Chronic wound treatment device developer E-Qure said today it won FDA approval to expand and launch a pivotal trial of its Bio-electrical Signal Therapy Device chronic wound treatment device.
The New York-based company said its Bio-electrical Signal Therapy device is designed for non-invasively treating hard-to-heal chronic wounds, including pressure ulcers, diabetic foot ulcers, venous stasis ulcers and other hard to heal ulcers.
E-Qure said it won conditional approval in October 2016 to conduct the safety stage of the trial, and that the FDA approved a request to increase the number of institutions in the safety stage set to treat the 1st 10 patients from 1 to 5.
With the request approved, the company said it will be able to “dramatically shorten the safety portion of the trial” which will allow it to accelerate the timeline to treat all 90 patients in the trail.
“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,” board chair Ron Weissberg said in a press release.
E-Qure said it may request approval to expand enrollment to 90 patients following its IDE supplement submission.