Posted by Article on 4/2/2002, 10:36 am

Confluent Surgical, Inc. Announces Results of SprayGel(TM) Adhesion Barrier System U.S. Pilot Clinical Trial WALTHAM, March 1 /PRNewswire/ -- Confluent Surgical Inc. disclosed the results of its U.S. pilot clinical trial of its lead product, SprayGel(TM) Adhesion Barrier at the VIIth World Congress on Endometriosis in San Diego. 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 pilot clinical study was conducted at two clinical sites in the U.S., and consisted of 14 randomized patients undergoing surgery for removal of endometriosis and adhesions on the uterine adnexa, such as the ovaries and fallopian tubes. The endpoints of the internally controlled clinical trial examined the reduction in incidence and extent of adhesions to the adnexa. The incidence of adhesion formation to the SprayGel treated adnexa was found to be 71% reduced at the time of second look surgery, over that of the contralateral control adnexa, relative to initial surgery. The extent of adhesion formation was reduced by 69%. Both differences were found to be statistically significant (p <0.05). "I was impressed by the level of performance that we saw with SprayGel in this group of patients that underwent extensive surgery for advanced endometriosis and presence of adhesions. I have been involved in many clinical trials for adhesion prevention to date, and I find the approach that SprayGel takes to solving this problem as a very promising one. I am looking forward to participating in the Pivotal Clinical study for this exciting product," said Dr. Alan Johns of the Texas Institute for Clinical Research, who was the principal investigator for the SprayGel study. Dr. Johns is also the President Elect of the American Association of Gynecological Laparoscopists. "This is an important milestone for Confluent, in the development of what promises to be the first truly effective therapeutic approach for the prevention of post-surgical adhesions. Adhesions formed as a result of endometriosis surgery and re-formation of adhesions to the ovaries and fallopian tubes are a huge problem. We are very excited by these initial results of SprayGel's strong efficacy in adhesion prevention in these procedures, which adds to the results we have previously seen in Uterine surgery from our European clinical trials," 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., liqht or heat source). SprayGel is sprayed onto tissues using an air-assisted sprayer that can be used in either laparoscopic or open laparotomy 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 has received the CE mark and is currently commercially available in select European countries. SprayGel is not currently approved for sale in the U.S. Confluent Surgical, Inc. is a privately held medical device company, 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 and Tissue Sealing. For more information, please visit http://www.confluentsurgical.com

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