BELOIT, Wis. – July 23, 2019 – NorthStar Medical Radioisotopes, LLC, a global innovator in the production and distribution of radioisotopes used for medical imaging, today announced that it has been awarded $15 million in a cooperative agreement with the U.S. Department of Energy’s National Nuclear Security Administration (DOE/NNSA) as part of an industry outreach initiative to establish reliable domestic molybdenum-99 (Mo-99) production without the use of highly enriched uranium. NorthStar will use funds from the award to further advance its current neutron capture technology which enables non-uranium based production of the important medical radioisotope Mo-99. Funds will also be used in continuing development of enhancements for the FDA-approved and commercially available RadioGenix System (technetium 99m generator). The RadioGenix System uses reliable, domestic, non-uranium based Mo-99 to supply physicians and their patients with the most widely used diagnostic imaging radioisotope, technetium 99m (Tc 99m).
“We greatly appreciate this new cooperative agreement award and the continued financial and technical support provided by DOE/NNSA, which will help NorthStar expand Mo-99 production capacity and efficiency, as well as support enhancements to the RadioGenix System to continue optimizing utility in radiopharmacies,” said Stephen Merrick, President and Chief Executive Officer of NorthStar. “Like DOE/NNSA, NorthStar shares a vision of protecting national security and the environment while providing the nuclear medicine community and the patients it serves with a reliable domestic supply of Mo-99 produced without highly enriched uranium.”
Mr. Merrick continued, “In conjunction with the RadioGenix System being increasingly used commercially, NorthStar is already producing domestic, non-uranium based Mo-99 and we are actively executing on our plans to expand our capacity to meet future needs. Construction is complete on our 20,000 square foot facility expansion in Beloit, Wis., which we believe will more than double production capacity for Mo-99 Source Vessels upon equipment installation and FDA approval. Additionally, pending expected FDA approval this year, two state-of-the-art fill lines at our Columbia, Mo. facility will increase the number of weekly Mo-99 Source Vessel shipments we are able to deliver to customers. Finally, I want to recognize the tremendous job our partners at the University of Missouri Research Reactor (MURR®) have done to help ensure that Mo-99/Tc-99m is available for radiopharmacies, healthcare providers, and, most importantly, patients.”
DOE/NNSA supports the establishment of a reliable domestic supply of Mo-99 produced in the United States without the use of highly enriched uranium (HEU), and with support from Congress, is providing $15 million for each of four cooperative agreements awarded under a recent Funding Opportunity Announcement. As with all DOE/NNSA cooperative agreements for domestic Mo-99 partners, DOE/NNSA matches NorthStar funding dollar for dollar, with the current agreement capped at a $30 million total in funds from both parties. NorthStar was selected by DOE/NNSA based on the evaluations and recommendations of an independent technical review panel. With inclusion of the current and past awards, NorthStar has been awarded a total of $65 million in cooperative agreements by DOE/NNSA.
“NorthStar’s enriched Mo-98 neutron capture program is one facet of our multi-pronged approach to increase domestic Mo-99 production capacity across multiple processing platforms, and we anticipate that the program will enable at least a four-fold increase in our Mo-99 production capability, pending appropriate licensures and regulatory approval,” said James T. Harvey, PhD, Senior Vice President and Chief Science Officer at NorthStar. “Enriched Mo-98 is produced by increasing the concentration of the Mo-98 isotope in natural molybdenum to more than 95% Mo-98. Then, using neutron capture technology, the enriched Mo-98 is converted to the medically useful radioisotope, Mo-99. Like other NorthStar Mo-99 processes, our Mo-98 neutron capture methodologies are non-uranium based.”
Established by Congress in 2000, NNSA is a semi-autonomous agency within the U.S. Department of Energy responsible for enhancing national security through the military application of nuclear science. NNSA maintains and enhances the safety, security, and effectiveness of the U.S. nuclear weapons stockpile without nuclear explosive testing; works to reduce the global danger from weapons of mass destruction; provides the U.S. Navy with safe and effective nuclear propulsion; and responds to nuclear and radiological emergencies in the U.S. and abroad. Visit energy.gov/nnsa for more information.
About the RadioGenix® System
The RadioGenix System is an innovative, high tech separation platform that is approved for processing non-uranium/non-highly enriched uranium based 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
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.
Sodium Pertechnetate Tc 99m Injection is also indicated in
· Adults for Salivary Gland Imaging and Nasolacrimal Drainage System Imaging (dacryoscintigraphy).
· Adults and pediatric patients for Thyroid Imaging and Vesicoureteral Imaging (direct isotopic cystography) for detection of vesicoureteral reflux.