RICHLAND, Wash., July 6, 2017 /PRNewswire/ -- IsoRay, Inc. (NYSE MKT: 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, today announced that it has received a response from the FDA regarding the Company's pending 510(k) application for the GammaTile™ radiation therapy system.

In its response, the FDA indicated the need for IsoRay, and its co-applicant GammaTile LLC, to submit additional data within the next 180 days as a condition of securing FDA clearance for the novel GammaTile™ device. The GammaTile™ radiation therapy system uses Cesium-131 radiation seeds, exclusively manufactured by IsoRay, that are embedded in a collagen 'tile' and placed in surgical margins at the time of surgery, enabling very high doses of radiation to be precisely delivered to targeted tissue.

As a result of the FDA's response, the pending NTAP (New-Technology Add-On Payment) application, which requires an FDA cleared product, will be resubmitted in the fall of 2017 for the next annual review cycle. IsoRay, and its co-applicant GammaTile LLC, have received ICD-10-PCS coding for the GammaTile™ product which will allow Medicare to implement any reimbursement decisions once the 510(k) has been issued.
"This is a good outcome for the novel GammaTile™ product," said Tom LaVoy, Chairman and CEO of IsoRay. "With the completion of additional testing anticipated by the end of 2017, we project potential 510(k) clearance of the GammaTile™ product in the first half of 2018 which would allow for the NTAP application to be approved in 2018 during the annual review process. GammaTile™ addresses a large unmet clinical need for the treatment of recurrent brain tumors and we're pleased to be advancing on the path to commercialization of this important product."


About the GammaTile™ Radiation Therapy System
The GammaTile™ Radiation Therapy System is a novel system that is a combination of Cesium-131 seeds embedded into collagen tiles, developed and owned by GammaTile LLC, which delivers brain brachytherapy treatment at the time of surgery. GammaTile LLC collaborates with the Barrows Neurological Institute, one of the largest neurological disease treatment and research institutions and consistently ranked as one of the best neurosurgical training centers in U.S. Over 80 patients have been treated in clinical trials with GammaTile™ over the last five years and results point to an extension of the median time to recurrence with a very low rate of side effects.


About IsoRay, Inc.
IsoRay, Inc., through its subsidiary, IsoRay Medical, Inc., is the sole producer of Cesium-131 brachytherapy seeds, which are expanding brachytherapy options throughout the body. Learn more about this innovative Richland, Washington company and explore the many benefits and uses of Cesium-131 by visiting www.isoray.com. Join us on Facebook/IsoRay. Follow us on Twitter@IsoRay.

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