IsoRay Granted FDA Clearance for GammaTile Therapy

IsoRay Inc., an 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., have received U.S. Food and Drug Administration (FDA) 510(k) regulatory clearance for brachytherapy technology known as GammaTile Therapy. The therapy 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 10-year supply agreement for GammaTile Therapy.  GammaTile leverages Cesium-131’s 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.
 
The new technology add-on (NTAP) program would qualify us for additional payments in the inpatient hospital setting under Medicare beyond what is currently available. However, the date of the FDA clearance will not qualify for the current NTAP application cycle. Therefore, GammaTile will need to re-submit for consideration under the NTAP program for fiscal year 2020, which begins on Oct. 1, 2019.
 
“We are very excited that our partnership with IsoRay Medical has resulted in this new opportunity to provide a solution for the hundreds of thousands of patients with recurrent brain tumors,” said Matthew E. Likens, president and CEO of GT Medical Technologies. “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, Ariz. We believe that experience will be a solid foundation for us to expand access to this important advancement in brain tumor therapy.”
 
“GammaTile Therapy utilizes Cesium-131 brachytherapy seeds to deliver a fast-acting therapeutic dose to the tumor bed,” said Lori Woods, interim CEO of IsoRay. “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.”
 
GT Medical Technologies Inc., a privately held company based in Arizona, has developed a proprietary approach, protected by 10 issued U.S. patents and a number of foreign equivalents, for the treatment of brain tumors by combining a conformable collagen matrix with Cesium-131 seeds. In December 2017, the company completed a multi-million-dollar seed round of investment capital financing led by MedTech Venture Partners, and was awarded an Arizona Innovation Challenge grant in the amount of $250,000.
 
IsoRay Inc., through its subsidiary, IsoRay Medical Inc. is the sole producer of Cesium-Blu brachytherapy seeds, which are expanding brachytherapy options throughout the body. The company is based in Richland, Wash.