AAOS MEETING: Adcon-L Improves Scar Healing And Pain After Back Surgery
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AAOS MEETING: Adcon-L Improves Scar Healing And Pain After Back Surgery

NEW ORLEANS, CA -- March 19, 1998 -- New clinical findings presented at the American Academy of
Orthopaedic Surgeons Annual Meeting show that Gliatech Inc.’s Adcon(R)-L provides significant clinical utility. A clinical utility index was used to determine the product's clinical success and benefit to the patient.

Adcon-L is a carbohydrate polymer gel designed to provide a physical barrier to postoperative adhesions involving the spinal cord and nerve roots. Postsurgical adhesions occur when tissues bind together, causing a compression or tethering of the nerve root.

Patients treated with Adcon-L demonstrated significantly better clinical utility scores than the control patients. The clinical utility index is a composite measure (score) assigned to each patient based on the amount of non-extensive scar and improvement in all clinical outcome measurements used in Gliatech's clinical trials.

"These positive clinical utility scores further validate the importance of Adcon-L for both patients and surgeons," said Richard Guyer, M.D., director, Institute for Spine and Biomedical Research, Texas Back Institute, Plano, TX. "Adcon-L has now set the benchmark for determining effectiveness in the area of surgical adhesion prevention."

Additional findings presented at the meeting included:

-- There is a significant association between extensive scar and clinical outcome.
-- Adcon-L significantly reduced the incidence of postsurgical scarring and adhesions.
-- Adcon-L improved patient outcome by reducing activity-related pain and low back pain as compared to the control group.
-- Adcon-L patients had greater pain-free range of motion as measured by the straight leg raise exam.
-- Adcon-L had an excellent safety profile with no significant adverse events attributed to the product.

"Postsurgical adhesions following back surgery are one of the leading causes of recurrent back pain," said Thomas Oesterling, president and chief executive officer of Gliatech. "Adcon-L is the first product shown in a controlled clinical study to reduce postsurgical adhesions and postoperative activity-related pain after back surgery. We look forward to bringing this important new product to the U.S. market once the United States Food and Drug Administration’s approval process is complete."

Adcon-L is currently available in 29 countries and has been used in over 10,000 surgeries. In December 1997, the product was recommended for approval in the U.S. with conditions, primarily regarding labelling, by the orthopaedics and rehabilitation devices advisory panel to the F.D.A.

More information on: Gliatech Inc. and Adcon-L.

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