Lod, Israel.— September 27th, 2011 — InterCure Ltd., a medical device company publicly traded on the Tel-Aviv Stock Exchange (TASE: INCR), today announced that European Journal of Heart Failure, a peer reviewed medical journal of the European Society of Cardiology, published the results of a 72-patients, randomized, controlled study which demonstrated that device–guided respiratory modulation with RESPeRATE applied at the home setting can significantly relieve symptoms of heart failure in elderly patients.
Chronic heart failure (CHF) 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 CHF sufferers have a medical history involving hypertension.
The study was conducted by Inger Ekman, MD, Professor of Medicine, Institute of Health and Care Sciences, the Sahlgrenska Academy, University of Gothenburg, Sweden with funding from the Swedish Heart Lung Foundation. It was found that after 4 weeks of twice daily 20 minute at-home treatment sessions with RESPeRATE, patients, who modified the breathing as directed by the device , demonstrated a reduction in the severity of CHF measured by New York Heart Association (NYHA) classification, and in dyspnea (shortness of breath) that is the major reason for seeking care in the CHF population. The observed reduction was significant by both its absolute mean and in comparison with control group and/or with patients, who didn't modify breathing as directed by the device.
"CHF is disabling and leads to decreased quality of life, frequent hospitalizations and poor survival. The patient's subjective response to the condition is associated with symptoms that reflect physical aspects as well as integrated aspects of lifestyle, anxiety, depression, and expectations of the patient. The device-guided respiratory modulation provided by the RESPeRATE might have the potential to relieve symptoms of heart failure in outpatients by changing their Device-guided respiratory modulation have the potential to relieve symptoms of heart failure in outpatients by changing their breathing pattern" said Prof. Ekman.
Results are consistent with those published last year in Circulation Heart Failure by Gianfranco Parati, Professor of Medicine from St. Luca Hospital, in Milano and his colleagues. That randomized –controlled study with similar use of RESPeRATE at home over 8 weeks is feasible in patients with heart failure and systolic dysfunction and demonstrated significant improvement in clinically relevant parameters for, including CHF severity; left ventricular ejection fraction and pulmonary pressure and function.
"The positive effect of the RESPeRATE on CHF patients reported by these independent studies 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 respiratory modulation technology to benefit patients with other cardiovascular diseases."
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 200,000 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. (Tel-Aviv Stock Exchange: INCR) is disrupting the $42 billion hypertension industry with the world's first FDA-cleared, OTC blood pressure treatment device, RESPeRATE® (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 200,000 units sold, thousands of supportive clinicians worldwide and one of the world's most popular hypertension websites, InterCure is allowing now introducing RESPeRATE into retail pharmacies to increase access to hypertension sufferers.
InterCure has an exciting product pipeline based on its broadly-patented "Respiratory Modulation" 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.
Forward-Looking Statements
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Journal
European Journal of Heart Failure