SAN LUIS OBISPO, California – September 14, 2005 – FzioMed, Inc. announces the presentation of clinical results from multi-center studies demonstrating that Oxiplex/AP significantly reduced the formation of postsurgical adhesions in patients undergoing laparoscopic surgery for treatment of endometriosis. The oral presentation is being made at IX World Congress on Endometriosis held in Maastricht, The Netherlands September 14-17, 2005.
Oxiplex/AP is a synthetic, absorbable gel that is applied during gynecologic surgery to reduce post-operative internal scarring, also known as postsurgical adhesions. Postsurgical adhesions can cause chronic pain, infertility and the need for repeat surgery. Oxiplex/AP can easily be used in both open and laparoscopic procedures.
The presentation “Clinical Evaluation of Endometriosis and Differential Response to Surgical Therapy with and without Oxiplex/AP Adhesion Barrier Gel” reported clinical results from two randomized, blinded studies conducted at leading hospitals in the United States and Europe.
The studies evaluated the effectiveness of Oxiplex/AP in patients undergoing laparoscopic surgery for treatment of endometriosis. The studies also correlated the characterization of endometrial tissue with subsequent formation of adhesions following surgical treatment. The results demonstrated that Oxiplex/AP was effective in reducing adhesion formation compared to surgery alone in all subgroups and, further, included evidence that correlates the extent of adnexal adhesions to color and location of endometriosis.
“Postsurgical adhesions can cause debilitating complications for patients undergoing surgery for endometriosis,” said John Krelle, President and Chief Operating Officer for FzioMed. “Oxiplex/AP is designed to safely reduce the potential for adhesions and improve surgical outcomes for these patients.”
Oxiplex/AP is an investigational product in the United States, where a pivotal clinical trial is ongoing. FzioMed’s adhesion barrier technology is approved in the European Union for spinal, gynecologic and abdominal surgery.
FzioMed is a privately held medical company engaged in the development and commercialization of synthetic, absorbable biomaterials based on the company’s patented Oxiplex technology. FzioMed is developing products for adhesion prevention, tissue augmentation and regeneration, and the delivery of drugs. Oxiplex is an innovative polymer technology with uses in a variety of specialties including orthopedics, gynecology, general surgery, neurosurgery and aesthetic surgery. FzioMed products include Oxiplex/SP, the leading adhesion barrier for spine surgery currently marketed outside of the United States, Oxiplex/AP adhesion barrier for gynecologic and general surgery, and a cosmetic dermal filler.
FzioMed® and Oxiplex® are registered trademarks of FzioMed, Inc.