FDA Awards Clearance to Reapplix’s 3C Patch System

Reapplix has won 510(k) clearance for its 3C Patch System, which prepares platelet-rich plasma gel from a patient’s own peripheral blood.

The gel is designed to manage exuding cutaneous wounds, including leg, pressure or diabetic ulcers, as well as mechanically or surgically debrided wounds.

The company adds that it is conducting a randomized, controlled study in about 250 diabetic foot ulcer patients in centers in the UK, Sweden and Denmark. It expects data from the study next year. — Anisa Jibrell