SAN LUIS OBISPO, California - June 9, 2004 - FzioMed, Inc. today announced that the Company completed its United States pilot clinical trial of Oxiplex/AP Gel, an adhesion barrier for laparoscopic gynecological surgery. The randomized, multi-center trial was conducted to determine the safety of Oxiplex/AP Gel for the reduction of postoperative adhesions following laparoscopic gynecological surgery. FzioMed submitted the final results to FDA last week. The Company is seeking the agency's agreement to initiate a pivotal clinical trial.

The majority of patients undergoing gynecological surgery will develop post-surgical 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 as well as small bowel obstruction. Oxiplex/AP Gel is an absorbable, synthetic gel that coats tissues and acts as a barrier to adhesion formation.

"Oxiplex/AP Gel is designed to satisfy the significant need for an effective adhesion barrier that is safe and economical," said Ronald Haynes, President and CEO of FzioMed. "These factors can position Oxiplex/AP for routine use in laparoscopic gynecologic surgery and help improve the outcomes of these procedures."

FzioMed is already conducting a pivotal clinical trial in the U.S. of its Oxiplex/SP Adhesion Barrier Gel in spine surgery. The Company plans to initiate clinical trials of Oxiplex/AP Gel in general surgery later in 2004.

Outside the U.S., FzioMed has received CE Mark approval in the European Union for its Oxiplex adhesion barrier technology in spine, gynecological and abdominal surgery. The Company began selling Oxiplex/SP Gel for spine surgery in the E.U. in 2002 and plans to launch Oxiplex/AP Gel for laparoscopic gynecological surgery in the E.U. in 2004.

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 products include Oxiplex/SP, the leading adhesion barrier for spine surgery, currently marketed outside the United States. Other FzioMed products are in various stages of development and commercialization, and are directed towards high growth markets in the rapidly growing field of biosurgery materials.

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

Back to News Articles