BaroPace™
Timeline
2014 - 2018
Initial observations by
Michael Burnam MD lead to his theory that BP can be regulated by pacing the heart.
February 2019
BaroPace LLC is incorporated in the State of Delaware.
Changed to C Corp, BaroPace, Inc. in December 2020
February 2019
First retrospective
clinical trial
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.
March 2019
Second retrospective
clinical trial
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.
May 2019
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? More…
May 2019
Patent filings
Filings of first two patents.
Three more have been filed since for a total of five patents, including application for international protection.
January 2020
Scientific Advisory Board is formed.
World-renowned cardiac electrophysiologist, Dr. Kenneth Ellenbogen FACC FHRS, becomes Chairman of the Scientific Advisory Board.
January 2020
Third retrospective clinical trial
Sapienza Medical School, Rome, reviews data on 176 patients with DRH, HFpEF, and implanted pacemakers followed for up to six years.
May 2020
Second publication
HRS 2020, Permanent Pacing And Decline In Blood Pressure In Patients With Drug Resistant Hypertension: A Large Retrospective Study More…
June 18, 2020
Phase I Engineering begins.
PressurePace™ bench-top engineering phase formally commences with Medtronic.
June 20, 2020
Pre-clinical and regulatory planning for prospective clinical trials (Phase III)
August 2020
Scientific Advisory Board: New Member
Uri Elkayam, MD, a nationally and internationally known expert in heart failure, joins the Scientific Advisory Board.
October 2, 2020
Phase IIIA: Human Studies
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.
January 2021
PressurePace™ Engineering Prototype is completed.
January 2021
176 patients with DRH, HFpEF, and dual chamber pacemakers showed a significant drop in blood pressure and improvement in HFpEF.
February 2021
First BaroPace™ Chairside Study is completed.
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. More…
May 2021
Two multi-center prospective clinical trials receive IRB Approval: Chairside I, v3 and Treadmill I.
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.
Summer 2021
Further development of PressurePace™
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.
July 2021
Third publication
HRS 2021, Permanent Atrial Pacing In Patients With Heart Failure And Preserved Lv Ejection Fraction: A Retrospective Analysis Of Clinical Outcomes. More…
September 2021
PressurePace™ Autonomous Bedside Module development begins.
The Module wirelessly receives blood pressure data, calculates the optimal pacing command to optimally regulate the subject’s blood pressure, and wirelessly transmits the command to the subject’s pacemaker for execution. The Module contains numerous real-time physiologic safeguards and cybersecurity features. Real-time data is uploaded to a secure server.
September 2021
Scientific Advisory Board:
Three New Members
Mark Kroll PhD, Elisabeth Neely BA, BS, and Dominic Sica MD join the Company’s Scientific Advisory Board.
November 17, 2021
Completed: Acute Animal Model of Hypertension
PressurePace™ v2 with safety and security subroutines is successfully tested in an acute animal model of hypertension.
November 2021
AI Modeling
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.
December 2021
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. More…
April 2022
First In Human Pilot Feasibility Study of PressurePace™ AI in patients with HFpEF caused by hypertension receiving a pacemaker for standard indications
In collaboration with a medical device company, the FIH Pilot Study will evaluate the safety and efficacy of PressurePace™ AI for the improvement of exercise tolerance and blood pressure control in patients with HFpEF, DRH, and dual chamber pacemakers.
Phase I
Benchtop Engineering
Phase II
Animal Testing
Phase III
Human Testing
Summary of BaroPace™ Research & Development Plan
Based upon the observation that blood pressure can be regulated by pacing the Right Atrium using a standard cardiac dual chamber pacemaker, a closed-loop system has been designed that consists of three parts: a blood pressure measuring device, an application containing an algorithm, and a dual chamber cardiac pacemaker.
In the standard iteration, the blood pressure measuring device, such as a wearable blood pressure watch, measures the wearer’s blood pressure and sends the reading with security encryption via Bluetooth technology to the application which has been paired to receive it. The application, which might be resident in a smart phone or watch, receives the signal, decrypts and authenticates it, and the patent-pending algorithm (PressurePace™) calculates the optimal Right Atrial pacing rate. The command to alter the pacemaker’s Right Atrial Pacing Rate (higher, lower, or no change) is encrypted and sent via Bluetooth communication to the pacemaker that has been paired to the application. The command is decrypted by the pacemaker, authenticated, and the pacemaker is reprogrammed to follow the command. The process than repeats as often as necessary, such as every minute or longer intervals, or as programmed by the supervising physician.