SHINE Medical Technologies LLC today announced that the U.S. Nuclear Regulatory Commission (NRC) has accepted SHINE’s Operating License Application to operate its medical isotope production facility in Janesville, Wis. The NRC’s acceptance confirms that SHINE’s application was complete and of sufficient quality for the NRC to start its detailed technical review of the application. The next step involves the NRC conducting a regulatory audit to determine a detailed schedule for the remainder of the review.
SHINE’s application seeks regulatory approval to operate its transformational non-reactor technology that will produce essential medical isotopes, including molybdenum-99, or Mo-99, which is used in more than 40 million medical procedures every year. The facility will be capable of supplying two-thirds of the U.S. patient demand for the isotope. SHINE broke ground on construction in May.
“The NRC’s review of our operating license application is another step forward for SHINE’s effort to commercialize the Mo-99 isotope through our first-of-its-kind medical isotope production facility,” said Greg Piefer, SHINE’s founder and CEO. “We have made great strides since receiving our construction permit from the NRC and our team is now focused on constructing our facility to establish a reliable, global supply of Mo-99.”
Ongoing excavation at the site of the facility began in September. The next step in the construction process, concrete work, is expected to begin in October. SHINE expects to begin production of Mo-99 in 2021, with commercial production starting in 2022.
“We look forward to working with NRC staff as they conduct their review of the SHINE’s application,” said Jim Costedio, SHINE’s vice president of regulatory affairs and quality. “The development of our operating license application was a strong process that reflected great work by a comprehensive team that logged more than 150,000 person-hours of work. The application’s approval will be among the last steps in SHINE’s efforts to ensure that physicians and patients around the world have access to the isotopes they need.”