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.”
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.
Based in Janesville, Wisconsin, SHINE deploys its safe, cost-effective and environmentally friendly fusion technology in a stepwise approach. Its systems are used to inspect industrial components in aerospace, defense, energy and other sectors. SHINE’s proprietary medical isotope production processes create non-carrier-added lutetium-177 and are expected to create molybdenum-99. In the future, SHINE plans to scale its fusion technology to help solve one of energy’s toughest hurdles by recycling nuclear waste. Through a purpose-driven and phased approach, SHINE aims to generate fusion power to deliver clean, abundant energy that could transform life on Earth. Want to learn more about SHINE? Follow us on social media @shinefusion and sign up for our email newsletter to follow us on our journey!
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