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(Janesville, WI) Neil Johnson, Gazette

After four years of development, regulatory screening and a complex approval process for a proposed radioactive medical isotope production facility in Janesville, SHINE Medical Technologies has received the clearance it's been waiting for.

Thursday morning, the federal Nuclear Regulatory Commission voted to approve SHINE's request for a construction permit to build a 57,000-square-foot radioisotope facility at 4021 S. Highway 51 across from the Southern Wisconsin Regional Airport on Janesville's south side.

The federal panel has spent the last two years vetting the proposed project for safety and environmental impacts.

The review essentially gives SHINE the go-ahead to construct the facility, which will use nuclear particle accelerators to produce the radioactive medical isotope molybdenum 99 from low-enriched uranium.

The Nuclear Regulatory Commission still must complete a separate, lesser phase of regulatory review for SHINE's operating permit, but under the panel's decision Thursday, SHINE has the clear to move into construction and commercialization phases of the project.

SHINE is on track to break ground on the project in 2017, and the company will begin ramping up operations in 2018. That puts SHINE on pace to begin shipping moly-99 in early 2019, SHINE Vice President Katrina Pitas said Thursday.

“We're shooting for that goal and working as hard as we can to get there,” Pitas said.

The facility in Janesville is slated as one of three or four radioisotope production facilities that could operate in the U.S. within a couple of years, Pitas said.

Molybdenum-99 is a radioisotope used to illuminate heart, bone and other body tissue in 40 million medical imaging procedures a year. It is mainly used in heart disease screening, stress tests and for bone scans used to locate and diagnose cancer.

SHINE would operate the first U.S. moly-99 production facility in the nation since the 1960s.

Another medical radioisotope company, NorthStar Medical Radioisotopes, is operating in Beloit, but NorthStar does not yet produce moly-99 on site. 

SHINE would produce moly-99 on site, then ship the isotope to suppliers, which would distribute to Midwest specialty pharmacies. The company also would supply markets abroad, Pitas has said.

SHINE has major supply agreements with GE Healthcare and Lantheus Medical Imaging.

It would be the first entirely private outlet through which Moly-99 would be produced, distributed and shipped to hospitals and medical testing laboratories, SHINE officials say.

Pitas on Thursday said a mix of SHINE employees and a handful of initial investors—about 40 people--watched a remote, live stream of the nuclear panel's meeting Thursday on TVs throughout the company's Monona headquarters.

She said as the news came, SHINE's headquarters broke into cheers. Engineers, company executives and investors embraced.

As Pitas took photographs of the moment, she said her eyes brimmed with tears. And she wasn't the only SHINE employee who cried in joy.

“It was exhilarating. It's what we've been waiting for. We've dedicated years of our lives to this,” Pitas said.

The company has developed a special set of particle accelerators that it has spent nearly half a decade testing in partnership with federal nuclear programs.  

Pitas has said that in recent months, the Nuclear Regulatory Commission had “raced” through latter stages of a review process, following a weeks of page-by-page review of tens of thousands of pages of SHINE's plan documents and related report. Review included months of public comment, research by the panel's staff and an independent review by a team of federal cross-checkers.

Because the facility will rely on nuclear particle acceleration, the federal panel had required SHINE to conduct intensive calculations and hypothetical modeling to prove that its plans met federal thresholds for safety and environmental impact. 

Among the research, SHINE was required to calculate the potential risk and impact to SHINE's Janesville facility if tsunami-like waves ever formed on Lake Michigan or Lake Superior—and then rushed over the Wisconsin landmass, covering Janesville with water.

Belying the intensity of regulatory review, federal authorities and the U.S. Department of Energy have been supportive of the idea of SHINE's project and a few other medical radioisotope production facility plans, mainly because of the specter of a world shortage of moly-99.

The U.S. is responsible for about half the world's demand for moly-99, yet none of the radioisotope is produced here. All of the material is imported from government-owned nuclear reactors in Canada, Europe and Africa.

Most of those foreign reactors are aging and are slated to be shut down within a few years. That would lead to a shortage of moly-99 not just in the U.S., but worldwide.

SHINE continues to raise money to construct and commercialize the Janesville facility.

As of this week, Pitas said, the company has raised approximately $50 million, including $22 million in private funding, through two waves of fundraising and a $15 million U.S. Department of Energy cost-share agreement.

Earlier estimates of the project's cost totaled $85 million, but Pitas has more recently declined to discuss specifics about the project's full costs.

SHINE's timeline for breaking ground and ramping up production at its Janesville facility has shifted a few times from an initial estimate that it would be producing and shipping moly-99 commercially in Janesville by 2017.

The delay came as SHINE's project plans remained under regulatory review.

Pitas said that between financing that SHINE has in hand, its supplier partnerships, and the federal government nod to the project on Thursday, SHINE is “well-positioned to finance the upcoming commercialization phase,” Pitas said.

On Thursday, Pitas said there's “nothing tentative” about SHINE's plan to have a facility built and producing on a commercial level by early 2019.

SHINE plans a private “celebration event” Thursday, March 10, in Janesville.

The city of Janesville has a stake in the SHINE plan. Years prior to the project getting full regulatory approval, the city council approved a tax increment financing incentive package worth $9 million, including utilities, land and cash and an agreement to back a private loan to SHINE.

The only city TIF agreement larger than SHINE's was an incentive package of $11.5 million, which the city awarded last year to Dollar General, which plans to build a 1 million-square-foot distribution center on Janesville's south side.

The city's incentive package for SHINE is tied to the company meeting criteria of property tax payments and job creation in Janesville.

SHINE has said it eventually would employ 150 at the Janesville facility, including technicians and mechanics. Many of the positions would pay annual salaries at or near $60,000, Pitas has indicated.

Pitas indicated SHINE plans to working on partnerships with at least one area technical college to launch training programs for radioactive material handling.

Pitas said that during the facility's expected life, SHINE will produce enough moly-99 for tests for 1 billion patients.    

“Today is a day when everybody in the community and the whole state of Wisconsin should be proud of what we've achieved … coming to market and producing the isotopes they need to stay healthy,” Pitas said.

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