Suwanee, Ga. — Drugmaker Halscion announced that its product Celotres has received European CE mark approval. Celotres is a hydrogel scaffold used to improve wound healing and scarring.
Celotres received the CE mark approval based on the successful results of European clinical trials. The trials were conducted among 100 female patients undergoing laparotomy or laparoscopy gynecologic procedures, and showed that after 12 months, the scars treated with Celotres were evaluated by both observers and subjects as appearing significantly better using both the Patient and Observer Scar Assessment Scale and the Anchored Visual Analog Scale.
There were no serious device-related adverse events reported with Celotres use and an evaluation of all adverse events showed no difference between treatment and control for any event.
“We are pleased to reach this significant milestone for Halscion and look forward to making Celotres available to European physicians this year,” said Kathleen Beauchamp, president and CEO of Halscion.
The CE mark shows that a product conforms to consumer laws for the entire European Economic Area and allows a product to be sold among all nations in the confederation.
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