Orchestra BioMed Announces AVIM Therapy Global Intellectual Property Estate Reaches 110 Issued Patents

• Patent estate covering atrioventricular interval modulation (“AVIM”) therapy includes 37 issued U.S. patents and 73 patents outside the U.S. that collectively comprise over 1,800 claims related to the treatment of hypertension
  
• AVIM therapy is currently being studied in the BACKBEAT global pivotal study in collaboration with Medtronic
• Orchestra BioMed to provide detailed overview of AVIM therapy and the BACKBEAT global pivotal study in upcoming R&D day on June 11, 2024 in New York City
  

NEW HOPE, Pa., April 30, 2024 (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 patent estate related to AVIM Therapy has reached 110 patents worldwide. The most recent patent was issued today, April 30, 2024.

“We are very proud of the extensive intellectual property portfolio we have amassed related to our lead program, AVIM therapy, which we’re actively evaluating for the treatment of hypertension in pacemaker-indicated patients in the BACKBEAT global pivotal study alongside our colleagues at Medtronic,” commented David Hochman, chief executive officer, chairman and founder of Orchestra Biomed. “We have vigorously pursued strong IP protection for AVIM therapy and continue to enhance the portfolio with 15 new patents granted for the treatment of hypertension since becoming a public company in January 2023. The depth and breadth of this patent estate represent the culmination of over a decade of work to bring a truly innovative therapeutic option to patients who deserve improved clinical outcomes and reflects an essential element of the value Orchestra BioMed provides in our strategic collaboration with Medtronic.”

The Orchestra BioMed global intellectual property portfolio related to the treatment of hypertension with AVIM therapy includes patent protection in key markets, including the U.S., Europe, Japan, and China. The Company owns additional issued patents related to Cardiac Neuromodulation Therapy (“CNT”) for other clinical indications and expects further patents to be granted related to AVIM therapy and CNT in the future.

About AVIM Therapy (BackBeat CNT)

AVIM therapy, also known as BackBeat CNT, 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. The global IDE pivotal BACKBEAT (BradycArdia paCemaKer with atrioventricular interval modulation for Blood prEssure treAtmenT) study will further evaluate the safety and efficacy of AVIM therapy in lowering blood pressure in a similar target population of patients who have been indicated for, and recently implanted with, a dual-chamber cardiac pacemaker.