Orchestra developed BackBeat CNT as a bioelectronic treatment to lower the blood pressure and modulate the Autonomic Nervous System (ANS)
US-based biomedical company Orchestra BioMed has received CE Mark approval for its Moderato implantable pulse generator system to deliver BackBeat Cardiac Neuromodulation Therapy (CNT) for treatment of hypertension and offer standard pacemaker functions.
Orchestra BioMed has organically developed its product pipeline, featuring Virtue Sirolimus-Eluting Balloon (SEB) for the treatment of artery disease, and BackBeat CNT for the treatment of hypertension.
The company has a global strategic partnership with Terumo Corporation, one of the world’s largest medical device companies, for the development and commercialization of Virtue SEB.
Orchestra BioMed chairman and CEO David Hochman said: “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.”
Orchestra provides high-impact solutions for large unmet needs in procedure-based medicine
Orchestra has developed its BackBeat CNT as a bioelectronic treatment to substantially lower the blood pressure (BP) and simultaneously modulate the Autonomic Nervous System (ANS).
BackBeat CNT imitates the effects of multi-drug hypertension therapy by targeting preload, afterload and sympathetic tone.
According to the company, it may be applicable to a broad range of hypertensive patients, including those with isolated systolic disease and uncontrolled hypertension despite multi-drug medical management.
Lans Medicum cardiology director and MODERATO Studies principal investigator Karl-Heinz Kuck said: “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.”