March 1, 2016 — Wisconsin-based Shine Medical Technologies Inc., producer of medical tracers and cancer treatment elements, announced that the U.S. Nuclear Regulatory Commission (NRC) has authorized issuance of the Shine construction permit. With the construction permit in hand, Shine has federal regulatory approval to begin construction of its approximately 57,000-square-foot medical isotope manufacturing facility in Janesville, Wis.
Shine is the only U.S. medical isotope producer to have reached this stage of the NRC permitting process since the 1960s.
The issuance of the construction permit is the culmination of more than four years of effort by both Shine and the NRC. It follows two years of environmental data collection and safety analysis by Shine, as well as two years of rigorous safety and environmental reviews by the NRC.
Shine’s work is supported by the Department of Energy’s National Nuclear Security Administration’s molybdenum-99 program, which seeks to develop reliable and sustainable domestic production of molybdenum-99 (moly-99) without the use of highly enriched uranium. 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 United States 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.
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 does not require a nuclear reactor, uses less electricity, generates less waste and is compatible with the nation’s existing supply chain for moly-99.
Shine is one of four commercial projects that the U.S. Department of Energy, National Nuclear Security Administration established partnerships with since 2010 to accelerate the establishment of a reliable U.S. domestic supply of molybdenum-99 produced without the use of highly enriched uranium.
In 2014, SHINE announced the execution of moly-99 supply agreements with GE Healthcare and Lantheus Medical Imaging. In 2015, with the help of Argonne National Laboratory, GE Healthcare demonstrated SHINE moly-99 can act as a drop-in replacement for reactor-based moly-99.
For more information: www.shinemed.com