FDA Granted E-QURE Approval To Initiate Its US Clinical Trial
11/3/2016 9:12:32 AM
NEW YORK, November 2, 2016 /PRNewswire/ --
E-QURE Corp. (EQUR), a Delaware corporation engaged in the commercialization of its Bio-electrical Signal Therapy device ("BST Device"), a new and novel electrotherapy for the non-invasive treatment of hard-to-heal chronic wounds, today announced that the Company was granted conditional approval by the FDA of its IDE application for conducting its US clinical trial.
The IDE (investigational device exemption) was approved by the FDA as a pre-condition to initiating the clinical trial on the first 10 patients, out of the 90 planned patients for this trial, after which a safety report will be submitted to the FDA, ensuring no severe safety issues were found. The Company will then continue the trial to complete all 90 patients in the trial.
E-QURE's Clinical trial is designed to be Double Arm, Controlled, Blinded, Placebo with Sham device, testing the safety and efficacy of the BST Device, by treating 90 patients, half of which with signal and half without. The Company will start the trial with 10 patients within the trial protocol. After completing the trial with the initial ten patients, the Company's report will be filed with the FDA describing all device related adverse events and side effects, if any. Assuming that this report is satisfactory to the FDA, the Company will continue the trial with the additional 80 patients to complete treatment in 90 patients.
Ron Weissberg, Chairman of E-QURE Corp., commented. "The Company is pleased to announce receipt of IDE approval and is looking forward to launch the BST Device trial in the US ASAP."
E-QURE Corp (EQUR) develops, manufactures and markets the E-QURE BST (Bioelectrical Signal Therapy) Device for the treatment and cure chronic wounds such as; pressure ulcers; diabetics foot ulcers; venous stasis ulcers and; hard to heal ulcers. The E-QURE BST device had few regulatory approvals in different part of the world that is currently being renewed. The company is seeking FDA approval for the device to start marketing it in the US.
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, ADBI 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.
Investor Relation Manager
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