BackBeat Medical Clinical Data Presented at TCT 2016 Show Continued Reduction in Blood Pressure Over One Year with Cardiac Pacing-Based Hypertension Treatment
NEW HOPE, Pa., Oct. 31, 2016 /PRNewswire/ -- BackBeat Medical Inc. today announced the presentation of data demonstrating a continued significant reduction in blood pressure over a one year period with the company's patented Programmable Hypertension Control (PHC) therapy for the treatment of hypertension. The data were presented by the study's principle investigator, Karl-Heinz Kuck, M.D., at the Transcatheter Cardiovascular Therapeutics (TCT) 2016 conference in Washington, DC.
The study enrolled 35 hypertensive patients who received a pacemaker developed by BackBeat, called the Moderato™, that incorporates the company's proprietary PHC algorithm. After a one month run-in period without activation of the PHC therapy, 27 patients met the study inclusion criteria and had the PHC therapy activated. Previously reported data from the study demonstrated a decrease in office cuff pressure of 16 mmHg from pre-activation levels after three months of therapy. Of the 27 patients included in the study, 25 patients consented to continue the follow-up up to two years, and all 25 patients have completed one year of follow-up. The systolic blood pressure remained low at one year with an average reduction of 13.9 mmHG (p<0.001). No significant difference was observed between the change at three months and one year (p=0.4). In the 13 patients who have reached 18 months and the ten patients who have reached 24 months of therapy, the effect is maintained with respective average reductions of 18.7 and 19.7 mmHg (p<0.001).
"PHC therapy quickly reduces systolic blood pressure and has demonstrated a sustained response out to two years," said Dr. Kuck, the head of the Department of Cardiology at Asklepios Klinik St. Georg in Hamburg, Germany. "Incorporating hypertension control into a standard pacemaker is a unique approach which can provide a sustained benefit for patients without the side effects and compliance challenges associated with hypertension medications."
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. This technology can be readily incorporated into marketed pacemakers using standard leads and standard lead placement. It also could be added to already implanted pacemakers as a software download performed in the clinic.
Yuval Mika, Ph.D., CEO and co-founder of BackBeat Medical, added, "Hypertension is uncontrolled in approximately 38% of the total pacemaker population. These patients could benefit substantially from a potent hypertension therapy such as PHC that could be included in their already necessary pacemaker. We are currently working to obtain regulatory approval in Europe for PHC therapy and are enrolling patients in a 170-patient, randomized, double-blind study designed to further investigate the benefit of PHC therapy in hypertensive pacemaker patients."
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 20 mmHg 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. 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. While pacemaker prices have generally been in decline with the exception of new MRI-compatible devices, the introduction of new features, like MRI-compatible pacemakers, resulted in significant increases in device selling price. Furthermore, the introduction of new therapeutic capabilities in pacemakers, like biventricular pacing for the treatment of heart failure, resulted in a significant increase in device price. The addition of features and additional therapeutic capabilities can also affect market share by providing competitive advantages and product differentiation to first movers. 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.
About BackBeat Medical
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 up to two years.
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SOURCE BackBeat Medical Inc.