SAN LUIS OBISPO, California – November 28, 2005 – FzioMed, Inc. announced today the publication of positive results from a U.S. clinical trial of Oxiplex/AP for adhesion prevention in laparoscopic gynecological surgery. The peer-review article “Reduction of Postoperative Adhesions Following Laparoscopic Gynecological Surgery with Oxiplex/AP Gel: A Pilot Study” was published in the November 2005 issue of Fertility and Sterility Journal (Volume 84, Issue 5, pages 1450-1456).
Most patients undergoing pelvic reconstructive surgery will develop post-operative adhesions – scar tissue that can form inside the body after surgery. Postsurgical adhesions can cause chronic pain, infertility and the need for repeat surgery. Oxiplex/AP is an absorbable, synthetic gel designed to coat tissues during surgery and act as a barrier to adhesion formation.
The Fertility and Sterility article reported results from FzioMed’s randomized, double-blinded, multi-center pilot clinical trial of Oxiplex/AP in the United States. The trial was designed to study the safety and preliminary effectiveness of Oxiplex/AP as an adhesion prevention device for women undergoing conservative gynecological surgery by laparoscopy. The results of this study demonstrated that Oxiplex/AP was safe, easy to apply, and provided clinically significant, site-specific reduction in adhesion formation when applied to adnexal surfaces.
“Millions of women each year undergo pelvic surgery and we know from clinical literature that more than half of these procedures could be complicated by adhesions,” said John Krelle, President and Chief Operating Officer of FzioMed. “This study showed that Oxiplex/AP could be easily applied during laparoscopic surgery to safely reduce the potential for adhesion-related complications.”
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.