NEW YORK, February 23, 2017 /PRNewswire/ --
Could potentially shorten study period by more than six months
E-QURE Corp. (OTCQB: EQUR), 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 one to five.
"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.
E-QURE Corp (OTCQB: EQUR) is a leader in medical devices for the treatment of advanced wound care. E-QURE's breakthrough patented Bioelectrical Signal Therapy (BST) Device is the only method in the world to non-invasively close and heal chronic wounds and ulcers. Current methods of chronic wound treatment at best treat or reduce the wound, but none consistently heal or cure it. The BST Device not only cures wounds, it does so faster, at lower cost, and with more convenience to the patient and the healthcare system. The BST Device has received regulatory approval in Europe and Israel, and is expected to launch in Q1 - Q3 2017 in Israel and Argentina, where approval is pending. E-QURE plans to begin its pivotal U.S. FDA trial in the first quarter of 2017. The Company's pipeline includes additional proprietary wound care products in development.
Safe Harbor Statement
This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995 and federal securities laws. For example, we are using forward-looking statements, when we discuss the potential of E-QURE BST device to treat wounds. These forward-looking statements and their implications are based on the current expectations of the management of E-QURE only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; we may encounter delays or obstacles in launching and/or successfully completing our clinical trials; our products may not be approved by regulatory agencies; we may be unable to retain or attract key employees whose knowledge is essential to the development of our products; results of preclinical studies may not correlate with the results of human clinical trials; our patents may not be sufficient; our products may harm recipients; changes in legislation; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of E-QURE to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, E-QURE Corp. undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting E-QURE, reference is made to E-QURE reports filed from time to time with the Securities and Exchange Commission.
SOURCE E-QURE Corp