BackBeat CNT

Orchestra BioMed has received CE mark approval for its Moderato implantable pulse generator system that is designed to deliver BackBeat Cardiac Neuromodulation Therapy for the treatment of hypertension while also providing standard pacemaker functions. Additionally, the Cardiovascular Research Foundation (CRF) has selected the MODERATO II clinical study, which evaluated BackBeat CNT, to be presented during a late-breaking science session at the 2019 Transcatheter Cardiovascular Therapeutics (TCT) meeting (25–29 September, San Francisco, USA).

BackBeat CNT is a bioelectronic treatment that aims to immediately, substantially and chronically lowers blood pressure while simultaneously modulating the autonomic nervous system. The now CE-marked approved Moderato implantable pulse generator system delivers BackBeat CNT while also providing standard pacemaker functions. BackBeat CNT is designed to mimic the effects of multidrug 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.

David Hochman, chairman and CEO of Orchestra BioMed, 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. 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.”

The principal investigator of MODERATO II Karl-Heinz Kuck (Lans Medicum, Hamburg, Germany) will present the study at TCT 2019; the study will also feature in a TCT press conference. A press release reports that 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.

Kuck 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. 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.”