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?

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Second Publication

Heart Rhythm Society (“HRS”) 2020

Permanent Pacing And Decline In Blood Pressure In Patients With Drug Resistant Hypertension: A Large Retrospective Study.

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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.

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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.

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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.

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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

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Milestones

All Phase 1 Clinical Trial Endpoints Met

June 18, 2024

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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.

www.businesswire.com

BaroPace Receives Approval for First-in-Human Clinical Trial

July, 25, 2023

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Out of 121 startups advancing pacemakers, BaroPace is considered within the top 5

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Press Release:

Michael Coyle

May 9, 2022

BaroPace issued a Press Release announcing Michael Coyle has joined the Company’s Board.

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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.

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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