IsoRay gets FDA clearance for brain cancer therapy

Richland, WA-based IsoRay has obtained FDA clearance for its GliaSite radiation therapy system, a balloon catheter device used to treat brain cancer. The clearance paves the way for the GliaSite system's return to the marketplace.

Brain cancer is notoriously tricky to treat. When operating on the cancer, surgeons remove as much of the tumor as they can and then treat surrounding areas with radiation therapy. However, most cancerous brain tumors recur shortly following removal near the site of the original tumor. With the GliaSite system, a specified high dose of a liquid radiation source is placed in the areas most likely to contain cancer after brain tumor removal. This form of radiation is less likely to damage healthy brain tissue than other alternatives, and the ability for the tumor to recur is greatly diminished, according to the company.

The GliaSite technology was originally developed by Proxima Therapeutics and initially obtained FDA clearance in 2001. In 2005, Proxima was bought by Cytyc, which in turn merged with Hologic ($HOLX) in 2007. Hologic stopped marketing GliaSite in 2008. IsoRay finalized a license agreement with Hologic for exclusive worldwide distribution rights to the GliaSite system in June 2010.

IsoRay CEO Dwight Babcock sees the return of GliaSite as way to expand treatment to effectively treat brain cancer. "With our sales launch expected in the fourth quarter, we know there is great interest and a growing number of inquiries from the marketplace. We are already hearing from doctors who are anxious to access this leading-edge technology to treat their patients and give them more choices," he said in a statement.

- see the IsoRay statement