Halscion has obtained CE mark approval for its Celotres hydrogel scaffold to improve wound healing and the resulting scar consequences following suturing of a wound.
The approval was based on the results of a controlled, multi-center, prospective, randomized, same-patient trial which enrolled female subjects undergoing laparotomy or laparoscopy gynecologic procedures to assess the efficacy of a single application of Celotres in improving wound healing.
Incisions or incision halves were randomized to Celotres treatment or control.
The results as evaluated by both a surgeon observer and the subject herself over 12 months showed that Celotres treated scars were demonstrated as being better than control scars.
Halscion president and CEO Kathleen Beauchamp said the company looks forward to make Celotres available to European physicians this year.
"Celotres will prove an important tool for physicians to consider when managing wound healing and scar outcomes," Beauchamp added.