FDA panel rejects LifeCore's surgical adhesion gel
ROCKVILLE, Md. Jan 12 (Reuters) - A federal advisory panel Wednesday rejected LifeCore Biomedical Inc.'s (NasdaqNM:LCBM - news) Intergel, a product designed to reduce internal scarring after gynecological surgery.
A Food and Drug Administration advisory committee voted 5 to 2 to recommend that the agency turn down LifeCore's application to sell the product in the United States. Panelmembers said they were not convinced that LifeCore's studies showed Intergel provided a meaningful benefit.
``From a clinical standpoint, I think we're hard pressed to say this device makes a difference,'' said panel member Dr. Barbara Levy of Yale University School of Medicine.
Intergel is viewed as a key product for LifeCore's future growth, company officials and analysts have said. Intergel was designed to reduce the incidence and severity of post-surgical internal scars, which can be painful and cause problems years later.
The FDA usually follows its panels' advice.