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News Release - July 6, 2017
IsoRay Receives FDA Response to 510(k) Application for GammaTile(TM)Additional Testing for GammaTile™ Planned for Completion by Year-End 2017
RICHLAND, Wash., July 6, 2017 -- (Healthcare Sales & Marketing Network) -- 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.
Safe Harbor Statement
Statements in this news release about IsoRay, Inc.'s future expectations, including: timing of the additional data required to be submitted, the timing of completion of additional testing, the ultimate clearance and timing of the clearance of the 510(k), the ultimate approval of the NTAP application and the timing of the approval, the timing and ultimate commercialization of the product, and all other statements in this release, other than historical facts, are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 ("PSLRA"). This statement is included for the express purpose of availing IsoRay, Inc. of the protections of the safe harbor provisions of the PSLRA. It is important to note that actual results and ultimate corporate actions could differ materially from those in such forward-looking statements based on such factors as whether the FDA will seek additional data after the submission, the success and timing of completion of the testing needed to support the submission, the review by and timing of approval of the FDA, the review and timing of Medicare implementation of NTAP decisions, the development of competitive products to the GammaTile™ products before approval, physician acceptance, training and use of our products, our ability to successfully manufacture, market and sell our products, our ability to manufacture our products in sufficient quantities to meet demand within required delivery time periods while meeting our quality control standards, our ability to enforce our intellectual property rights, whether additional studies are released and support the conclusions of past studies, whether ongoing patient quality of life results with our products are favorable and in line with the conclusions of clinical studies and initial patient results, patient results achieved when our products are used for the treatment of cancers and malignant diseases in conjunction with other treatments, the coding process in 2018, successful completion of future research and development activities, whether we, our distributors, and our customers will successfully obtain and maintain all required regulatory approvals and licenses to market, sell, and use the GammaTile™ products in its various forms, continued compliance with ISO standards as audited by BSI, the success of our sales and marketing efforts, changes in reimbursement rates, changes in laws and regulations applicable to our products, and other risks detailed from time to time in IsoRay, Inc.'s reports filed with the Securities and Exchange Commission. Unless required to do so by law, the Company, IsoRay, Inc. undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.
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