PressurePace™

A Medical Breakthrough

Supported by Three Published Retrospective Clinical Trials Totaling 230 Patients Followed for up to Six Years…

  • Preliminary Data Reported at the Heart Rhythm Society international meeting, May 2019, San Francisco California.
  • Second Heart Rhythm Society abstract published May 2020.
  • (2020 Heart Rhythm Society international meeting in San Diego was cancelled due to Covid-19)
  • Third Heart Rhythm Society abstract published May 2021 and awarded an oral presentation at the July 2021 international meeting in Boston.

Using Blood Pressure to Regulate Pacemakers

  • Current pacemakers are regulated solely by Rate Modulation, changing heart rate according to patient activity estimated by sensors for motion and respiratory activity.

PressurePace™ – Our Proprietary Technology

PressurePace™ is the proprietary technology of BaroPace™ that, for the first time, acquires real-time blood pressure readings from an external measurement source such as cuff-based or wearable blood pressure measuring device, processes those readings together with standard pacemaker functions in a small or mobile computing device – such as a computer tablet, smartphone app, smart watch or similar device – to determine the patient’s optimal heart rate to treat heart failure with preserved ejection fraction (HFpEF) or resistant hypertension.  PressurePace™ then communicates with a patient’s pacemaker via a cyber-secure closed loop system that reprograms the pacemaker, if needed, in order to achieve the optimal physiologic heart rate by stimulating the right atrium of the heart which corresponds to normal cardiac physiology.  Before PressurePace™ completes a pacemaker reprogramming cycle, another innovation within the PressurePace™ program queries the patient for subjective input (such as, “How are you feeling now?”) which, for the first time, allows the patient to interact with his or her pacemaker control in real-time.

PressurePace™ represents a number of potential “firsts”:

  • The world’s first real-time closed-loop physiologic pacemaker control system.
  • The world’s first real-time closed-loop physiologic control algorithm that remotely controls a pacemaker without the need for human intervention.
  • The world’s first real-time closed-loop physiologic pacemaker control system that includes real-time patient interaction.
  • The world’s first potential therapy for HFpEF and drug resistant hypertension based upon the restoration of normal physiology without the need for drugs, the induction of non-physiologic heart function, complex surgical procedures, or destruction of normal tissue.

How does it work?

The functionality of PressurePace™ v2, a real-time closed loop system for physiologic pacemaker control, is being evaluated in an Early Feasibility, First-in-Human clinical trial that began in the fall of 2023 in four major medical centers in India. This double blind, cross-over design trial evaluates the safety and efficacy of PressurePace™ v2 in 16 patients with HFpEF over a seven-week period using each subject as his/her control. PressurePace™ v2 utilizes a hospital grade blue-tooth enabled blood pressure cuff and twice a day BaroPacing during the 3-week BaroPacing arm of the trial.  When safety and efficacy endpoints are achieved, expected by third quarter 2023, an FDA IDE for a Phase II pivotal trial in HFpEF (US-based, 150 subjects, multi-center 6 months, double blind with each subject as their own control,) will be applied for. This trial will utilize  PressurePace v2, and additionally evaluate in a smaller patient cohort PressurePace v3.

PressurePace v3 will substitute a medical grade wearable cuffless blood pressure measurement device for the conventional blood pressure cuff. This device is a co-development between BaroPace Inc and Centrus Diagnostics, Inc.  The Company’s CentrusDx smart bracelet is capable of acquiring medical-grade blood pressure readings every 5-10 seconds regardless of wrist position or motion, for all skin tones and adults of all ages. A full-function prototype, CDX1, will begin clinical validation in February 2024, and is expected to begin FDA 510(k) testing in April 2024.  A functional interface between PressurePace v3, CDX1, and a dual chamber pacemaker with wireless communication has already been achieved.

Our Business Proposition
Relies upon the Transitive Property

Pacemaker companies are in a constant game of leapfrog to develop small, sometimes trivial improvements to their devices to maintain their average system pricing.

Pacemaker companies need to continue to evolve to survive in the current healthcare economic environment.

A pacemaker improvement that not only paces, but also treats additional disease states, such as Drug Resistant Hypertension and Heart Failure with Preserved Ejection Fraction, would render current devices outdated, even obsolete. Since up to seventy percent of patients with pacemakers also have hypertension, a pacemaker that “BaroPaces” will be a must-have for pacemaker manufacturers. Additionally, Third-party payers favor therapies that reduce overall burden to the healthcare system.