SAN LUIS OBISPO, California – May 9, 2006 – FzioMed, Inc. announced today the presentation of preclinical studies demonstrating that the company’s Oxiplex Gel was effective in reducing perivascular adhesions in artificial disc surgery. The poster presentation is being made at the Spine Arthroplasty Summit 6 (SAS6) of the Spine Arthroplasty Society held in Montreal, Quebec, Canada May 9 – 13, 2006.
Revision of an artificial disc procedure poses unique challenges. The anterior approach of the second surgery can be severely complicated by adhesions that have formed around vessels, nerves and ureter following the initial surgery. Adhesions can be so dense that they obstruct identification of individual structures and significantly increase the risk of vessel injury.
Oxiplex Gel is an absorbable, injectable gel developed by FzioMed for use in preventing internal scar tissue, called adhesions, from forming after surgery. The gel is designed to be applied during surgery, act as a temporary barrier to adhesion formation, and then clear naturally from the body.
The preclinical studies compared the effectiveness of Oxiplex Gel in preventing perivascular adhesions after retroperitoneal spine surgery to that of a control group that underwent the same procedure without use of the gel. The results showed that coating the vessels with Oxiplex Gel during the initial surgery significantly simplified dissection in revision surgery by reducing both density and tenacity of adhesions. By contrast, extensive adhesions formed in all controls, between the overlying peritoneum, between the abdominal aorta and underlying vessels and muscles, and between the muscle and spinal column.
“Oxiplex Gel could be artificial disc surgery’s best friend,” said John Krelle, President & COO of FzioMed. “Anterior access spine arthroplasty is on the rise and yet questions remain as to how to reduce the risks associated with adhesions around the great vessels when performing revision surgery. An easy to use, effective adhesion barrier gel like Oxiplex could be the simple answer.”
FzioMed is a privately held medical company developing and commercializing synthetic, absorbable biomaterials based on the company’s patented Oxiplex technology. Oxiplex is an innovative absorbable polymer with uses in a variety of specialties including orthopedics, spine, gynecology, general surgery 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 Laresse cosmetic dermal filler. Oxiplex products are for investigational use only in the U.S.
FzioMed® and Oxiplex® are registered trademarks of FzioMed, Inc.