BackBeat Cardiac Neuromodulation Therapy™ is designed to immediately, substantially and persistently lower blood pressure.
Programmable and adjustable bioelectronic therapy designed to lower blood pressure while simultaneously modulating the autonomic nervous system (ANS).
Designed to leverage standard rhythm management device hardware, such as dual-chamber pacemaker, utilizing the same implant procedure and lead positions.
Designed to immediately, substantially and persistently lower blood pressure.
Designed to substantially lower blood pressure through programmed pacing.
Designed to maintain reduction by modulating autonomic nervous system (ANS) response through programmed variable pressure patterns.
Designed to work automatically without relying on patient compliance and with background antihypertension medications.
Designed to readily incorporate into existing devices and treatment pathway.
Can be readily incorporated into existing cardiac rhythm management devices such as pacemakers using standard implant and lead placement techniques.
Designed to be rapidly adaptable for hypertensive patients already indicated for a pacemaker.
BackBeat CNT™ is supported by encouraging preclinical and clinical data. It has demonstrated statistically significant reductions in blood pressure in patients with hypertension and an indication for a pacemaker in the MODERATO II pilot study.
Delivery of BackBeat CNT significantly reduced 24-hour systolic and diastolic blood pressures in a canine model. The reduction occurred immediately upon activation of therapy and was maintained for the period that the therapy was active.
Significantly Reduced Blood Pressure
*Data on file
BackBeat CNT has shown promising clinical performance in two pilot studies:
MODERATO I, an open-label, single-arm, multi-center, prospective study of 27 patients with persistent hypertension and an indication for a pacemaker demonstrated a substantial reduction in blood pressure sustained out to 2 years.
Results Sustained Out to 2 Years (MODERATO I)
MODERATO II, a prospective, multi-center, randomized, (BackBeat CNT + Medical Therapy vs. Continued Medical Therapy), double-blind, pilot study of pacemaker patients with persistent hypertension.
Between Groups Reduction in aSBP
Between Groups Reduction in oSBP
Significant Reduction in aSBP (mmHg) at 6 months†
Significant Reduction in oSBP (mmHg) at 6 Months††
†24-Hours aSBP (mmHg) at 6 months Post-Randomization vs. Week 3 Run-in.
††24-Hours oSBP (mmHg) at 6 Months Post-Randomization vs. Week 4 Run-In
*Major Cardiac Advance Events (MACE) included death, heart failure, clinically significant arrhythmias (i.e., persistent or increased atrial fibrillation, serious ventricular arrhythmias), myocardial infarction, stroke and renal failure in treatment group calculated per patient
**Responder rate: % of patients with reduction in aSBP in the treatment group
Orchestra BioMed entered into a global strategic collaboration with Medtronic to develop BackBeat CNT as a bioelectronic treatment for hypertension in patients indicated for cardiac pacemakers.
"As the global leader in advanced cardiac pacing therapies, Medtronic is the ideal partner to help us develop BackBeat CNT for the treatment of hypertension, which is remarkably common and drives significant health risk in the pacemaker population. This exemplifies our commitment to accelerating high-impact medical innovations with global medical technology leaders."
Chairman, CEO and Founder, Orchestra BioMed
About the Agreement
BackBeat CNT™ is not approved for commercial use in the US
© 2022 Orchestra BioMed Inc. Virtue®, BackBeat CNT™ FreeHold Duo®, FreeHold Trio® and Orchestra BioMed™ are trademarks of Orchestra BioMed.
All other trademarks are trademarks of their respective owners.
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