LOD, Israel, Oct. 7, 2008 (GLOBE NEWSWIRE) -- InterCure Ltd., a medical device company publicly traded on the Tel-Aviv Stock Exchange (TASE:INCR), today announced that Circulation: Heart Failure, a peer reviewed medical journal of the American Heart Association, published the results of a randomized, controlled pilot study which found that device-guided breathing with RESPeRATE significantly improved the clinical parameters and symptoms in moderate heart failure patients.
Congestive heart failure affects about 5 million patients in the U.S. alone. It is the most widespread cause of hospitalization of patients over 65, with over 1 million hospitalizations every year. The total cost of treating the disease is estimated at $33 billion annually. About 91% of congestive heart failure sufferers have a medical history involving hypertension.
The study was conducted by Gianfranco Parati, MD, Professor of Medicine, Department of Clinical Medicine and Prevention, University of Milano-Bicocca; Head, Department of Cardiology, S.Luca Hospital, IRCCS Istituto Auxologico Italiano, Milano, Italy. It found that within 10 weeks of twice daily 15 minute at-home treatment sessions with RESPeRATE, patients demonstrated a significant reduction in the New York Heart Association (NYHA) classification, which measures the severity of chronic heart failure symptoms. The decrease in severity was frequently attributed to the reduction in dyspnea (shortness of breath), allowing for a broader range of physical activity, as documented by the 16% increase in peak oxygen consumption during cardiopulmonary stress testing under controlled conditions on a cycloergometer. This finding was consistent with a 24% improvement in the Minnesota Quality of Life Questionnaire (MQOL) score, which is used to assess heart failure patients' quality of life. Objective physiological parameters also were improved, with an average 22% improvement in both Left Ventricular Ejection Fraction (LVEF) and Pulmonary Artery Blood Pressure (PAP).
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After
Measure Baseline 10 wks Change P-Value*
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NYHA 2.84 1.78 37% less than 0.05
MQOL 41.4 31.0 24% less than 0.05
LV Ejection Fraction (%) 32 39 22% less than 0.05
Pulmonary AP (mmHg) 49 38 22% less than 0.05
Peak VO2 during CPT**
(ml/kg/min) 12.2 14.1 16% less than 0.05
Maximal Workload
during CPT** (Watt) 74 85 15% less than 0.05
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* All results were significant when either compared with baseline
value or with a control group that continued with usual care.
** CPT = cardiopulmonary stress test on a treadmill
"Regular slow breathing has long been known to improve autonomic cardiac regulation and reduce excess chemoreflex sensitivity in heart failure, but the clinical relevance of respiratory training is still widely debated largely due to the required prolonged training period and inconsistent compliance of patients with routine exercise at home," said Parati. "RESPeRATE provides a practical, easy-to-use solution with significant results. More study is required, but this is a promising step in evaluating the benefits of paced breathing in this patient population. Based on previous publications and our findings with slow breathing training, it is possible that this treatment has a positive effect on the autonomic nervous system which plays a prominent role in the disease continuum from pre-hypertension through hypertension to heart failure."
"The results of this key study expand the growing body of scientific evidence that already has proven RESPeRATE as a clinically valid treatment for hypertension," said Erez Gavish, President and CEO of InterCure. "We plan to continue exploring the potential of RESPeRATE and our patented device-guided breathing technology to benefit patients with other cardiovascular diseases in the future."
RESPeRATE is the only FDA-cleared, CE-marked device indicated for the adjunctive treatment of hypertension. RESPeRATE's clinical efficacy in lowering blood pressure has been validated in 10 separate published studies and over 100,000 units have been sold to consumers. RESPeRATE has not been cleared for use in the treatment of heart failure in the United States, European Union or elsewhere.
About InterCure Ltd. and RESPeRATE
InterCure Ltd. (TASE:INCR) is disrupting the $42 billion hypertension industry with the world's first FDA-cleared, OTC blood pressure treatment device, RESPeRATE(r) (www.resperate.com). In a market where seven out of 10 hypertensives are NOT controlled despite the availability of more than 100 blood pressure medications, RESPeRATE provides an effective non-drug adjunctive therapy with no side effects.
RESPeRATE has gained widespread support of hypertension specialists and has secured regulatory clearance in most key international markets. Ten separate clinical studies have proven the device's efficacy and safety, and RESPeRATE is now featured in more than 20 popular and professional text books.
With more than 100,000 units sold, thousands of supportive clinicians worldwide and one of the world's most popular hypertension websites, InterCure is now introducing RESPeRATE into retail pharmacies to increase access to hypertension sufferers.
InterCure has an exciting product pipeline based on its broadly-patented "Device-Guided Breathing" technology platform. This technology enables a systematic reduction in sympathetic outflow of the autonomic nervous system, one of the key underlying causes of a number of medical conditions.