SAN LUIS OBISPO, California – October 13, 2004 – FzioMed, Inc. announces the presentation of positive clinical results of its Oxiplex/AP Gel, an adhesion barrier for laparoscopic gynecological surgery. The oral presentation will be made at the 13 th Annual Congress of the European Society of Gynaecological Endoscopy being held October 14 – 17, 2004 in Cagliari, Italy.
The majority of patients undergoing gynecological surgery will develop post-operative adhesions: abnormal bands of scar tissue that can form inside the body after surgery. Postsurgical adhesions can cause infertility and/or chronic pelvic pain. Oxiplex/AP Gel is an absorbable, synthetic gel that coats tissues and acts as a barrier to adhesion formation.
“The ideal adhesion barrier should be effective, economical and easy to apply,” said Ronald Haynes, President and CEO of FzioMed. “We are offering a product that can improve surgical outcomes for the millions of women each year who undergo pelvic surgery that could be complicated by adhesions.”
The oral presentation “Reduction of Adhesions Following Laparoscopy with Oxiplex/AP Gel” will include clinical data from a randomized, blinded, parallel-group post-market study of Oxiplex/AP Gel conducted in four leading hospitals in Europe. Study objectives were designed to evaluate the performance of Oxiplex/AP Gel in patients undergoing laparoscopic gynecological surgery. Study results demonstrated that Oxiplex/AP Gel was well tolerated by patients and easy to apply by laparoscopy. Patients with and without endometriosis who received Oxiplex/AP Gel during surgery had reduced adhesion formation as compared to patients who did not receive the gel, as demonstrated by statistically significant reduction in American Fertility Society (AFS) adhesion scores.
FzioMed’s Oxiplex adhesion barrier technology is approved in the E.U. for spinal, gynecological and abdominal surgery. FzioMed began selling Oxiplex/SP Gel for spine surgery in the E.U. in 2002, and plans to launch Oxiplex//AP Gel for gynecological and abdominal surgery in the E.U. A clinical trial of Oxiplex/AP is ongoing in the United States.
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 the prevention of post-surgical adhesions, for tissue healing and augmentation, and for the delivery of drugs. Oxiplex is an innovative polymer technology with potential uses across a wide variety of specialties including orthopedics, gynecology, general surgery, cardiac, neurosurgery and aesthetic surgery.
FzioMed® and Oxiplex® are registered trademarks of FzioMed, Inc.