SHINE Medical Technologies LLC today announced that the U.S. Nuclear Regulatory Commission (NRC) expects to make a final determination regarding the issuance of an operating license to SHINE by October 2021. SHINE’s application for a license to operate the medical isotope production facility that it is building in Janesville, Wis., was accepted and docketed by the NRC last October.
“The review schedule established by the NRC for our application reflects the quality of our submission, our effective engagement with NRC staff, and the diligence and hard work of the entire SHINE team,” said Greg Piefer, chief executive officer of SHINE. “The review schedule also reflects a very well prepared and engaged NRC staff. SHINE will continue to work with the NRC to advance the review of SHINE’s operating license application.”
SHINE’s application seeks the NRC’s approval to operate its transformational non-reactor technology at the Janesville plant. The facility will produce essential medical isotopes, including molybdenum-99, or Mo-99, which is used in more than 40 million medical patient procedures every year. The facility’s construction has continued during Wisconsin’s stay-at-home order under applicable health guidelines and is moving forward according to plan. SHINE expects the building to be weather-tight by the end of 2020 and producing Mo-99 at commercial scale by 2022.
“The completion of SHINE’s production facility is critical to patients in the United States,” Piefer said. “The supply chain that serves U.S. patients is almost entirely reliant on foreign suppliers. The restriction of isotope shipments from Europe during the current global health crisis reinforces the profound need for substantial, reliable domestic production of Mo-99.”
Once SHINE’s facility is complete, it will be capable of supplying two-thirds of the U.S. patient demand for Mo-99.
About SHINE Medical Technologies LLC
Founded in 2010, SHINE is a development-stage company working to become 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. It does not require a nuclear reactor, uses less electricity, generates less waste and is compatible with the nation’s existing supply chain for Mo-99. In 2014, SHINE announced the execution of Mo-99 supply agreements with GE Healthcare and Lantheus Medical Imaging. In 2015, with the help of Argonne National Laboratory, GE Healthcare demonstrated that SHINE Mo-99 can act as a drop-in replacement for reactor-based Mo-99. In 2016, SHINE received regulatory approval from the Nuclear Regulatory Commission to construct its production facility. The company began construction of the facility in the spring of 2019 and strong progress on it continues.