Shine working toward U.S. production of Mo-99 for SPECT nuclear imaging
Shine Technologies is moving closer to restoring domestic production of molybdenum-99 (Mo-99), the most widely used isotope in nuclear medicine, after decades of reliance on foreign reactors. The company hopes to get its isotope production reactor online in the next couple years.
The Wisconsin-based company is building what it says will be the world’s largest dedicated medical isotope production facility, called the Chrysalis, in Janesville. When complete, the facility is expected to produce roughly 20 million patient doses of Mo-99 annually—enough to meet nearly half of the world’s demand.
Mo-99 is used to produce technetium-99m, which powers more than 80% of radiotracers for SPECT imaging, including the majority of nuclear cardiology perfusion scans.
“Right now, all commercial supply comes from aging reactors overseas. Our goal is to finally secure a domestic, reliable and scalable source," explained Greg Piefer, PhD, CEO and founder of Shine in an interview with Cardiovascular Business. "We are moving equipment in now, so probably 95 plus percent of all the equipment needed for Chrysalis is here in Janesville and we're starting to install it."
The U.S. has not had a continuous commercial Mo-99 production source since the 1980s. NorthStar commercially produced Mo-99 in the U.S. from its FDA clearance in 2018 to October 2023, but ended production because of competition from subsidized European reactors.
The U.S. largely relied on Canada’s Chalk River reactor until about 2016 when the 60 year-old reactor was shut down in 2016. For the past decade, the U.S. isotope supply has relied on European produced Mo-99 that is shipped using commercial airline flights. Shortages and supply disruptions have plagued hospitals ever since, forcing reliance on a handful of European and South African facilities. Compounding the challenge, Mo-99 has a 66-hour half-life, meaning U.S. patients lose up to a third of the isotope’s potency in shipping time from overseas.
By producing Mo-99 domestically and flying it directly from Janesville to radiopharmaceutical manufacturers, Shine expects to reduce decay losses dramatically.
“We should be able to get shipments to our processing partners in two hours instead of 30,” Piefer said. Unlike traditional nuclear reactors, The Chrysalis uses a fusion-driven process as its neutron source. The facility employs recyclable liquid low-enriched uranium targets to generate Mo-99 with far less nuclear waste and no reliance on weapons-grade uranium. The price for building and operating the new type of reactor is also a fraction of the costs for conventional nuclear reactors.
“At the end of the day, our cost to build this versus a new fission reactor is maybe 15%,” Piefer noted.
Shine has secured $32 million in federal funding from the National Nuclear Security Administration to advance its Mo-99 production, part of a long-running U.S. effort to eliminate dependence on foreign, highly enriched uranium for medical isotope supply.
The company has also strengthened its downstream distribution by acquiring the SPECT radioisotope division of Lantheus, a long-standing U.S. leader in SPECT imaging tracers.
“By combining our technology and investment with their established supply chain, we’ve ensured an efficient pathway from production to patients,” Piefer said.
Currently about 80% complete, the Chrysalis is expected to begin initial Mo-99 production within the next two years, with reliable commercial output anticipated in the two-to-three-year range. Shine also plans to replicate the model of the reactor in Veendam, the Netherlands, which currently is a primary supplier of Mo-99 to the U.S. He said Shine will also be able to support global supply.
“This is the hardest-working isotope in nuclear medicine,” he said. “By bringing Mo-99 production home, we can stabilize the supply chain for millions of patients and ensure the U.S. has control over one of the most critical resources in diagnostic imaging.”
Dave Fornell has covered healthcare for more than 17 years, with a focus in cardiology and radiology. Fornell is a 5-time winner of a Jesse H. Neal Award, the most prestigious editorial honors in the field of specialized journalism. The wins included best technical content, best use of social media and best COVID-19 coverage. Fornell was also a three-time Neal finalist for best range of work by a single author. He produces more than 100 editorial videos each year, most of them interviews with key opinion leaders in medicine. He also writes technical articles, covers key trends, conducts video hospital site visits, and is very involved with social media. E-mail: [email protected]