E-QURE has secured approval from the US Food and Drug Administration (FDA) to begin the clinical trial of Bio-electrical Signal Therapy device (BST Device).
The BST device is a new electrotherapy for the non-invasive treatment of hard-to-heal chronic wounds such as pressure ulcers, diabetics foot ulcers, venous stasis ulcers and hard to heal ulcers.
It is currently having few regulatory approvals in different parts of world, and is seeking FDA approval for the device to start marketing it in the US.
The trial is a double arm, controlled, blinded, and placebo study with Sham device, which will assess the safety and efficacy of the BST Device in the half patients with signal and half without the signal.
The FDA granted conditional approval to start clinical trial on the first 10 patients, out of the 90 planned patients for this study.
E-QURE’s report will be filed with the FDA including device’s related adverse events and side effects, after completing the trial with the initial ten patients.
The company will continue the trial with the additional 80 patients to complete treatment in 90 patients, assuming that this report is satisfactory to the FDA.
E-QURE chairman Ron Weissberg said: “The Company is pleased to announce receipt of IDE approval and is looking forward to launch the BST Device trial in the US ASAP."