscoring the therapy's promising role in cardiovascular care.

Orchestra BioMed's strategic partnerships play a pivotal role in advancing its technologies. The company collaborates with Medtronic, one of the largest medical device firms globally, for the development and commercialization of AVIM therapy for hypertension treatment in pacemaker-indicated patients. Additionally, a partnership with Terumo, a leader in medical technology, focuses on the Virtue Sirolimus AngioInfusion Balloon (SAB) for treating atherosclerotic artery disease, a leading cause of death worldwide. The company's innovative approach has earned it four Breakthrough Device Designations from the FDA, highlighting the significant potential of its technologies to meet unmet needs in cardiovascular care.

Overall, Orchestra BioMed's recent developments in intellectual property expansion, strategic partnerships, and regulatory advancements position the company as a leader in biomedical innovation, with a focus on delivering high-impact technologies to patients worldwide.