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NorthStar Medical Radioisotopes, LLC announces business update and commercial progress on RadioGenix System

Press releases may be edited for formatting or style | February 05, 2019 Molecular Imaging

NorthStar is making important progress in achieving its vision to become a leading medical radioisotope production company:

RadioGenix System Commercial Progress

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NorthStar continues to successfully implement its carefully staged launch of the RadioGenix System.

· Commercial RadioGenix Systems are on the market, providing the medically important diagnostic radioisotope, technetium-99m (Tc-99m) from domestically produced, non-uranium based molybdenum-99 (Mo-99), with positive customer feedback.
· Numerous customer sites are in the licensure amendment process, with many further placements planned in 2019.
· Every week, a significant number of Tc-99m doses are being dispensed using RadioGenix Systems, with market uptake continuing to be strong and growing. Domestic, non-uranium based Mo-99 used in RadioGenix Systems helped alleviate the severe November, 2018 supply shortage precipitated by multiple overseas supplier outages.
· In recognition of FDA approval of the RadioGenix System and domestic Mo-99, NorthStar received an Award for Outstanding Achievement from the U.S. Department of Energy's National Nuclear Security Administration as the first producer of molybdenum-99 (Mo-99) in the United States in nearly 30 years.

Initiatives to Increase Mo-99 Manufacturing and Production Capacity

In its efforts to support increased Mo-99 production capacity, NorthStar is expanding its cGMP manufacturing capabilities and overall footprint in Beloit, Wis.

· The U.S. Food and Drug Administration (FDA) approved the Company's Beloit, Wis. facility for manufacture of RadioGenix Systems and associated components, marking a first step in NorthStar's efforts to expand Mo-99 production capacity to meet anticipated customer demand.
Construction is well underway on NorthStar's 20,000 square foot facility expansion in Beloit, which is planned to more than double its capacity to fill Mo-99 Source Vessels, once dissolution and filling equipment is installed, qualified, validated and then FDA approved.
NorthStar is nearing final validation of two state-of-the-art Source Vessel filling systems at its facility in Columbia, Mo. that, pending FDA approval, will immediately increase the number of Mo-99 Source Vessels available for shipment weekly.
NorthStar continues to expand organizationally, currently employing more than 160 highly trained professionals to advance its efforts.

Executive Team Alignment to Further Drive Commercial Growth

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