Orchestra BioMed Announces Peer-Reviewed Publication of MODERATO II Study Results

Orchestra BioMed

NEW HOPE, PA — Orchestra BioMed™, Inc. announced the publication of data from the double-blind, randomized MODERATO II study in the Journal of the American Heart Association (JAHA). The data demonstrated that BackBeat Cardiac Neuromodulation Therapy™ (CNT™), a programmable and adjustable bioelectronic therapy delivered via an active implantable cardiac pulse generator, significantly reduced 24-hour ambulatory systolic blood pressure (aSBP) in patients with persistent hypertension and a clinical indication for a pacemaker. The average age of the study population was 74 years, which is significantly older than patients generally enrolled in hypertension studies. There was also a higher prevalence of comorbid conditions in the study population and 81% of enrolled patients had isolated systolic hypertension (ISH), a more dangerous and difficult to treat form of hypertension that is predominant in older patients.

“We were very encouraged by the results of this double-blind, randomized study demonstrating meaningful and sustained reduction in aSBP out to six months in a very challenging hypertensive patient population,” said Karl-Heinz Kuck, M.D., Ph.D., director of cardiology at the Lans Medicum, Hamburg, Germany, and study principal investigator. “BackBeat CNT has a favorable risk benefit profile as the device is already required for rhythm management and MODERATO II data offers compelling preliminary evidence that this therapy may provide a safe and effective means to help patients with persistent hypertension and an indication for a pacemaker achieve target blood pressure levels and thereby reduce cardiovascular risk.”

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MODERATO II was a European prospective, multi-center, double-blind study investigating the efficacy of BackBeat CNT™ in patients with persistent hypertension (aSBP ≥130 mmHg and office systolic blood pressure (oSBP) ≥140 mmHg) despite one or more anti-hypertensive medications and an indication for implantation or replacement of a dual-chamber pacemaker. Following a 30-day run-in period during which patients received only standard pacing along with anti-hypertensive medications, 47 patients who met follow-up screening criteria for daytime aSBP were randomized to BackBeat CNT (n=26) or control (n=21) groups. Prior to randomization, the mean aSBP for both groups was 136.3 mmHg and patients had been treated with, on average, over three prescribed anti-hypertensive drugs. Key MODERATO II data from the JAHA publication include:

  • After six months, mean aSBP was reduced by 11.1 mmHg (p<0.001) in the BackBeat CNT group as compared to a reduction of 3.1 mmHg in the control group (p=0.17), for a net treatment effect of 8.1 mmHg (p=0.012).
  • The treatment group saw a very high (85%) overall response rate, with approximately 54% of the BackBeat CNT-treated patients experiencing a >10 mmHg aSBP reduction at six months, which is associated with a clinically meaningful reduction in risk of heart attack and stroke.
  • The BackBeat CNT group experienced a significantly greater reduction in oSBP compared to the control group, with a net treatment effect of 12.3 mmHg (p=0.02).
  • There were no major adverse cardiac events (MACE) in the BackBeat CNT group, and three events in two patients in the control group.
  • There were no significant differences in cardiac echo parameters between the BackBeat CNT and control groups.
  • Diastolic blood pressure and heart rate did not change between the BackBeat CNT and control groups during the study period, a notable finding given the high rate of ISH in the study population and the challenge to reduce systolic blood pressure without reduction of diastolic blood pressure in these patients.
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An editorial by two renowned physicians in the field of device-based hypertension treatment, Lucas Lauder, M.D. and Felix Mahfoud, M.D., was published along with the data. The editorial commended the study authors for conducting a randomized, sham-controlled, device-based hypertension trial and noted that “…although the baseline blood pressure was lower, the relative change in aSBP in the treatment group was larger than in other sham-controlled trials in device-based hypertension treatment.” The editorial further affirmed that MODERATO II data support BackBeat CNT as feasible and acceptably safe in the short term and noted that “…its efficacy in patients with isolated systolic hypertension, are to be highlighted.” The editorial can be accessed here.

Over 1.1 million pacemakers are implanted annually worldwide.1 Patients indicated for a pacemaker have a particularly high rate of elevated blood pressure with more than 70% of these patients suffering from hypertension.2 Based on data from the National Health and Nutrition Examination Survey (NHANES) III, it is estimated that the majority of hypertensive pacemaker patients suffer from ISH3, a particularly challenging form of hypertension to treat with no specific pharmaceutical therapy currently approved. Longer-term follow up results from the MODERATO II study presented at the American College of Cardiology conference in May 2021, but not included in JAHA publication, showed that BackBeat CNT reduced oSBP in treated ISH patients by an average of 16.4 mmHg after 18 months of treatment.

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1 BIS Research, 2017, Global Pacemaker and Implantable Cardioverter Defibrillators (ICDs) Market
2 Guha A, Xiang X, Haddad D, et al. Eleven-year trends of inpatient pacemaker implantation in patients diagnosed with sick sinus syndrome. J Cardiovasc Electrophysiol. 2017;28(8):933–943. doi:10.1111/jce.13248
3 SS Franklin et all. Hypertension. 2001 Mar;37(3):869-74

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