CE Mark for Orchestra BioMed BackBeat Cardiac Neuromodulation Therapy™ for Hypertension

Orchestra BioMed™, Inc., tells us it has received CE Mark approval for its Moderato® implantable pulse generator system that delivers BackBeat Cardiac Neuromodulation Therapy™ (CNT) for treatment of hypertension while also providing standard pacemaker functions.


Orchestra BioMed™ describes itself as a biomedical innovation company providing high-impact solutions for large unmet needs in procedure-based medicine. Its BackBeat CNT 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 may be applicable to a wide range of hypertensive patients, including patients with isolated systolic disease and patients with uncontrolled hypertension despite multi-drug medical management.

The Cardiovascular Research Foundation (CRF) has selected Orchestra BioMed’s MODERATO II clinical study of BackBeat CNT for a late-breaking science presentation at the Transcatheter Cardiovascular Therapeutics (TCT) 2019 annual conference on September 28, 2019. The presentation titled, “MODERATO II: A Double-Blind Randomized Trial of Cardiac Neuromodulation Therapy in Patients with Hypertension,” will be presented by Karl-Heinz Kuck, MD., Ph.D., director of cardiology at the Lans Medicum, Hamburg, Germany and principal investigator for the MODERATO Studies. The MODERATO II results will also be highlighted at a press conference to be held at TCT during the morning of September 28, 2019. Every year, TCT late-breaking presentations feature major medical research breakthroughs and highlight the latest data on the most innovative treatments that will impact patient care and how physicians treat heart disease. The studies selected examine the safety and efficacy of minimally invasive techniques, pharmaceuticals, therapies and devices that demonstrate potential to treat or prevent cardiovascular disease.

Investigator comments

“BackBeat CNT is an exciting new approach to device-based blood pressure management and has potential to be a primary treatment modality for the more than two-thirds of pacemaker patients at risk from hypertension,” said Dr. Karl-Heinz Kuck. “In the MODERATO I clinical trial, BackBeat CNT demonstrated excellent efficacy and safety results, particularly given that 78% of the study patients had isolated systolic hypertension and that patients’ average baseline ambulatory systolic blood pressure (137 mmHg) was lower compared to patients in other device-based hypertension studies. I look forward to presenting the six-month primary endpoint results from the MODERATO II study of BackBeat CNT as a late-breaker at TCT later this month.”

Company comments

“CE Mark approval and selection for late-breaking science presentation at TCT validate the potential for BackBeat CNT to benefit targeted high-risk hypertensive patients, such as those already indicated for a pacemaker,” said David Hochman, Chairman and CEO of Orchestra BioMed. “Effective treatment of these patients, the majority of whom have isolated systolic disease and persistent high blood pressure despite conventional pharmaceutical therapies, represents a significant market opportunity that could have substantial growth, value and market share implications for the field of cardiac rhythm management.”

Source: Orchestra BioMed, Inc.

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