September 6,2000

Confluent Surgical, Inc. Begins SprayGelT Adhesion Barrier System Clinical Trial


BOSTON, Nov. 30 /PRNewswire/ - -Confluent Surgical Inc. announced today that the Company has begun a clinical trial for the SprayGelT Adhesion Barrier System.

SprayGel is designed to reduce or eliminate adhesions after gynecological surgery. Adhesions are a leading cause of pain, infertility, and other complications following such surgery. The study is being conducted at two clinical sites in Europe, and will include up to 50 patients undergoing surgery for removal of uterine fibroid tumors (myomectomy). The clinical endpoint of the clinical trial will be the reduction or elimination of adhesions to the uterus.

"We are pleased to have attained this important milestone in the development of what promises to be first truly effective therapeutic approach for the prevention of post-surgical adhesions" said Amar Sawhney, Ph.D., Founder, President, and CEO of Confluent.

Based on proprietary hydrogel technology, SprayGel consists of two synthetic liquids that when mixed together rapidly cross-link to form an absorbable biocompatible hydrogel in situ, at the application. The polymerization occurs very rapidly (within seconds) with no heat evolved and no external energy source required (e.g., light or heat source). SprayGel is sprayed onto tissues using an air-assisted sprayer that can be used in either laparoscopic or open procedures. The hydrogel forms a flexible adhesion barrier that is tightly adherent to tissue, remains intact for about a week, and is then absorbed. This allows surgically injured tissues to heal without forming a scar or adhesion with surrounding organs.

"SprayGel is a breakthrough in adhesion barriers because it can be easily applied laparoscopically and remains on the tissues where it is applied during the critical wound healing period." Said Dr. Alain J.M. Audebert, Gynecologic Surgeon, Institut Robert B. Greenblatt, Bordeaux, France

Confluent Surgical, Inc. is a privately held medical device company formed in 1998, that is focused on developing in-situ polymerized biomaterials to address unmet or under served clinical needs associated primarily with the prevention of Post Surgical Adhesions.




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