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.
“This is the first time in over fifty years a medical isotope plant has been recommended for a construction permit.”
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:
- Safety 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.
- Final Environmental Impact Statement concludes the NRC’s environmental review, which evaluated the potential environmental, societal and economic impacts of the SHINE facility.
- Letter 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 nuclear expertise.
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 150 people.
About Moly-99
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, including moly-99.
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.
Contacts
SHINE Medical Technologies, Inc.
Katrina Pitas, (608) 210-1060
VP of Business Development
katrina.pitas@shinemed.com
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