NorthStar Medical Radioisotopes announced the company received its fifth federal approval from the U.S. Food and Drug Administration (FDA) on Wednesday related to the production of isotopes used in thousands of medical imaging tests every day.

BELOIT — NorthStar Medical Radioisotopes marked another milestone on Wednesday as the company announced receiving a fifth federal approval for aspects of its production process of substances used in medical testing.

The U.S. Food and Drug Administration (FDA) approved NorthStar’s process for producing the medical radioisotope molybdenum-99 (Mo-99) from a concentrated isotope known as molybdenum-98 (Mo-98).

The company uses its patented RadioGenix system to generate the isotope technetium-99m (Tc-99m) that uses Mo-99 as its source material. Tc-99m is used in 40,000 patient imaging studies per day in the United States as standard of care to assess extent and severity of heart disease and cancer.

Wednesday’s news marks the first and only commercial-scale application of Mo-98 technology and will significantly increase domestic production and capacity of Mo-99 in the United States.

NorthStar President and CEO Stephen Merrick said the most recent FDA approval was a “transformational event” for the company, adding that it was a “key milestone in significantly increasing domestic production and capacity of non-uranium based Mo-99 for the United States.”

In February of 2018, NorthStar received its first FDA approval for aspects of its production process, paving the way for isotope production in partnership with the Missouri Research Reactor (MURR) in Columbia, Missouri. Since then, the company has growth rapidly in Beloit, both in terms of full-time staff to additional production space.

The company ended 2020 amidst rapid development at the 1800 Gateway Boulevard campus with the construction of a 34,700 square-foot expansion as part of an overall $40 million investment in the area. The project will accommodate two particle accelerators that will aid in the production of radioisotopes, along with an accompanying processing facility.

Work on NorthStar’s isotope processing facility is complete as equipment installation, testing and qualification remain on track, Merrick said. Upon further FDA approval, the isotope processing facility will augment current processing taking place at MURR, with an estimated completion by mid-2022.

Construction at the accelerator production facility remains on schedule and the two particle accelerators are undergoing final testing in Belgium prior to shipment to NorthStar.

“We expect the first pair of accelerators to be installed in early 2021 with FDA approval planned for late 2022/early 2023,” Merrick said.

Merrick said the company expects to grow its full-time employee base of around 230 staff further in 2021.

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