Orchestra BioMed Announces Clinical Data Demonstrating a Significant and Sustained Reduction in Blood Pressure in MODERATO II Control Patients After Crossover to BackBeat Cardiac Neuromodulation Therapy

Data Shows BackBeat CNT Reduces Blood Pressure in Crossover Hypertensive Patients

Orchestra BioMed, Inc., (“Orchestra BioMed” or the “Company”), a biomedical innovation company focused on developing transformative therapeutic products for large unmet medical needs in procedure-based medicine, today announced that long-term follow-up data on hypertensive patients from the control group of the MODERATO II study who received crossover treatment with BackBeat Cardiac Neuromodulation Therapy (CNT) were featured in a presentation at the Heart Rhythm Society meeting in Boston, MA on July 29th. The data demonstrated a clinically meaningful and statistically significant reduction in blood pressure in these patients, which was consistent with the decrease previously observed in the study’s treatment group during the same period.

“I continue to be impressed and encouraged by the observed reduction in blood pressure in patients treated with BackBeat CNT. Reductions in ambulatory and office systolic blood pressure were clinically significant and persistent in control patients who went on to receive crossover therapy,” stated Professor Zbigniew F. Kalarus, M.D., Ph.D., chairman of the department of cardiology at Silesian Center for Heart Diseases (SCHD), Zabrze, Poland. “Of additional importance is that the rate of adverse cardiac events in these patients was lower during the crossover period as compared to the control period, when patients were not receiving treatment with BackBeat CNT.”

MODERATO II is a European, prospective, multi-center, double-blind, randomized study of BackBeat CNT (n=26) vs. control (n=21) in patients with persistent hypertension (ASBP ≥130 mmHg and oSBP ≥ 140 mmHg) despite one or more anti-hypertensive medications and a pacemaker indication. Of the 21 control patients (treated with antihypertensive medications only, BackBeat not activated), 14 were eligible for crossover to BackBeat CNT, and 13 completed 12 months of follow-up to-date (one patient died of cancer). Key interim study data:

Immediately upon activation of BackBeat CNT, aSBP dropped by 16.7±12.9 mmHg (p<0.01) and remained low after 6 months (-10.3±9.3 mmHg, p<0.01); consistent with the decrease observed in the treatment group during the same time period.
After crossover to BackBeat treatment, oSBP decreased by 13.1±26.6 and 20.9±15.1 mmHg at 6 and 12 months, respectively (p=0.05).
A lower rate of adverse cardiac events was observed in the control patients during the crossover period as compared to the study control period when patients were not receiving BackBeat CNT.