Orchestra BioMed Holdings, Inc. announced the presentation of new clinical data from a pressure-volume (PV) loop study of atrioventricular interval modulation (AVIM) therapy (also known as BackBeat CNT?) in pacemaker-indicated patients with uncontrolled hypertension despite the use of antihypertensive medication. These data demonstrate the favorable impact of AVIM therapy compared to standard right ventricular (RV) pacing on systolic blood pressure and overall cardiac function when delivered using both conduction system andstandard pacing lead locations. The PV loop study was conducted at Na Homolce Hospital in Prague by Prof. Petr Neu?il, M.D. and the data were featured in an oral presentation at the Technology and Heart Failure Therapeutics (THT) 2024 Meeting by Prof. Karl-Heinz Kuck, M.D., Medical Director at LANS Cardio Hamburg.

AVIM therapy is an investigational patented bioelectronic therapy, administered using a standard dual-chamber pacemaker, designed to immediately, substantially and persistently reduce blood pressure. Summary of the PV Loop Clinical Results Presented at THT 2024: Design: 16 patients indicated for a dual-chamber pacemaker who also had uncontrolled hypertension despite the use of antihypertensive medication underwent invasive PV loop testing to evaluate cardiac function, measured by changes in left ventricular (?LV?) volumes and pressures using a pressure-volume catheter placed in the LV; Systolic blood pressure (?SBP?) was measured using a pressure transducer placed in the aorta, and baseline measurements were recorded using atrial pacing at a fixed rate and normal conduction; AVIM therapy with pacing leads placed in standard RV locations (AVIM RV), as well as in conduction system pacing (AVIM CSP) locations targeting the left bundle branch area (LBBA) regions, respectively, was compared to standard AV sequential pacing (DDD mode pacing or ?AV Pacing?). Results: Overall mean results for each variable were calculated using paired measurements for each individual patient using AVIM RV, AVIM CSP and AV Pacing, respectively: AVIM therapy generated statistically significant reductions (p<0.05) in SBP, end diastolic volume (?EDV?), end diastolic pressure (?EDP?), and end systolic volume (?ESV?) using both AVIM RV and AVIM CSP pacing lead locations compared to AV Pacing: SBP was reduced by 17.1 mmHg and 19.2 mmHg compared to 1.6 mmHg; EDV was reduced by 12.6 mL and 18.6 mL compared to 1.4 mL; EDP was reduced by 2.3 mmHg and 3.6 mmHg compared to an increase of 0.3 mmHg; ESV was reduced by 11.0 mL and 14.1 mL compared to an increase of 1.8 mL.

AVIM therapy drove statistically significant (p<0.05) reductions in stroke work (SW) without significantly reducing stroke volume (SV) compared to AV Pacing: Stroke work (SW) was reduced by 1596 mL and 1870 mL compared to 42 mL; Stroke volume (SV) was not significantly reduced by AVIM RV, AVIM CSP or AV Pacing. AVIM therapy drove statistically significant (p<0.05)reductions in total peripheral resistance (?TPR?, measured by Ea) and no change in contractility (?Ees?) compared to AV Pacing: Effective arterial elastance (?Ea?, a measure of TPR) was reduced by 0.23 mmHg/mL and 0.31 mmHg/mL compared to an increase of 0.04 mmHg/mL; Ees remained unchanged with AVIM RV, AVIM CSP and AV Pacing. The company is actively enrolling patients in the BACKBEAT pivotal study, a global, multi-center, prospective, randomized, double-blind study investigating the efficacy and safety of AVIM therapy in patients who have recently undergone implantation of a Medtronic dual-chamber cardiac pacemaker and have uncontrolled hypertension despite the use of antihypertensive medications.

The study?s primary efficacy endpoint will determine at three months post-randomization whether AVIM-treated patients experience a statistically significant reduction in aSBP as compared to control patients.