Celotres Earns CE Mark Approval for Wound Healing

European regulators have granted CE Mark approval for Celotres™ hydrogel scaffold from Halscion, Inc. The CE Mark approval was based on the results of a prospective, multi-center, randomized, same-patient controlled, European clinical trial evaluating the efficacy of a single application of Celotres for improving wound healing and resulting scars. The study involved 100 female subjects undergoing laparotomy or laparoscopy gynecologic procedures. Incisions or incision halves were randomized to Celotres treatment or control. Over 12 months, Celotres treated scars were evaluated by both a surgeon observer (p=0.0051) and the subject herself (p=0.0012, using the Patient and Observer Scar Assessment Scale) as better than the control scars. Surgeon observer (p=0.0018) and subject (p=0.0009) comparison of Celotres-treated scar or scar half to control was statistically significantly in favor of Celotres using the Anchored Visual Analog Scale. There was no difference in adverse events between the active treatment and control groups, and there were no serious adverse events reported.