Orchestra BioMed™ Wins 2020 MedTech Breakthrough Award for BackBeat Cardiac Neuromodulation Therapy™ Innovation

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Annual Awards Program Honors Outstanding Health & Medical Technology Products and Companies

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Orchestra BioMed’s patented implantable cardiac stimulation-based treatment embodies the spirit of the MedTech Breakthrough Awards program, representing innovation with significant implications for the field of cardiac rhythm management

MedTech Breakthrough, an independent market intelligence organization that recognizes the top companies, technologies and products in the global health and medical technology market, today announced that Orchestra BioMed, Inc. (“Orchestra BioMed” or the “Company”), a biomedical innovation company developing transformative therapeutic products for large unmet needs in procedure-based medicine, has been selected as the winner of the “Best New Therapeutic Technology Award” for the Company’s BackBeat Cardiac Neuromodulation Therapy (CNT) in the fourth annual MedTech Breakthrough Awards program.

BackBeat CNT™ is a patented bioelectronic treatment that delivers an immediate, substantial and sustained reduction in blood pressure while simultaneously modulating the autonomic nervous system. Results from MODERATO II, the prospective, randomized, double-blind, multicenter study demonstrated that BackBeat CNT drove a statistically significant and clinically meaningful reduction in 24-hour ambulatory systolic blood pressure (ASBP) versus control in hypertensive patients who are also indicated for a pacemaker.

“With high blood pressure affecting approximately 1 out of 3 Americans, BackBeat CNT is a much needed “breakthrough” approach to device-based blood pressure management,” said James Johnson, managing director, MedTech Breakthrough. “Orchestra BioMed’s patented implantable cardiac stimulation-based treatment embodies the spirit of the MedTech Breakthrough Awards program, representing innovation with significant implications for the field of cardiac rhythm management. We are thrilled to recognize Orchestra BioMed for their well-deserved success and innovation with BackBeat CNT.”

Hypertension (elevated blood pressure) is a condition that increases the risk of major cardiac events such as heart attack and stroke and can also contribute to other significant conditions such as heart failure and kidney disease. According to the World Health Organization (WHO), hypertension is the leading global risk factor for death and it is estimated to afflict 1.13 billion adults worldwide. In the United States, 116.4 million adults, or approximately 46% of all adults, are estimated to have hypertension, according to the American Heart Association.

BackBeat CNT mimics the effects of multi-drug hypertension therapy by targeting preload, afterload and sympathetic tone. Orchestra BioMed’s CE Mark-approved Moderato® implantable pulse generator system delivers BackBeat CNT while also providing standard pacemaker functions. Over 1.1 million pacemakers are implanted annually worldwide and over 70% of pacemaker patients suffer from hypertension alongside other comorbidities and risk factors. Because BackBeat CNT can be readily incorporated into a standard pacemaker device without requiring a change to hardware or implantation technique, treatment of hypertensive patients also indicated for pacemaker is a compelling initial clinical application of this novel therapy.

“We are honored to receive industry recognition for our BackBeat CNT therapy,” said David Hochman, chairman, CEO and founder of Orchestra BioMed. “This award validates the potential therapeutic significance of our patented cardiac neuromodulation therapy for hypertensive patients and acknowledges our team’s ability to execute on our mission of bringing medical innovations to life. We look forward to continuing to advance the development of this exciting new therapy and forging strategic collaborations that enable it to reach patients worldwide.”

The mission of the MedTech Breakthrough Awards is to honor excellence and recognize the innovation, hard work and success in a range of health and medical technology categories, including Robotics, Clinical Administration, Telehealth, Patient Engagement, Electronic Health Records (EHR), mHealth, Medical Devices, Medical Data and many more. This year’s program attracted more than 3,750 nominations from over 15 different countries throughout the world.

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About MedTech Breakthrough
Part of Tech Breakthrough, a leading market intelligence and recognition platform for global technology innovation and leadership, the MedTech Breakthrough Awards program is an independent program devoted to honoring excellence in medical and health related technology companies, products, services and people. The MedTech Breakthrough Awards provide a platform for public recognition around the achievements of breakthrough health and medical companies and products in categories that include Patient Engagement, mHealth, Health & Fitness, Clinical Administration, Healthcare IoT, Medical Data, Healthcare Cybersecurity and more. For more information visit MedTechBreakthrough.com.

About Orchestra BioMed™
Orchestra BioMed is a biomedical innovation company focused on developing transformative therapeutic products for large unmet needs in procedure-based medicine. The Company is led by a highly accomplished, multidisciplinary management team and board of directors with extensive experience in all phases of medical device development. 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 was formed in 2018 by assembling a pipeline of multiple late-stage clinical product candidates originally developed by the Company’s founding team. The Company’s flagship product candidates are Virtue® Sirolimus AngioInfusion™ Balloon (SAB) for the treatment of artery disease, the leading cause of mortality, and BackBeat Cardiac Neuromodulation Therapy™ for the treatment of hypertension, the leading risk factor for death worldwide. Orchestra BioMed has a global strategic partnership with Terumo Corporation, one of the world’s largest medical device companies, for development and commercialization of Virtue SAB. Together, the companies plan to initiate a U.S. pivotal trial for the use of Virtue SAB in the treatment of coronary in-stent restenosis in 2020 which will be the first in a series of pivotal trials aimed at achieving regulatory approvals in multiple indications worldwide. The Company has additional product candidates in its pipeline and plans to thoughtfully expand its product pipeline in the future through acquisitions, strategic collaborations, licensing and organic development.

About BackBeat CNT™
BackBeat CNT, a flagship therapy of Orchestra BioMed, is a bioelectronic treatment that immediately, substantially, and chronically lowers blood pressure (BP) while simultaneously modulating the Autonomic Nervous System (ANS). Orchestra BioMed’s CE Mark-approved Moderato® implantable pulse generator system delivers BackBeat CNT while also providing standard pacemaker functions. BackBeat CNT mimics the effects of multi-drug hypertension therapy by targeting preload, afterload and sympathetic tone. BackBeat CNT’s initial target are patients with uncontrolled hypertension who are also indicated for a pacemaker.

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