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www.fdanews.com/articles/81249-angiotech-announces-positive-data-for-adhibit-gel

ANGIOTECH ANNOUNCES POSITIVE DATA FOR ADHIBIT GEL

September 28, 2005

Angiotech Pharmaceuticals has announced positive results from a European clinical study conducted to evaluate the safety and efficacy of Adhibit Adhesion Prevention Gel for the reduction of surgery induced scars (adhesions) that can occur after surgery to remove fibroids from the uterus (myomectomy surgery).

The incidence of patients who suffered from adhesions was 100 percent greater in the group receiving the current standard of care (control group) as compared to the treatment group receiving Adhibit. Safety data also indicated fewer adverse events occurring with the Adhibit group than the control group.

Adhibit is a spray gel applied at the time of surgery that binds directly to the tissue and creates a temporary barrier, preventing contact and adhesions from forming between tissue surfaces. This study was conducted at six investigational sites in Germany, Canada and Curacao. Patients who were scheduled to undergo myomectomy surgery were randomized to either a treatment group that received Adhibit spray at the time of surgery or a control group. Patients then returned eight to ten weeks later for a second-look procedure and were evaluated for both extent and tenacity of adhesion formation.