Press Release about SprayGel! The names of two surgeons, who perform surgeries at Salt Lake City, Utah, are listed.
June 17, 2002 Confluent Surgical Announces First Procedure In U.S. Trial For SprayGel Adhesion Barrier http://www.confluentsurgical.com/Patient/us_trial.asp
Product Offers Promise of Improved Postoperative Outcomes and Quality of Life for Millions of Women
Waltham, MA – June 17, 2002 – Confluent Surgical, Inc., today announced the commencement of its pivotal U.S. trial for the SprayGel Adhesion Barrier in Prevention of Pelvic Adhesions In Laparoscopic Surgery, the PREVAIL Study. Confluent Surgical believes that the SprayGel Adhesion Barrier will prevent and reduce adhesions that are associated with severe postoperative pain and other side effects, which affect millions of women annually.
The first procedure in the PREVAIL Study was performed last Friday by Michael L. Twede, MD, FACOG, and Dale A. Sundwall, MD, FACOG, Medical Directors at the Salt Lake City Women’s Center. Drs. Twede and Sundwall are considered experts in the treatment of endometriosis and adhesions and are respected as highly skilled surgeons. Dr. Twede states, "Based on the early published results, SprayGel appears to represent a breakthrough in adhesion prevention. It is unique in its ability to be applied laparoscopically and remain in place as a barrier for five to seven days, the period when adhesions normally form. If the results from the initial pilot study are replicated in this pivotal study, this product would prevent or significantly reduce patient trauma and costs associated with additional surgery for adhesions."
Adhesions are fibrous bands of tissue between adjacent organs of the body. They typically occur as a result of inflammation incident to surgery and can cause severe pelvic pain and infertility. Adhesions start to form within three hours of surgery and will cease forming when the surgical sites heal, usually within seven days following surgery. The SprayGel Adhesion Barrier is designed to protect the tissues during this critical healing period. It is estimated that adhesions affect over two million women and men in the U.S. and that the potential U.S. market for abdominopelvic adhesion management is $400-$500 million.
"Based on its early performance in prior pilot trials as well as our early commercial success in Europe, we believe that SprayGel will become the product of choice for gynecologic surgeons to prevent postoperative adhesions," stated Amar S. Sawhney, President and CEO of Confluent Surgical, Inc. " This uniquely adherent, blue polymer gel offers surgeons what they have been lacking in previous products; the ability to see it easily, apply it easily and maintain tissue coverage during the critical days following surgery. We are excited to begin this multicenter pivotal trial as a step towards bringing SprayGel to market in the United States."
About Confluent Surgical, Inc. Confluent Surgical, Inc., is a privately held company developing products based on its platform technologies of in-situ polymerized biomaterials and associated delivery systems. The company believes that its technologies will have applications in major medical markets.
The SprayGel Adhesion Barrier System received CE mark in November 2001, and has been introduced in major European markets and Australia. Based on European and US clinical pilot studies, the patented and proprietary synthetic material has been shown to significantly reduce adhesion formation following abdominopelvic surgery. The SprayGel Adhesion Barrier is not commercially available in the United States.
For additional information please contact Roberta Sawyer at rsawyer@confluentsurgical.com or visit the Confluent's website at http://www.confluentsurgical.com.
JEAN
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