About BaroPace™

 

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Early 1800s

The important relationship between heart rate and blood pressure was identified by Jean Léonard Marie Poiseuille in the 19th century.

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1932

The cardiac pacemaker was invented.

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Today's Pacemakers
Modern pacemakers don’t regulate heart rate in response to blood pressure.
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2019 | BaroPace™ is Established
BaroPace™ technology is the key to the next generation of cardiac pacing. Using BaroPace’s revolutionary patent-pending algorithm PressurePace™, all dual chamber pacemakers and dual chamber cardio-defibrillators can be regulated in real-time in response to blood pressure and other physiologic and physiochemical parameters.

Why is this important?

The discovery of a new pacemaker control paradigm 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 Drug Resistant Hypertension and the most common form of Heart Failure, HFpEF.

What is Drug Resistant Hypertension (DRH)?

  • More than 40% of patients with High Blood Pressure are resistant to treatment (Drug Resistant Hypertension, DRH) an estimated 3.5 million adults in the U.S. and 870 million worldwide, at an annual cost of $17.9 billion in the U.S. beyond the cost associated with nonresistant hypertension. Besides an increased incidence of heart attack, stroke, and death, DRH often results in Heart Failure due to excessive thickening of heart muscle (so-called Diastolic Heart Failure now known as HFpEF).
  • Dramatically increases the risk of heart attack, stroke, kidney failure, and death.
  • Accounts for one half-trillion dollars of annual worldwide healthcare cost.
  • No drug or device therapies have been shown to be safe and effective.

What is HFpEF, also known as Heart Failure with Preserved Ejection Fraction?

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.

Company Story

As Director of Cardiology at a large California Geriatric Cardiology Clinic, Dr. Michael Burnam observed that patients with DRH, and DRH with HFpEF who also received a dual chamber pacemaker showed marked improvement in both DRH, and DRH with HFpEF including fewer hospitalizations for Heart Failure. Dr. Eli Gang confirmed those findings with a second clinical trial, and the combined results were presented at Heart Rhythm Society’s national meeting in 2019. A successful patentability analysis was completed soon after and patent applications were filed, now totaling fourteen, both national and international.

BaroPace™ was formed and additional world-class clinicians and scientists joined as scientific advisors, including Kenneth Ellengbogen, MD, author of the definitive book on cardiac pacemakers, and Uri El Kayam MD, an international expert in Heart Failure, Domenic Sica MD, Director of the Hypertension Clinic at VCU, Mark Kroll PhD, former Chief Technology Officer for St. Jude Medical, and Beth Neely, former Director of Global Regulatory Affairs for St. Jude Medical. The clinical data was presented May 2019 at a prestigious international meeting (Heart Rhythm Society) and published. BaroPace entered into an agreement with Medtronic in 2019 to collaborate on the benchtop development of the PressurePace™ prototype. This was successfully completed and tested in an anesthetized animal model in 2021.

Pilot prospective human testing of the PressurePace™ system in DRH was successfully completed in 2021 (Chairside-I) and the results reported at the American College of Cardiology National Convention in April 2022. Randomized prospective human testing using PressurePace™ comparing exercise tolerance in HFpEF patients compared to standard pacemaker rate modulation was completed in August 2022. Ten out of ten HFpEF patients showed significant improvement in treadmill exercise tolerance with BaroPacing. The results will be submitted for publication.

World-Class Leadership Team

Meet Our Team