Our Innovations

BackBeat CNT
™

(AVIM Therapy)

A patented, investigational bioelectronic treatment for hypertension

BackBeat Cardiac Neuromodulation Therapy™, also known as atrioventricular interval modulation (AVIM) therapy, is designed to substantially, immediately 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.

Patented Bioelectronic Therapy

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 with background antihypertension medications.

Leverages Standard Rhythm Management Devices

Designed to readily incorporate into existing devices and treatment pathways.

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.

Atrioventricular interval modulation (AVIM) therapy is supported by encouraging preclinical and clinical data. In MODERATO I and II pilot studies, the therapy demonstrated statistically significant reductions in blood pressure in patients with hypertension and an indication for a pacemaker.

Clinical

AVIM therapy showed promising results in MODERATO II, a prospective, multi-center, randomized, double-blind study of pacemaker patients with persistent hypertension including 88.5% with isolated systolic hypertension (ISH)^1,2

11.1↓

mmHg 24-Hour aSBP³ at 6 months

17.5↓

mmHg in oSBP³ at 2 years

0%

MACE³ at 6 months

85%

of patients with reduction in aSBP

Significant Reduction in 24-Hr aSBP and oSBP

Results were presented during the Breakthrough Science Session at TCT 2019

Data published in the American Heart Association journal

Significant Reduction in aSBP 24 Hours a Day

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.^6,7

10.1↓

mmHg 24-Hour aSBP at 3 months

13.1↓

mmHg in oSBP at 2 years

87.5%

of patients with reduction in aSBP

Significant Reduction in 24-Hr aSBP

Significant Reduction in oSBP Maintained Through 24 Months

Preclinical

Preclinical Delivery of AVIM therapy 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 its full duration.

Significantly Reduced Blood Pressure

*Data on file

¹Kalaras et al. Journal of the American Heart Association. 2021;10:e020492. https://doi.org/10.1161/JAHA.120.020492.

²Burkhoff MODERATO II Study 2-Year Results TCT 2021.

³Ambulatory systolic blood pressure (aSBP), office systolic blood pressure (oSBP) and Major Cardiac Advance Events (MACE), including 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.

⁴Compared to pre-activation.

⁵24-Hr aSBP Control (n=19). 1 control patient could not be measured despite repeat measurement (patient had extremely high blood pressure)

⁶Neuzil et al. Journal of the American Heart Association. 2017;6:e006974. https://doi.org/10.1161/JAHA.117.006974.

⁷Burkhoff MODERATO I Study 2-Year Results TCT 2018.

⁸Compared to pre-activation.

⁹16 patients had aSBP at pre-activation.

¹⁰21 of 27 patients continued after completion of study at 3 months to be followed for 2 years

Orchestra BioMed entered into a global strategic collaboration with Medtronic to develop AVIM therapy as a bioelectronic treatment for hypertension in patients indicated for a cardiac pacemaker.

"As the global leader in advanced cardiac pacing therapies, Medtronic is the ideal partner to help us develop AVIM therapy 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."

David Hochman,
Chairman, CEO and Founder, Orchestra BioMed

About the Agreement

Orchestra BioMed will conduct a global pivotal trial to further evaluate the safety and efficacy of AVIM therapy in lowering blood pressure in patients who have been indicated for and recently received a cardiac pacemaker implant
Medtronic will provide Orchestra BioMed with development, clinical and regulatory support for the multi-national pivotal study
Medtronic will have the global rights to commercialize AVIM therapy for this target population following regulatory approval
Orchestra BioMed will share in the revenues generated from Medtronic’s sale of AVIM therapy-enabled pacing systems

Disclaimer

BackBeat CNT ™ (AVIM Therapy)