JANESVILLE, Wis., Oct. 15, 2019 – 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.”
About Medical Isotopes
Medical isotopes are radioisotopes that are used in the diagnosis and treatment of disease. Molybdenum-99 (Mo-99) is a radioisotope that decays into the diagnostic imaging agent technetium 99m (Tc-99m). The workhorse of nuclear medicine, Tc-99m is used in more than 40 million medical imaging procedures each year, primarily in stress tests to diagnose heart disease and to stage cases of cancer. SHINE was founded to deploy a safe, cost-effective and environmentally friendly technology to produce a variety of medical isotopes, including Mo‑99. Roughly one percent of all Mo-99 in the world decays every hour, meaning it must be produced continuously. Current production is limited to only a handful of government-owned nuclear research reactors, the majority of which are overseas.
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.