New York, NY–March 9, 2009–InterCure Ltd., a medical device company publicly traded on the Tel-Aviv Stock Exchange (TASE: INCR), today announced a new study published in the peer-reviewed Journal of Human Hypertension. The advance online publication of the study is now available on the journal’s website. The study will also be published in the May issue of the journal, Volume 23, Issue 5. It demonstrates use of RESPeRATE–the only medical device cleared by the FDA and CE-approved for the adjunctive treatment of hypertension–for 15 minutes a day significantly lowered blood pressure in non-insulin dependent diabetics. This study reinforces nine previous studies that validate the efficacy of the device.
The randomized, controlled trial of 66 non-insulin dependent (Type II) diabetic patients with uncontrolled blood pressure was conducted by Moshe H. Schein, MBChB, M.S., Hadassah-Hebrew University Medical Center.
Despite the fact that 82 percent of the study population was already taking antihypertensive medication before the start of the trial, baseline systolic blood pressure levels remained high while diastolic levels were controlled. Study participants using device-guided breathing with RESPeRATE at home for eight weeks experienced a significant reduction in office systolic blood pressure (mean+SE) -10.0+1.8 mm Hg (p< 0.0001), but similar results were not seen in the control group +1.6+2.1 mm Hg (p>0.4). A full 88 percent of patients using RESPeRATE experienced a significant blood pressure reduction, in contrast to only 45 percent of the control group.
“A high percentage of diabetic complications can be attributed to hypertension. However data shows that only 20 percent of diabetic patients reach the recommended target blood pressure,” said Dr. Schein, the lead investigator. “It is therefore encouraging that an effective non-drug therapy can help this population improve its blood pressure control. The compliance with treatment in the study was high and in addition the patients reported feeling more relaxed after the device-guided breathing.”
Hypertension is a common co-morbidity in patients with diabetes mellitus and is an important factor in the increased risk of coronary heart disease and stroke in diabetics. Lowering blood pressure in the diabetic population is crucially important, yet difficult to achieve. The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure recommends aggressive hypertension treatment for diabetics, including pharmacological and non-pharmacological interventions, in order to reduce blood pressure below 130/80 mm Hg. Despite this aggressive approach, only 44.3 percent achieve blood pressure goals below 140/90 mm Hg and only 20.4 percent reach the recommended target of below 130/80 mm Hg.
“This new study provides a clear demonstration of the non-drug benefits of RESPeRATE among the high-risk diabetes population,” said Erez Gavish, president and CEO of InterCure. “Diabetics facing a daily regimen of monitoring, insulin injections and prescription medication for secondary conditions have long supported the truly natural hypertension treatment RESPeRATE provides. Diabetic nurse educators and clinicians across the country now have even more reason to discuss RESPeRATE as a viable option among this hard-to-control, high-risk patient population.”
