EU awards CE mark approval for VergenixFG in chronic and acute wound healing- CollPlant

CollPlant has received its CE Mark for VergenixFG (human collagen scaffoled), a flowable gel intended to treat chronic and acute wounds. The approval is based on clinical trial results which demonstrated that VergenixFG is safe and effective for use on human subject and shows excellent wound closure rates.

The 20 patient, open, single arm trial was conducted at a number of wound clinics within Israel. The trial objective was achieved, demonstrating the safety of VergenixFG and its performance in patients with chronic, hard to heal lower limb ulcers. All patients in the trial received a one-time treatment with VergenixFG, followed by a four-week follow-up. Product performance was examined according to several indicators, including the percentage of wound closure achieved. Trial final results demonstrated that VergenixFG is safe and effective for use on human subjects. Of note, in all 20 patients treated, final results show average wound closure rates of 80%. Full wound closure was observed in nine of the 20 patients (45% of the patients) after four weeks following the single administration, and the median was 94% wound closure.