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.