About BaroPace™
Early 1800's
The important relationship between heart rate and blood pressure was identified by Jean Léonard Marie Poiseuille in the 19th century.
1932
The cardiac pacemaker was invented.
Today's Pacemakers
2019 | BaroPace™ is Established
Why is this important?
The discovery of a new pacemaker control paradigm, blood pressure-regulated therapy (BRT) leads to the development of the next generation of pacemaker control. Regulating pacemaker function to better mimic the body’s normal physiology, including real-time integration of blood pressure, will provide:
- A more physiologic pacemaker-mediated heart rate response at rest and with exercise for all patients with pacemakers.
- A new treatment option for HFpEF, the most common form of Heart Failure.
- May also form the basis for a new treatment for Drug Resistant Hypertension (DRH).
What is Heart Failure with Preserved Ejection Fraction (HFpEF)?
HFpEF is the most common type of Heart Failure. It occurs when heart muscle becomes excessively thickened and stiff preventing the heart from adequately filling and pumping blood. DRH is by far the most common cause. There are currently no proven therapies that prevent or improve HFpEF. (One class of drug in early clinical trials demonstrated a short-term reduction in symptoms.)
HFpEF by the Numbers
- Six million U.S. cases
- Five hundred thousand new U.S. cases annually
- Twenty-three million cases worldwide
- $30 billion in U.S. healthcare costs in 2017, projected $50 billion by 2030.
Drug Resistant Hypertension: A Related and Emerging Consideration
- Drug-resistant hypertension (DRH) refers to persistently elevated blood pressure despite treatment with multiple antihypertensive medications. It affects a substantial subset of patients with hypertension—estimated at millions in the U.S. and hundreds of millions worldwide—and is associated with significant healthcare utilization and cost.
- DRH is linked to an increased risk of heart attack, stroke, kidney disease, and mortality, and is frequently associated with pathologic left-ventricular thickening that contributes to heart failure with preserved ejection fraction (HFpEF).
- Because DRH reflects complex, adaptive dysregulation of blood pressure, many patients experience limited benefit from escalating pharmacologic therapy, highlighting the need for alternative physiologic approaches.
- While BaroPace’s current clinical and regulatory focus is on HFpEF, retrospective analyses and limited prospective experience suggest that blood pressure–regulated pacing may have relevance in selected patients with DRH. Further study is required before conclusions can be drawn.
- DRH therefore represents a potential future indication, complementary to BaroPace’s primary HFpEF strategy, pending additional clinical evidence.
Company Story
BaroPace was founded to address a fundamental and persistent gap in the treatment of heart failure with preserved ejection fraction (HFpEF): the absence of therapies that directly and dynamically address abnormal blood pressure regulation during daily activity and exertion.
The company’s origin traces to clinical observations by Dr. Michael Burnam, who noted that certain patients with HFpEF and dual-chamber pacemakers experienced meaningful improvements in symptoms and functional capacity when pacing was adjusted in ways that influenced blood pressure rather than heart rate alone. These observations led to the development of PressurePace™, BaroPace’s proprietary algorithm for blood pressure–regulated atrial pacing (BRT).
Following early feasibility work and intellectual property development, BaroPace assembled a multidisciplinary team of clinicians, engineers, and regulatory experts to systematically evaluate this new therapeutic concept. Early preclinical and benchtop validation supported advancement into human studies, culminating in a structured clinical development program focused on HFpEF.
BaroPace’s clinical strategy has progressed through a series of prospective human trials conducted in India. RelieveHFpEF-I, the First-in-Human study, demonstrated that dynamically modulating atrial pacing based on blood pressure during exercise improved treadmill performance and patient well-being compared with standard pacemaker therapy. These findings established the physiologic rationale for blood pressure–regulated pacing in HFpEF and were published in ESC Heart Failure.
Building on this foundation, RelieveHFpEF-II was conducted from 2023–2024 as a controlled crossover study in patients with HFpEF and dual-chamber pacemakers. The trial demonstrated consistent improvements in exercise capacity, functional status, symptom burden, 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.
With two successful human trials completed and published, BaroPace is now advancing toward RelieveHFpEF-III, a pivotal, randomized, double-blind clinical trial in India designed to support regulatory approval and commercialization. The planned study will enroll 122 patients with HFpEF and hypertension and compare standard dual-chamber pacing to BaroPace BRT therapy over six months, with first patient enrollment targeted for 2026.
Today, BaroPace stands at the transition from clinical validation to late-stage development, with a differentiated therapy, reproducible human data, and a clear regulatory and commercial pathway focused on a large, underserved HFpEF population.