By Lisa Seachrist
Integra LifeSciences Holdings Corp. received marketing clearance for its dura mater graft matrix, DuraGen, for restoring the dura mater following neurosurgical and spinal procedures.
With a recent product launch in Europe under its belt, Plainsboro, N.J.-based Integra will use its wholly owned subsidiary, Integra NeuroCare, to make DuraGen available for use by U.S. surgeons within the next month.
"We are all very upbeat following this news," said Simon Archibald, vice president for research and development for Integra NeuroCare. "This product allows surgeons to restore the dura mater and will be very competitively priced with other agents currently marketed."
The dura mater is a tough connective tissue that surrounds the brain and spinal cord. It basically is a sac containing the cerebrospinal fluid that bathes the central nervous system. Damage to the dura mater - either through surgery or trauma - can lead to spinal fluid leakage, causing severe headaches and possibly infection.
DuraGen is a type I collagen matrix that comes in sheets and is used for restoration of the dural membrane. The matrix provides a framework for fibroblasts to grow and close the tear in the dura mater. As the membrane is restored, the matrix is resorbed by the body.
In determining whether to approve DuraGen, the FDA considered a 1,096-patient study that showed DuraGen's infection rate was comparable to other synthetic products of human and animal origin that are used for dura mater repair. In addition, the study showed the collagen matrix was completely replaced with endogenous tissue within eight to 12 months after implantation, and that patients who received DuraGen were unlikely to experience cerebrospinal fluid leakage.
The company estimated there are 97,000 dural graft procedures each year in the U.S. and that, worldwide, the market for dural graft implantation is approximately $40 million. The company now has approvals in the U.S. and Europe, and is preparing to begin the regulatory process in Japan.
"We are already shipping in Europe, since we received approval in January," Archibald said. "We are initiating clinical trials for Japanese approval. Those trials will be conducted in Canada."
Archibald said that the product would range in cost from $275 for a 2-inch square of DuraGen to $800 for a piece of material 4 inches by 5 inches.
Integra's stock (NASDAQ:IART) closed at $8.75 Thursday, up 50 cents a share.