GammaTile Therapy is the Next Step in the Expansion of Cesium to Additional Markets
IsoRay, Inc. (NYSE American: ISR), a medical technology company and innovator in seed brachytherapy and medical radioisotope applications for the treatment of prostate, brain, lung, head and neck and gynecological cancers and GT Medical Technologies, Inc., today announced the receipt of FDA 510(k) regulatory clearance for the brachytherapy technology, known as GammaTile™ Therapy that incorporates proprietary Cesium-131 seeds within customizable collagen-based carriers for the treatment of recurrent brain tumors.
IsoRay Medical, Inc., a wholly owned subsidiary of IsoRay, Inc., and GT Medical Technology had previously executed a collaborative development agreement and an exclusive ten-year supply agreement for GammaTile Therapy. GammaTile leverages Cesium-131’s unique ability to deliver a highly targeted dose of intense radiation treatment while limiting radiation exposure to surrounding tissue. The Centers for Medicare and Medicaid Services (CMS) has already clarified the coding for GammaTile in the hospital setting by assigning GammaTile Therapy to a new, specific ICD-10-PCS code. Now that the FDA has issued regulatory clearance for GammaTile, the therapy can be made available in the near future to patients served by hospitals throughout the United States.