IsoRay (NYSE:ISR) said today it won FDA 510(k) clearance for its GammaTile brachytherapy technology designed for treating recurrent brain tumors.
The Richland, Wash.-based company’s GammaTile is a radiation system using Cesium-131 radiation seeds embedded in a collagen ’tile’ which is designed to be placed in surgical margins at the time of surgery.
IsoRay said it had previously inked a collaborative development and ten-year supply agreement for the newly cleared GammaTile with GT Medical Technologies, which the company said will be available in the US “in the near future.”
“We are very excited that our partnership with IsoRay Medical has resulted in this new opportunity to provide an innovative solution for the hundreds of thousands of patients with recurrent brain tumors. As we worked to gain approval, GammaTile Therapy was implanted in over 100 patients in an IRB- approved study at the Barrow Neurological Institute in Phoenix, AZ. We believe that experience will be a solid foundation for us to expand access to this important advancement in brain tumor therapy,” GT Medical Technologies prez & CEO Matthew Likens said in a prepared statement.
“GammaTile Therapy utilizes Cesium-131 brachytherapy seeds to deliver a fast-acting therapeutic dose to the tumor bed. The unique properties of Cesium-131 have started to revolutionize brain brachytherapy treatment, and GammaTile Therapy should help to accelerate the adoption of these procedures. We look forward to working closely with GT Medical Technologies to support access to this critical treatment for patients with recurrent brain tumors,” IsoRay interim CEO Lori Woods said in a press release.
Last July, IsoRay said that the FDA requested additional data on the company’s 510(k) application for its GammaTile radiation therapy system.
