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.
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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SOURCE IsoRay, Inc.