NEW HOPE, Pa., Oct. 26, 2016 /PRNewswire/ -- BackBeat Medical Inc. today announced that clinical data for the company'spatented Programmable Hypertension Control (PHC) therapy for the treatment of hypertension will be presented at Transcatheter Cardiovascular Therapeutics (TCT) 2016, Oct. 29-Nov. 2, in Washington.
The scientific session will feature results from the first-in-man study of BackBeat's PHC algorithm incorporated into a dual chamber pacemaker. Karl-Heinz Kuck, M.D., the head of the Department of Cardiology at Asklepios Klinik St. Georg in Hamburg, Germany, will deliver the oral presentation "Pacing-based Treatments of Hypertension: BackBeat Medical" during the session "Novel Hypertension Approaches Beyond Renal Denervation" at 4:56 p.m. EDT on Sunday, Oct. 30 in Room 209, Level 2 at the Walter E. Washington Convention Center.
On Monday, Oct. 31, Darren Sherman, co-founder of BackBeat Medical, will participate in the Shark Tank Innovation Competition beginning at 8 a.m. in Room 202, Level 2. His presentation, "Pacemaker-Based Treatment for Hypertension (Backbeat)" will begin at 10:20 a.m. EDT. The Shark Tank Innovation Competition invites participants to present novel technologies relevant to the monitoring, diagnosis and treatment of coronary, endovascular, or structural heart disease.
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.
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