Halscion Announces European CE Mark Approval of Celotres™ for Wound Healing and Scar Symptoms

Novel Treatment to Improve Wound Healing and the Resulting Scar Consequences Following Suturing of a Wound

SUWANEE, Ga.--()--Halscion, Inc., today announced European CE Mark (EC Certification) approval for its Celotres™ hydrogel scaffold to improve wound healing and the resulting scar consequences following suturing of a wound.

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 in improving wound healing and the resulting scar consequences. One hundred female subjects undergoing laparotomy or laparoscopy gynecologic procedures were recruited to participate in the study. Incisions or incision halves were randomized to Celotres treatment or control. Over 12 months, Celotres treated scars were demonstrated as being significantly better than control scars, as evaluated by both a surgeon observer (p=0.0051) and the subject herself (p=0.0012), using the Patient and Observer Scar Assessment Scale. Statistical significance was also demonstrated by the surgeon observer (p=0.0018) and subject (p=0.0009) when comparing a Celotres treated scar or scar half to control using the Anchored Visual Analog Scale.

“A single application of Celotres just prior to closing the surgical incision demonstrates remarkable effectiveness, from a clinical perspective, in addressing the appearance and characteristics of scarring,” said principal investigator of the study Wlodzimierz Baranowski, M.D., Professor, Department of OB-GYN, Military Medical Institute, Warsaw, Poland. “Given the lack of effective products available to physicians and patients for managing scars and the associated symptoms, I look forward to being able to use Celotres in my clinical practice.”

No serious device-related adverse events were reported with Celotres use. In addition, an evaluation of all reported adverse events demonstrated no difference between treatment and control for any event.

The study’s findings demonstrate Celotres’ safety and efficacy in improving the wound healing process and overall scarring results.

“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. “Celotres will prove an important tool for physicians to consider when managing wound healing and scar outcomes.”

To learn more about Halscion, Inc. and Celotres™, please visit http://www.halscion.net, send email inquiries to info@halscion.net, or contact Allison Potter with Pascale Communications at 412-228-1678 (allison@pascalecommunications.com).

Halscion, Inc. is a privately held company based in Suwanee, Georgia, developing a novel and proprietary hydrogel scaffold to improve wound healing and the resulting scar consequences following suturing of a wound. Celotres is an investigational device, limited by federal law to investigational use in the United States.

Contacts

Pascale Communications, LLC
Allison Potter, 412-228-1678
allison@pascalecommunications.com

Contacts

Pascale Communications, LLC
Allison Potter, 412-228-1678
allison@pascalecommunications.com