MONONA, Wis.–(BUSINESS WIRE)–SHINE Medical Technologies, Inc., a Wisconsin-based company dedicated to
being the world leader in the safe, clean, affordable production of
medical tracers and cancer treatment elements, announced today that the
staff of its primary regulator, the Nuclear Regulatory Commission (NRC),
has completed their safety and environmental reviews and recommends
approval of a Construction Permit for the SHINE facility. SHINE is the
first U.S. medical isotope producer to have reached this stage of the
NRC permitting process since the 1960s.
The review process culminated in the issuance of three documents, each
concluding that the SHINE medical isotope production facility is safe to
construct and recommending that SHINE be issued a Construction Permit.
SHINE now enters the final stage of the construction permitting process,
which includes a hearing with the NRC Commissioners.
“This is the first time in over fifty years a medical isotope plant has
been recommended for a construction permit.” said Greg Piefer, CEO of
SHINE. “We’ve developed a greener, safer, and cheaper way to produce
these isotopes on a global scale. Specifically, these documents are the
conclusion of more than four years of hard work and deliberation by both
the NRC staff and SHINE. We are tremendously proud to have earned the
recommendation of one of the world’s most highly-respected regulators.
Safety and environmental responsibility are top priorities at SHINE and
this milestone with the NRC validates our dedication to those values.”
The three documents recommending approval of the SHINE Construction
Permit are the:
Evaluation Report, which documents the NRC staff’s technical
review and ensures the design of the SHINE facility includes adequate
margin of safety, provides for the prevention of accidents and meets
applicable regulatory requirements.
Environmental Impact Statement concludes the NRC’s environmental
review, which evaluated the potential environmental, societal and
economic impacts of the SHINE facility.
from the Advisory Committee on Reactor Safeguards (ACRS) to the NRC
Chairman. The ACRS is an independent advisory committee appointed
by the Commission and made up of experts with a wide variety of
Once built, SHINE’s manufacturing plant will fulfill more than a quarter
of the world’s need for the most commonly-used medical isotope in the
world, molybdenum-99. It will be located in Janesville, WI and employ
Molybdenum-99 (moly-99) is a radioisotope that decays into the
diagnostic imaging agent technetium-99m (tech-99m). Tech-99m is used in
more than 40 million medical imaging procedures each year, primarily in
stress tests to diagnose heart disease and bone scans to stage cancer.
Despite constituting approximately half of world demand for moly-99, the
U.S. does not produce any moly-99 domestically and imports 100 percent
of its supply from foreign nuclear reactors. The majority of these
reactors are beyond their original design life and scheduled to be shut
down in the coming years. Previous outages of these aging facilities
have caused major isotope shortages, significantly impacting patient
care. SHINE was founded to deploy a safe, cost-effective and
environmentally friendly technology to produce medical isotopes,
About SHINE Medical Technologies, Inc.
Founded in 2010, SHINE is a development-stage company working toward
becoming a manufacturer of radioisotopes for nuclear medicine. The SHINE
system uses a patented, proprietary manufacturing process that offers
major advantages over existing and proposed production technologies as
it does not require a nuclear reactor, uses less electricity, generates
less waste and is compatible with the nation’s existing supply chain for
molybdenum-99. In 2014, SHINE announced the execution of molybdenum-99
supply agreements with GE Healthcare and Lantheus Medical Imaging. Learn
more at http://shinemed.com.
SHINE Medical Technologies, Inc.
Katrina Pitas, (608) 210-1060
of Business Development