News
Publications
First Publication
Heart Rhythm Society (“HRS”) 2019
Permanent Pacing is Associated with Significant Decline in Blood Pressure among Elderly Patients with Drug Resistant Hypertension: A New Paradigm in Pacing?
Second Publication
Heart Rhythm Society (“HRS”) 2020
Permanent Pacing And Decline In Blood Pressure In Patients With Drug Resistant Hypertension: A Large Retrospective Study.
Third Publication
Heart Rhythm Society (“HRS”) 2021
Permanent Atrial Pacing In Patients With Heart Failure And Preserved Lv Ejection Fraction: A Retrospective Analysis Of Clinical Outcomes.
Fourth Publication
American College of Cardiology (“ACC”) 2022
Beta Blocker Therapy Blunts the Blood Pressure Lowering Effect of Atrial Pacing in Hypertensive Patients: A Possible Confirmation of the Sympatholytic Effect of Pacing.
Fifth Publication
Heart Rhythm Society (HRS), 2024
Real-time Closed-Loop Regulation of Permanent Pacing Rate using External Home Blood Pressure Measurements in Patients with HFpEF and Hypertension: A First-in-Man Report.
Sixth Publication
Peer-Reviewed Manuscript in Press
Permanent Pacing Reduces Blood Pressure in Older Patients with Drug Resistant Hypertension: A New Pacing Paradigm?
Nguyen, Bich Lien, et al.
Innovations in CRM: Original Clinical
Seventh Publication
Peer-Reviewed Manuscript in Press
Safety and efficacy of adaptive atrial pacing regulated by blood pressure during low-level exercise; A proof-of-concept study,
Burnam, Michael H., et al.
ESC Heart Failure
Milestones
Scientific Advisory Board: New Member
January, 2024
Sanjiv J. Shah, MD, an internationally recognized expert in heart failure with preserved ejection fraction (HFpEF), joins the Scientific Advisory Board.
BaroPace, Inc. Announced First Patient Enrolled in Non-Pharmacologic Hypertension and Heart Failure Treatment Trial
August 22, 2023
BaroPace Inc announces first enrollment in its First-in-Human multi-center clinical trial in India, RelieveHFpEF-II.
Out of 121 startups advancing pacemakers, BaroPace is considered within the top 5
Press Release:
Michael Coyle
May 9, 2022
BaroPace issued a Press Release announcing Michael Coyle has joined the Company’s Board.
AI Modeling
November 2021
AI Modeling to complete a fully autonomous PressurePace™ algorithm and closed loop system (Blood Pressure Measuring Device – PressurePace™ – Pacemaker) suitable for both the resting and exercise states including safety protocols, necessary encryption, and a device-specific homeware link for outpatient monitoring.
Completed: Acute Animal Model of Hypertension
November 17, 2021
PressurePace™ v2 with safety and security subroutines is successfully tested in an acute animal model of hypertension.
Scientific Advisory Board:
Three New Members
September 2021
Mark Kroll PhD, Elisabeth Neely BA, BS, and Domenic Sica MD join the Company’s Scientific Advisory Board.
PressurePace™ Autonomous Bedside Module development begins.
September 2021
The Module wirelessly receives blood pressure data, calculatesRead More
Further development of PressurePace™
Summer 2021
PressurePace™ v2 will include more advanced treatment subroutines and the addition of system safeguards in preparation for human study. The design and modeling of PressurePace™ will begin.
Two multi-center prospective clinical trials receive IRB Approval: Chairside I, v3 and Treadmill I.
May 2021
Chairside-I, v3 will study patients with DRH at rest to further develop PressurePace™. Treadmill I will study exercise performance and blood pressure control in patients with HFpEF using a PressurePace™ simulation.
First BaroPace™ Chairside Study is completed.
February 2021
BaroPace™ successfully completed Chairside I, v1 Study. This clinical trial demonstrated the feasibility of significantly reducing both systolic and diastolic blood pressure in patients with hypertension and dual chamber pacemakers using PressurePace™. Trial results will be submitted for peer-reviewed publication.
Sapienza Medical School, Rome, Retrospective Study is completed and submitted for publication.
January 2021
176 patients with DRH, HFpEF, and dual chamber pacemakers showed a significant drop in blood pressure and improvement in HFpEF.
PressurePace™ Engineering Prototype is completed.
January 2021
Phase IIIA: Human Studies
October 2020
BaroPace™ receives approval from the Institutional Review Board (IRB) to proceed with the Company’s first prospective multi-site clinical trial, the Chairside I, v1 Study.
Scientific Advisory Board: New Member
August 2020
Uri Elkayam, MD, a nationally and internationally known expert in heart failure, joins the Scientific Advisory Board.
Pre-clinical and regulatory planning for prospective clinical trials (Phase III)
June 20, 2020
Phase I Engineering begins.
June 18, 2020
PressurePace™ bench-top engineering phase formally commences with Medtronic.
Third retrospective clinical trial
January 2020
Sapienza Medical School, Rome, reviews data on 176 patients with DRH, HFpEF, and implanted pacemakers followed for up to six years.
Scientific Advisory Board is formed.
January 2020
World-renowned cardiac electrophysiologist, Dr. Kenneth Ellenbogen FACC FHRS, becomes Chairman of the Scientific Advisory Board.
Patent filings
May 2019
Filings of first two patents.
Three more have been filed since for a total of five patents, including application for international protection.
Second retrospective
clinical trial
March 2019
At the Cardiovascular Medical Group of Southern California in Los Angeles, Eli Gang MD studies 32 patients with DRH and HFpEF, one year pre- and one year post-pacemaker implant.
First retrospective
clinical trial
February 2019
Michael Burnam MD conducts geriatric group study in Los Angeles,
30 patients with DRH and HFpEF, one year pre- and one year post-pacemaker implant.
BaroPace LLC is incorporated in the State of Delaware.
February 2019
Changed to C Corp, BaroPace, Inc. in December 2020
Initial observations by Michael Burnam MD lead to his theory that BP can be regulated by pacing the heart.
2014 – 2018
Engineering Prototype
PressurePace v1
Completed
Animal Model Testing
PressurePace v2
Completed
Pilot Simulation
RelieveHFpEF-I
Completed
Phase I Trial, India
RelieveHFpEF-II
Completed
Phase II Trial, India
RelieveHFpEF-III
Planning Phase