Jim Leute, The Janesville Gazette – used with permission

JANESVILLE, WI – December 6, 2014 There’s no shortage of companies that want to fill an impending gap in North American medical isotope production.

A Google search offers plenty of evidence, said Greg Piefer, founder and chairman of SHINE Medical Technologies, the company that starting in 2018 plans to make molybdenum-99 and other medical isotopes in Janesville.

“Everybody that has any idea on how to produce Mo-99 is coming out of the woodwork,”Piefer said. ”None of that keeps me awake at night.

“I was at that stage six years ago.”

The path from an idea to commercial production is tedious and expensive, he said.

SHINE is seeking Nuclear Regulatory Commission approval for its Janesville plant that would create 150 jobs in a business Piefer has estimated will generate $200 million in annual revenues.

The company is two years, $40 million and 70,000 pages of data into the federal review, which the company hopes will end with a construction permit and a groundbreaking in early 2016.

“We had two years just getting ready for the NRC, and we’ve got two years in with them,”Piefer said. “lf we can keep the beat, keep the pace, I feel very strongly about our position.

“Everyone wants to solve this problem. We were fortunate to be there early.”

The problem Piefer references is that nearly all Mo-99 is generated using weapons-useable highly enriched uranium at outdated facilities outside the United States.

That has led to product shortages and created safety and national security concerns.

The United States does not have production capability for Mo-99 and must import its supply from foreign producers, most of which use highly enriched uranium and rely on aging facilities that are increasingly prone to unexpected shutdowns.

The Mo-99 supply chain is expected to become significantly more fragile when Canadian medical isotope production ends in 2016, Piefer said.

Mo-99 is an isotope used in more than 30 kinds of diagnostic imaging procedures and more than 40 million medical imaging tests each year.

Ithas an incredibly short half-life, so North American production is crucial to serve the North American market, Piefer said.

When it opens in 2018, the Janesville plant is expected to produce more than a quarter of the world’s supply for Mo-99.

In 2012, Congress passed the American Medical Isotopes Production Act to improve the reliability of

U.S. medical isotope supply by supporting domestic projects that can produce Mo-99 without the use of highly enriched uranium.

The U.S. Department of Energy is supporting that goal with commitments of up to $25 million for each domestic company working to produce the isotopes without highly enriched uranium.

So far, SHINE has received more than $14 million under the program.

It plans to use low-enriched uranium in a series of eight accelerators to produce molybdenum-99 As required, it’s matched the federal money dollar-for-dollar.

Coincidentally, the two leading companies pursing domestic medical isotope production-SHINE and Northstar Medical Radioisotopes-both want Rock County as their base.

Northstar is building a facility in Beloit. Ithas received and matched more than $16 million from the federal program.

Piefer said fundraising, not competition, continues to be SHINE’s biggest challenge.

Including plant costs, the company is in the process of raising about $200 million from private and public sources. Company officials, however, have been reluctant to reveal how much of that has been raised because of the complexity, intricacies and variables tied to some of the deals.

As SHINE progresses with its plans and federal review, risks are mitigated that make private investments more attractive, Piefer said

Still, 2014 has been a successful year, he said.

In addition to the federal money, SHINE secured $7 million in private commitments, much of it from Wisconsin investors, some of whom are radiologists and pharmacists who will be the end-users of SHINE’s products, Piefer said.

In October, SHINE signed a $125 million debt and equity financing deal with a New York health care investment firm.

The company also signed distribution agreements with GE Healthcare and Lantheus Medical Imaging, two of the three distributors of medical isotopes in the United States.

Piefer said SHINE would pursue the third U.S. distributor, as well as distributors around the globe. Signing the first two, however, guarantees the company a break-even position, he said.

“It really seems that those in the know are supporting SHINE,” Piefer said. “We believe we’re in the right place at the right time to solve the problem with a clever new technology.”