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BaroPace Announces RelieveHFpEF-II, Its Phase I First-in-Human Trial of PressurePacetm, Its Patent-Pending Pacemaker Control Algorithm for the Treatment of Heart Failure with Preserved Ejection Fraction (HFpEF), Met All Primary and Secondary Endpoints

BaroPace Inc. announces its Phase I first-in-human trial of PressurePaceTM, its patent-pending pacemaker control algorithm for the treatment of heart failure with preserved ejection fraction (HFpEF), met both its primary endpoints of quality of life (Minnesota Living with Heart Failure Questionnaire) and exercise tolerance (Low Level Bruce Protocol Treadmill Exercise Test) and secondary endpoints of 6-Minute Walk Time, and NYHA Score compared to placebo (standard pacing). The PressurePaceTM system wirelessly links a pacemaker, a blood pressure cuff, and the PressurePaceTM algorithm, a real-time, closed-loop system of therapy for patients with HFpEF.

RelieveHFpEF-II was a 7-week trial conducted in India at four major medical centers using dual chamber pacemakers manufactured by Shree Pacetronix Ltd, India. After baseline assessments, sixteen patients were randomized to one of two three-week treatment arms: standard pacing, or BaroPacing utilizing the PressurePaceTM algorithm. Blood pressure was measured using 24-hour blood pressure monitoring at baseline, after each treatment arm, and twice daily in-home using a blood pressure cuff. Clinically important changes in blood pressure associated with BaroPacing were also noted, including a drop in systolic blood pressure in hypertensive patients to the range associated with optimal mortality rates, and an overall narrowing of pulse pressure, thought to be beneficial in heart failure. The average percentage of BaroPacing for the treatment arms' duration was 12% suggesting that inducing persistent elevation of heart rate in HFpEF patients who may also have coexistant cardiovascular disease is unnecessary. No adverse events were reported from PressurePaceTM therapy.

The results of the trial were presented at HRS 2024 in Boston. Two peer-reviewed manuscripts are in preparation. A US multicenter pivotal trial of PressurePaceTM in HFpEF, RelieveHFpEF-III, is in the planning stage. The RelieveHFpEF-III trial program will also include pilot first-in-human feasibility studies of PressurePaceTM in resistant hypertension, and will evaluate a state of the art medical grade wrist-worn cuffless blood pressure measuring device (CentrusDx SmartBand 1, from Centrus Diagnostics Inc.) as a method of blood pressure input to PressurePaceTM.

"We are deeply appreciative for the participation of the heart failure patients, medical centers, and clinical investigators in India," Michael Burnam, MD, FACP, FACC, CEO and founder of BaroPace commented. "A safe, effective treatment of HFpEF is a critical global unmet need. HFpEF is the most common form of heart failure worldwide and in most cases the result of treatment resistant hypertension. Although pharmacologic therapy may offer promise for the treatment of HFpEF, no device therapy is now available. PressurePaceTM is a safe, very well tolerated, easy to implement personalized therapy for HFpEF, a real-time, closed-loop system that is active only when required. The results of RelieveHFpEF-II are consistent with published retrospective (1) and short-term prospective clinical studies (2). We are excited to begin planning RelieveHFpEF-III, the US multi-center pivotal trial of PressurePaceTM in HFpEF patients that will study the safety and effectiveness of PressurePaceTM in a larger number of patients over a longer period of time and to begin evaluation of PressurePaceTM in resistant hypertension and its integration with a new cuffless blood pressure measurement device."

PressurePaceTM, BaroPacing, and the CentrusDx SmartBand 1 are not approved for sale in any market and are being evaluated in clinical studies.

(1) Nguyen, et al., 2024, Innovations in CRM

(2) Burnam et al., 2024, ESC Heart Failure

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