Shine Medical Technologies says it has received approval from a federal regulator to build a manufacturing facility where the company plans to produce a crucial medical isotope.
The Nuclear Regulatory Commission authorized the issuance of a construction permit to Shine Thursday, says Katrina Pitas, the company’s vice president of business development. The facility will be located in Janesville, WI, which is about 40 miles southeast of Shine’s headquarters in Madison, WI.
“We are thrilled today,” Pitas says. “We’re feeling good about moving onto the next phase.”
Shine plans to use the facility to make molybdenum-99, which in turn is used to produce technetium-99m, the most widely used radioisotope is medical diagnostic imaging. Molybdenum-99 is used in about 20 million procedures in the U.S. annually, according to a World Nuclear News report. The global market for the isotope is about $600 million per year, Shine founder and CEO Greg Piefer has previously told Xconomy.
Pitas says Shine expects to break ground on the 57,000-square-foot structure sometime next year, produce test batches of isotopes in 2018, and be in full commercial production by 2019.
But first, the company must obtain an operating license from the NRC. Pitas says it typically takes the regulator 18 to 24 months to review applications for operating licenses. Whereas the construction permitting process involves demonstrating that a proposed facility will be safe for people and the environment, applying for an operating license is more about the mechanics of running the plant, she says.
“There’s going to be a lot of discussion about operating procedures,” Pitas says. “How do we start up the machine? How do we turn it off? Under what conditions can we operate?”
While the operating license represents yet another hurdle Shine must clear, Pitas says the company was more worried about getting the construction permit, in part because some regulators were seeing Shine’s technology for the first time.
Shine’s new permit is the first authorization the NRC has issued for a “non-power utilization or production facility” since 1985, the regulator says in a press release. Molybdenum-99 hasn’t been produced domestically since 1989, according to the release.
During the years since, the U.S. has imported the isotope from Canada, as well as countries in the Eastern Hemisphere like Australia, South Africa, Belgium, and the Netherlands. Importing molybdenum-99 from across an ocean is expensive because the isotope’s 66-hour half-life mans about 1 percent of finished product is lost every hour.
Pitas says Shine currently has 25 employees but that by the time it’s operating fully in 2019, it expects its headcount will have grown to about 150. The company will need to hire operators to staff the facility round-the-clock, as well as “mechanically-minded people” to maintain equipment, she says.
Shine has raised nearly $50 million since launching in 2010. It has signed supply agreements with GE Healthcare and Lantheus Medical Imaging, two distributors of molybdenum-99.
