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 a wearable blood pressure measuring device, processes those readings together with standard pacemaker functions in a smartphone app or similar device, such as a computer tablet, to determine the patient’s optimal heart rate to lower blood pressure to the desired level, and transmits that encrypted command to the patient’s pacemaker to produce a true physiological heart rate response at rest and during exertion. 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?”), for the first time allowing 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 drug resistant hypertension and HFpEF 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 following video animation portrays the functionality of PressurePace™ v1, a real-time closed loop system for physiologic pacemaker control that will be used in an Early Feasibility, first-in-human clinical trial in the fall of 2022. This trial will evaluate the safety and efficacy of PressurePace™ v1 in patients with Drug Resistant Hypertension over a 28-day period. PressurePace™ v2 will utilize a best-in-class hospital grade blood pressure smartwatch with the capability for more frequent BaroPacing without the need for a blood pressure cuff. This second version of PressurePace™ will be evaluated for safety and efficacy in a 90-day Early Feasibility first-in-human clinical trial in HFpEF caused by hypertension, expected to begin enrollment in the Fall of 2023.
  • A wearable blood pressure measurement device wirelessly transmits real-time blood pressure measurements to a BaroPace™ app in a smartphone or smart watch. The app contains patent-pending PressurePace™ technology that determines the patient’s optimal heart rate based on blood pressure and other pacemaker parameters, and wirelessly transmits that instruction to the patient’s pacemaker. The process is repeated twice daily to treat resting hypertension, and as often as every two minutes using a continuous blood pressure measuring device in patients with HFpEF. A cyber-secure connection to the BaroCloud™ facilitates real-time remote medical supervision, including the capability for telemedicine.
  • Advanced patent-pending PressurePace™ technology include an Artificial Intelligence component that integrates several physiologic variables in addition to Blood Pressure to better regulate pacemaker function for each individual patient’s needs. Examples of other variables include the type and severity of patient activity, ambient temperature, altitude, medications, and even the time of day.

 

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.