SAN LUIS OBISPO, California – October 13, 2006 – FzioMed, Inc. announced today reports of positive clinical experiences by European surgeons using the company’s adhesion barrier gel to prevent postoperative adhesions from forming after back surgery. Presentations are being made at annual meetings of the Congress of Neurological Surgeons (CNS) in Chicago this week and at the upcoming European Spine Society’s Annual Meeting (EuroSpine) to be held October 25-28 in Istanbul, Turkey.
FzioMed’s adhesion barrier is an injectable, absorbable gel, in a 3mL syringe, for use in reducing the incidence, extent and severity of postsurgical adhesions following lumbar spine surgery. Postsurgical adhesions are abnormal bands of scar tissue that can form between tissues following surgery and cause postoperative complications such as recurrent back pain and weakness.
The gel is placed in the epidural space during laminectomy, laminotomy, and discectomy procedures to separate tissues and act as a temporary, protective barrier against adhesion formation. The product is marketed outside the United States as MediShieldT Anti-Adhesion Gel and as Oxiplex®/SP Adhesion Barrier Gel. FzioMed is completing a pivotal clinical trial of Oxiplex/SP in the U.S.
The presentation, “Use of a Novel Gel-Formulated Anti-Adhesion Barrier for Prevention of Fibrotic Adhesions in Lumbar Micro-discectomy Procedures,” at both CNS and EuroSpine, describes a controlled study comparing a gel-treated group of patients to a control group of patients who received no gel. No or negligible scar tissue was evidenced in 73.5% of patients treated with gel compared to significant scarring noted in 79.9% of controls. There were no complications or allergic reactions related to the gel.
A presentation at CNS titled, “Clinical Experience with the Use of MediShield Gel for the Prevention of Peridural Fibrosis,” describes a controlled study comparing a gel-treated group of patients to a control group of patients who received no gel, in which the gel provided a significant protective effect against recurrent sciatica in patients with and without recurrent disc herniation. There were no complications related to the gel.
FzioMed is a medical company developing and commercializing absorbable, surgical biomaterials based on the company’s patented Oxiplex science. Oxiplex is an innovative medical polymer technology 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 LaresseT cosmetic dermal filler. FzioMed products are for investigational use only in the U.S. Go to www.fziomed.com
FzioMed®, Oxiplex® and Laresse® are registered trademarks of FzioMed, Inc., and MediShieldT is a trademark of Medtronic Sofamor Danek.