NorthStar Medical Radioisotopes, LLC, a global innovator in the production and distribution of radioisotopes used for medical imaging, today announced that the U.S. Food and Drug Administration (FDA) has approved the addition of two molybdenum-99 (Mo-99) filling lines at its facility in Columbia, Mo. Addition of the filling lines is part of NorthStar’s ongoing expansion plans to increase production and capacity of domestic, non-uranium based Mo-99 for the U.S. healthcare system. Mo-99 is a medical radioisotope used to produce technetium-99m (Tc-99m), the most widely used diagnostic imaging radioisotope and of critical importance for patient healthcare. FDA approval of the filling lines was made through expedited review of a Prior Approval Supplement to the original RadioGenix ® System (technetium Tc 99m generator) New Drug Application, which was approved in 2018. The RadioGenix System is an innovative, high tech radioisotope separation platform for use in producing Tc-99m from non-uranium based Mo-99. Since commercial availability nearly 16 months ago, RadioGenix ® Systems have provided customers with reliable Tc-99m supply for tens of thousands of patients’ diagnostic imaging studies, despite ongoing shortages from suppliers using legacy, uranium-based production methods.

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NorthStar produces non-uranium based Mo-99 in collaboration with its manufacturing partner, the University of Missouri Research Reactor (MURR ® ), in Columbia, Mo., using neutron capture technology. Natural Mo-98 is converted to Mo-99 at the MURR reactor and then processed into a radioactive Mo-99 solution. Filling lines at NorthStar’s facility on the MURR campus transfer the Mo-99 solution into tungsten-shielded containers called source vessels which are then shipped to radiopharmacies that have a RadioGenix System for use in producing Tc-99m used in combination with radiopharmaceutical kits and then injected into patients for diagnostic imaging studies.

“FDA’s expedited review and approval of the additional filling lines in our Columbia, Mo. facility means an immediate increase in Mo-99 production efficiencies in Columbia,” said Stephen Merrick, President and Chief Executive Officer of NorthStar. “This is one component of our efforts to increase dependable, domestically produced radioisotope supply for the United States. We particularly wish to express appreciation to our manufacturing partner, MURR. We look forward to continuing to work with MURR in progressing production efforts for concentrated Mo-98 (cMo-98), which, pending licensures and approval, will dramatically increase Mo-99 production capacity and our ability to provide larger-sized source vessels for our customers. We also want to thank Von Gahlen, who designed, built and installed these state-of-the-art filling lines.”

Mr. Merrick continued, “The expansion activities in Columbia run in parallel with NorthStar’s ongoing expansions in Beloit, Wis., where our Isotope Processing facility is nearing completion, and will augment processing at MURR. When approved, we will then have dual Mo-99 production hubs in Wisconsin and Missouri. In addition, construction of our Accelerator Production facility is underway, with the initial pair of electron beam accelerators being assembled in Belgium. We believe that all these efforts will further secure reliable, non-uranium based Mo-99 radioisotope supply for U.S. customers and patients.”



About the RadioGenix ® System (Technetium Tc 99m Generator) The RadioGenix System is an innovative, high tech separation platform that is approved for processing non-uranium/non-highly enriched uranium molybdenum-99 (Mo-99) for the production of the important medical radioisotope, technetium-99m (Tc-99m). Prior to availability of RadioGenix technology, the U.S. supply chain for Mo-99 has been subject to frequent and sometimes severe interruptions which negatively impact patient healthcare. Approved by the U.S. Food and Drug Administration in 2018, the RadioGenix System is the first and only on-site, automated isotope separation system of its kind for use with non-uranium/non-highly enriched uranium based Mo-99, designed to help alleviate shortage situations and expand domestic supply.

Indication and Important Risk Information about the RadioGenix ® System and Sodium Pertechnetate Tc 99m Injection USP

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INDICATION The RadioGenix ® System is a technetium Tc-99m generator used to produce Sodium Pertechnetate Tc 99m Injection, USP. Sodium Pertechnetate Tc 99m Injection is a radioactive diagnostic agent and can be used in the preparation of FDA-approved diagnostic radiopharmaceuticals.

To report SUSPECTED ADVERSE REACTIONS, contact NorthStar ® Medical Radioisotopes, LLC at 1-844-438-6659; or FDA at 1-800-332-1088 or www.fda.gov/medwatch. For Full RadioGenix ® System Prescribing Information, click here or visithttps://www.northstarnm.com/wp-content/uploads/2019/08/radiogenix-system-pi-july2019.pdf.

About NorthStar Medical Radioisotopes, LLC (NorthStar) NorthStar Medical Radioisotopes is a nuclear medicine technology company committed to providing the United States with reliable and environmentally friendly radioisotope supply solutions to meet the needs of patients and to advance clinical research. The Company’s first product is the RadioGenix ® System (technetium 99m generator), an innovative and flexible platform technology initially approved by the U.S. Food and Drug Administration in February 2018 for the processing of non-uranium/non-highly enriched uranium based molybdenum-99 (Mo-99), the parent isotope of technetium-99m (Tc-99m), which is currently the most widely used diagnostic radioisotope for medical purposes. NorthStar’s proprietary and patented technologies include non-uranium based molybdenum-99 domestic production methods, patented separation chemistry systems, patented sterilization systems and a technology platform that potentially allows expanded product offerings to provide solutions in both the diagnostic and therapeutic markets. Founded in 2006 and based in Beloit, Wis., NorthStar Medical Radioisotopes, LLC is a wholly-owned subsidiary of NorthStar Medical Technologies, LLC. For more information, visit: www.northstarnm.com.

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