Hypertension (high blood pressure) is the #1 attributable risk for death worldwide according to the World Health Organization.
of Pacemaker Patients
~700K a Year have
~972M of the World
Adult Population has
BackBeat’s Programmable Hypertension Control (PHC) therapy is comprised of proprietary pacing algorithms that are incorporated into standard pacemakers using standard leads and standard lead placement and thus has broad applicability. PHC offers a new potent device-based therapeutic alternative, potentially opening up a large market to treat patients with hypertension, particularly HTN patients that already have or require a pacemaker. BackBeat’s PHC algorithm reduces ventricular filing to lower blood pressure while modulating the response of the baroreflex to prevent activation of the autonomic nervous system. The effect on the autonomic nervous system is the key component in maintaining chronic low blood pressure with minimal impact on cardiac function. Clinical results generated to date using BackBeat’s own Moderato™ pacemaker incorporating BackBeat’s PHC algorithms demonstrate that this therapy has a substantial and sustained therapeutic effect on blood pressure as determined by both in-office cuff measurements (average reduction of 24 mmHg from baseline) and 24-hour ambulatory measurements (average reduction of 14 mmHg from Baseline) with clinical follow up extending past two years in certain patients.
BackBeat Medical Inc. is a medical technology company founded in 2010 to develop novel cardiac stimulation-based therapies for hypertension and heart failure. BackBeat has developed a patented cardiac pacing-based treatment for hypertension (HTN) called programmable hypertension control (PHC) therapy. PHC is comprised of proprietary pacing algorithms that can be readily incorporated into standard pacemakers using standard leads and standard lead placement and thus has broad applicability. PHC offers a new potent device-based HTN therapeutic alternative potentially opening up a large market to treat HTN patients, particularly HTN patients who already have or require a pacemaker. Clinical results generated to date using BackBeat’s own Moderato™ pacemaker incorporating PHC algorithms demonstrate that this therapy has a substantial and sustained therapeutic effect on blood pressure as determined by both in-office cuff measurements (average reduction of 24 mmHg from baseline) and 24-hour ambulatory measurements (average reduction of 14 mmHg from Baseline) with clinical follow up extending past two years in certain patients. BackBeat's PHC therapy is protected by an extensive global patent portfolio.
Hypertension (HTN), or high blood pressure, affects an estimated 75 million American adults (1 in 3) according to the CDC and over 1 billion adults globally according to the WHO. HTN is one of the most important factors contributing to cardiovascular morbidity and mortality, accounting for over 9.4 million global deaths annually. Unacceptably high blood pressure is defined as systolic pressure >140 mmHg in the absence of other cardiovascular risk factors, or >130 mmHg in the presence of other risk factors. Cardiovascular risk doubles for every 10 mmHg increase in systolic blood pressure, and mortality rate is doubled with an increase of 20mmHg in systolic blood pressure. Hypertension increases dramatically with age from 7.3% for ages 18-39 to 65% for ages 60+. The estimated direct and indirect yearly cost of hypertension in the U.S. is $46.6 billion. Medications are frequently effective in controlling blood pressure but require daily strict compliance by patients and can cause side effects that make them difficult for patients to tolerate. Only 54% of U.S. HTN patients have their high blood pressure under control (CDC). Further, data from the NIH’s landmark Systolic Blood Pressure Intervention Trial (SPRINT) published in 2015 show that more aggressive treatment to achieve a target systolic pressure of 120 millimeters of mercury (mm Hg), reduced rates of cardiovascular events, such as heart attack and heart failure, as well as stroke, by almost a third and the risk of death by almost a quarter, as compared to the target systolic pressure of 140 mm Hg.
Pacemakers are permanent implants that directly stimulate, or “pace,” the heart to beat at a normal rate. Indications for permanent pacing include the following: symptomatic sick sinus syndrome, including symptomatic sinus bradycardia, tachycardia-bradycardia syndrome, atrial fibrillation with sinus node dysfunction, chronotropic incompetence (inability to increase the heart rate to match a level of exercise) and various degrees of conductance block between the atrium and the ventricle. The annual value of the global pacemaker market is approximately $4.2B with more than 1 million pacemaker procedures performed worldwide every year. In recent years new therapeutic capabilities were integrated into pacemakers, like biventricular pacing for the treatment of heart failure. The use of well established pacemaker technology for treatment of other diseases; especially in a population of patients requiring a pacemaker, provide significant benefit to these patients at a relatively low risk and allow a safe way to explore the benefits of expanding the use of the therapy to patients that do not require an implant of a pacemaker.
Hypertension in the population of people indicated for an implant of a pacemaker
It is estimated that more than 70% of the patients that are indicated for the implant of a pacemaker have hypertension. The main reason may be attributed to the average age of the pacemaker patient population being 73 years old and the dramatic increase in the prevalence of hypertension in people over 60 years old. Hypertension is uncontrolled in approximately 55% of these people (approximately 38% of the total pacemaker population). These patients could benefit substantially from a hypertension therapy like PHC that could be included in their already necessary pacemaker.
August 28, 2016
Clinical Trial Results of the BackBeat Medical Programmable Hypertension Control (PHC) Therapy for the treatment of Hypertension. Presented in the Clinical Trial Update session of the ESC Congress in Rome 2016.
BackBeat Medical PHC therapy and the Moderato™ are exclusively for clinical investigations for the treatment of hypertension and are not available commercially.