Chronic wound treatment device developer E-Qure said today it won FDA investigational device exemption approval to conduct a clinical trial of its novel Bio-Electrical Signal Therapy 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.
A U.S. trial of the device is slated to enroll 90 patients, with a required safety report set to be delivered after initiating the 1st 10 patients to protect from any severe safety issues. The trial will test the device against a sham device cohort.
“The company is pleased to announce receipt of IDE approval and is looking forward to launch the BST Device trial in the US ASAP,” chair Ron Weissberg said in a press release.
