By Randall Osborne
Gliatech Inc. said the FDA approved its ADCON-L anti-scarring gel for lumbar surgery,which the company expects to launch in June.
Maryellen Callanan, spokeswoman for Cleveland-based Gliatech, declined comment, citingthe "quiet period" rules of the Securities and Exchange Commission. The companyregistered on May 15 for a public offering of 2 million shares.
Gliatech's stock (NASDAQ:GLIA) closed Thursday at $18.75, up $0.687. At that price,the offering would raise $37.5 million, excluding an unspecified overallotment option.
ADCON-L is a carbohydrate polymer gel that provides a physical barrier to post-surgicalscarring and adhesions involving the spinal cord and nerve roots.
In the U.S., more than 400,000 lumbar disc surgeries are performed annually. Scarringafter back surgery, peridural fibrosis, is considered an important cause of post-surgicalback pain, developed by up to 40 percent of patients.
Also, scarring can obscure the nerve root, making subsequent surgery difficult for thesurgeon and dangerous to the patient.
ADCON-L, classified as medical device, won an FDA advisory panel's backing lastDecember, and Gliatech received an approvable letter related to the product from theagency in April. (See BioWorld Today, Dec. 15, 1997, p. 1, and April 10, 1998, p.1.)
All of Gliatech's ADCON-L trials were related to the lumbar surgery indication.
The gel is applied after surgery, coating the area near nerve roots in the spine. It inhibitsscarring and adhesions, and is naturally absorbed by the body in about four weeks.
Gliatech was allowed to say the gel "reduces activity-relatedpain as compared to the control group."
Cost To Run About $500 Per Surgery
Estimated cost of ADCON-L is $495 per unit, with one unit indicated per surgery.
Gliatech's anti-adhesion product fared better with the FDA than Cambridge, Mass.-basedGenzyme Corp's Sepracoat, designed to prevent abdominal scarring. An FDA advisorypanel, citing unimpressive clinical data, turned thumbs down on the hyaluronic acidsolution last year. (See BioWorld Today, May 6, 1997, p. 1.)
Already on the market, however, is a related product, Genzyme's Seprafilm, which is abioresorbable membrane that acts as a barrier to prevent adhesions to tissues at the site ofincision. Sepracoat was designed to bathe the abdominal cavity to prevent de novoadhesions in areas just beyond the incision.
Gliatech's public offering will be managed by Cowen & Co., of New York; FurmanSelz, also of New York; and Vector Securities International Inc., of Deerfield, Ill.
As of March 31, Gliatech had $8 million in cash, with a net loss of $2.1 million for thequarter. *