NEW YORK (February 23, 2017)—E-QURE Corp. a leader in medical devices for the treatment of advanced wound care, announced today that it has received approval from the U.S. Food and Drug Administration (FDA) to conduct its pivotal trial for the company's patented Bio-electrical Signal Therapy Device (BST Device) in the treatment of chronic wound care as a staged study, potentially shortening the duration of the trial.
The conditional approval that was granted to E-QURE under an Investigational Device Exemption (IDE), in October 2016 stated the company may conduct the safety stage of the trial in one U.S. institution. The company has since requested an increase in the number of institutions in the safety stage and the FDA responded with an approval, increasing the number of U.S. institutions where the first 10 patients will be treated from 1 to 5.
“We are delighted that the FDA has granted us the opportunity to shorten the trial period by increasing the number of sites we can use. This may shorten our whole study period by more than six months. We intend to fulfill all FDA requirements and start the trial as soon as we can,” sated Ron Weissberg, Chairman of E-QURE Corp.
The approval to increase the number of institutions where the first 10 patients can be treated is expected to allow the Company to dramatically shorten the safety portion of the trial, resulting in an accelerated timeline to treat all 90 patients planned for inclusion in the study. E-QURE may request approval to expand enrollment in the study to 90 patients following its submission of an IDE supplement, which includes a safety profile of the 10 patients who completed 56 days’ treatment with the E-QURE BST device.
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