PressurePace™

A Medical Breakthrough in HFpEF

BaroPace is singularly focused on developing the first physiologic, device-based therapy for heart failure with preserved ejection fraction (HFpEF)—a condition affecting millions of patients worldwide for whom no disease-modifying treatment currently exists.

Our work is grounded in clinical evidence demonstrating that abnormal blood pressure regulation, rather than heart rate alone, is a key driver of exercise intolerance and symptoms in HFpEF. BaroPace was founded to restore normal cardiovascular physiology through blood pressure–regulated atrial pacing (BRT), delivered using standard dual-chamber pacemakers enhanced by our proprietary PressurePace™ algorithm.

Clinical Evidence and Progress

BaroPace’s development has progressed from early clinical observations to prospective, peer-reviewed human trials.

Initial retrospective clinical analyses, totaling more than 230 patients followed for up to six years, suggested that patients with HFpEF and pacemakers experienced improved outcomes when pacing strategies influenced blood pressure. These findings were presented at multiple international scientific meetings, including the Heart Rhythm Society (HRS), between 2019 and 2021, establishing the foundation for prospective clinical testing.

BaroPace then advanced to prospective human trials, culminating in the RelieveHFpEF clinical program conducted in India.

• RelieveHFpEF-I established first-in-human feasibility and physiologic proof of concept.
• RelieveHFpEF-II, completed in 2024, was a double-blind, crossover study in patients with HFpEF and dual-chamber pacemakers. The trial demonstrated improvements in exercise capacity, symptom burden, functional class, and blood pressure optimization, with zero adverse events.

RelieveHFpEF-II was pre-approved by Indian regulators, registered on ClinicalTrials.gov, and has now been published in ESC Heart Failure (European Society of Cardiology – Heart Failure), providing peer-reviewed validation of BaroPace’s therapeutic approach.

Using Blood Pressure to Treat HFpEF

Conventional pacemakers regulate heart rate using rate modulation, relying on motion and respiratory sensors that estimate activity but do not account for blood pressure or true hemodynamic demand. This approach is poorly suited to HFpEF, where inappropriate blood pressure responses during exertion limit cardiac performance and drive symptoms. PressurePace™ fundamentally changes this paradigm.

PressurePace™ ~ Proprietary Blood Pressure-Regulated Pacing

PressurePace™ is BaroPace’s proprietary closed-loop system that:

• Acquires blood pressure measurements from an external source (initially cuff-based)
• Integrates blood pressure data with pacemaker parameters using a secure computing platform
• Determines the optimal physiologic atrial pacing rate for each patient
• Communicates wirelessly with a standard dual-chamber pacemaker to implement pacing adjustments when indicated

This process restores normal atrial-driven cardiac physiology, rather than imposing non-physiologic rate acceleration. PressurePace™ also uniquely incorporates real-time patient feedback, allowing patients to report symptoms during therapy—creating, for the first time, a patient-interactive pacing system.

Key Innovations

PressurePace™ represents a number of potential “firsts”:

• The world’s first real-time closed-loop physiologic pacemaker control system.
• The world’s first real-time closed-loop physiologic control algorithm that remotely controls a pacemaker without the need for human intervention.
• The world’s first real-time closed-loop physiologic pacemaker control system that includes real-time patient interaction.
• The world’s first potential therapy for HFpEF and drug resistant hypertension based upon the restoration of normal physiology without the need for drugs, the induction of non-physiologic heart function, complex surgical procedures, or destruction of normal tissue.

Path Forward: Pivotal HFpEF Trial

With two successful prospective human trials completed and published, BaroPace is now preparing RelieveHFpEF-III, a pivotal clinical trial in India.

RelieveHFpEF-III is planned as a:

• 122-patient, randomized, double-blind study
• Six-month comparison of standard dual-chamber pacing versus PressurePace BRT
• Focused on patients with HFpEF associated with hypertension (the majority of HFpEF patients)

Preliminary planning is underway, with first patient enrollment targeted for July 2026, pending regulatory and site approvals.

Future Technology Evolution

In parallel, BaroPace is collaborating with Centrus Diagnostics to evaluate a cuffless, wearable blood pressure device as a future enhancement to PressurePace. While cuff-based measurements will be used for pivotal trials, wearable continuous blood pressure monitoring is envisioned as a next-generation platform to improve patient compliance and enable more frequent and exercise-based therapy.

Open-Loop Systems are NOT the Answer. Here’s Why.

Medical history repeatedly demonstrates that open-loop therapies, interventions applied without continuous physiologic feedback, often fail when treating complex, adaptive biological systems. Early successes may appear promising, but without real-time sensing and adjustment, these approaches frequently lead to incomplete efficacy, unintended consequences, or long-term harm.

Classic examples include surgical vagotomy for peptic ulcer disease, which initially reduced acid secretion but ultimately failed to address the dynamic regulation of gastric physiology, leading to recurrence, malnutrition, and complications once the true feedback-driven role of H. pylori and acid regulation became understood. Similarly, intestinal bypass procedures for obesity, designed as fixed anatomical solutions, produced dramatic early weight loss but were abandoned due to severe metabolic derangements, malabsorption, liver failure, and unanticipated long-term morbidity. In both cases, rigid interventions imposed on adaptive systems proved unsustainable.

In cardiovascular medicine, open-loop approaches have shown similar limitations. Fixed-rate pacemaker programming and sensor-based rate modulation estimate physiologic demand indirectly and fail to account for the moment-to-moment hemodynamic state of the patient—particularly blood pressure. This limitation is especially consequential in heart failure with preserved ejection fraction (HFpEF), where abnormal blood pressure responses, not heart rate deficiency alone, drive symptoms and exercise intolerance.

BaroPace was founded on the premise that restoring normal physiology requires closed-loop control. By continuously integrating blood pressure. the body’s primary hemodynamic signal into pacing decisions, PressurePace™ moves beyond static, open-loop interventions toward adaptive, patient-specific therapy. History teaches that durable medical solutions emerge not from forcing physiology, but from listening to it in real time.​

Video: Learn how PressurePace™ was used in the HFpEF-II Pivotal Clinical Trial

In RelieveHFpEF-II, blood pressure modulation was guided using a standard cuff-based measurement, as illustrated in the animation. In the pivotal RelieveHFpEF-III trial, cuff-based monitoring will again serve as the reference standard, while a predefined subset of patients will also be monitored using the CentrusDx cuffless blood-pressure system. This next evolution of PressurePace™ is designed to improve patient comfort and adherence, while enabling more frequent and physiologically responsive pacing—extending therapy beyond twice-daily resting measurements to multiple assessments per day, including during activity and exercise.

Visit CentrusDiagnostics.com and learn more about the CentrusDx cuffless blood pressure system.

Our Business Proposition

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