FzioMed’s Adhesion Barrier, Oxiplex/AP® Gel, Reduces Extent and Severity of Adhesions After Gynecologic Surgery

SAN LUIS OBISPO, California – November 24, 2003 – FzioMed, Inc. will present clinical data of its Oxiplex/AP Gel, Adhesion Barrier for Abdominal/Pelvic Surgery, at the Annual Congress of the European Society of Gynaecological Endoscopy being held November 26 – 29, 2003 in Luxembourg. Richard Berg, PhD., Vice President of Research and Development, will present results indicating that Oxiplex/AP Gel is well tolerated in patients and reduces the formation of adhesions following gynecologic surgery.

The majority of patients undergoing gynecologic surgery will develop post-operative adhesions: abnormal bands of scar tissue that can form inside the body after surgery. Post-surgical 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.

“Adhesions form in the vast majority of women following gynecologic surgery, creating a significant health issue that is largely underserved,” said Ronald Haynes, President and CEO of FzioMed. “These results show that Oxiplex/AP Gel can fill the market need for a safe and economical product, that can be delivered via a laparoscope, and prevent this surgical complication.”

Dr. Berg’s presentation “Inhibition of Post-Surgical Adhesion Reformation by Oxiplex Adhesion Barrier Gel” will include clinical data from studies of Oxiplex/AP Gel conducted in Europe. Study objectives were to evaluate the handling and performance of Oxiplex/AP Gel in patients undergoing conservative gynecologic surgery. Study results demonstrate that Oxiplex/AP Gel was well tolerated by patients and easy to apply by laparoscopy. Patients that received Oxiplex/AP Gel during surgery had a reduced extent and severity of de novo and reformed adhesions compared to patients who did not receive the gel, as demonstrated by a significant reduction in American Fertility Society (AFS) score.

A pilot clinical trial of Oxiplex/AP Gel is underway in the United States. The product has received CE Mark approval in the European Union. FzioMed plans to launch Oxiplex/AP Gel in Europe in 2004.

FzioMed is a privately held biomedical company engaged in the development and commercialization of advanced, absorbable biosurgery products based on the company’s patented Oxiplex platform technology. Oxiplex is an innovative polymer material that is formulated for a variety of indications including post-surgical adhesions, drug delivery and hemostasis. FzioMed’s Oxiplex/SP is the leading adhesion barrier gel for spine surgery. Other FzioMed products are in various stages of commercialization and development, and are directed towards high growth markets in the rapidly growing field of biosurgery.

FzioMed® and Oxiplex® are registered trademarks of FzioMed, Inc.