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-footmedical isotopemanufacturing 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的工作得到了美国能源部国家核安全局钼-99项目的支持，该项目寻求在不使用高浓缩铀的情况下发展可靠和可持续的国内钼-99生产。钼-99 (moly-99)是一种放射性同位素，衰变为诊断显像剂锝-99m (tech-99m)。tech - 9900万每年被用于超过4000万次医学成像过程，主要是用于诊断心脏病的压力测试和用于分期癌症的骨骼扫描。
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 fornuclear 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项目是美国能源部和国家核安全管理局自2010年以来建立合作伙伴关系的四个商业项目之一，目的是加快在美国国内建立不使用高浓缩铀生产的钼99的可靠供应。
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
August 10, 2022
