Mr. Merrick continued, “We continue to successfully deliver on our Mo-99 production plans and RadioGenix System enhancement roadmap, with this cMo-98 approval marking the fifth FDA approval for the RadioGenix System and non-uranium-based Mo-99 production since 2018. The RadioGenix System is changing the way that radiopharmacies plan for having reliable, domestic Mo-99 supply on time and when needed. We are pleased to note that NorthStar has now achieved two years of reliable commercial production. Our active expansion to ensure continued, reliable domestic Mo-99 supply through establishing dual production and processing hubs for additional capacity and scheduling flexibility remains on track. Equipment installation, testing and qualification is proceeding on schedule, and upon appropriate licensure and FDA approval, our Isotope Processing facility in Beloit, Wis., will augment current processing in Columbia, Mo. Our Accelerator Production facility construction in Beloit, which will enable additional production of Mo-99 using “neutron knock-out” technology continues on track, with the initial pair of accelerators undergoing final testing prior to shipment to the United States, where we expect them to be installed in early 2021.”

“NorthStar is the first company to deploy innovative cMo-98 technology for radioisotope production on a commercial scale,” said James T. Harvey, PhD, Senior Vice President and Chief Science Officer of NorthStar. “The process uses natural molybdenum, which is approximately 24% Mo-98, that has been concentrated to be up to 98% Mo-98 (cMo-98), to produce Mo-99 using neutron capture technology.”

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 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 based Mo-99, designed to help alleviate shortage situations and expand domestic supply.


About NorthStar Medical Radioisotopes, LLC (NorthStar)
NorthStar Medical Radioisotopes is a commercial-stage nuclear medicine company that develops, produces and manufactures reliable and environmentally-friendly diagnostic and therapeutic radiopharmaceuticals. Its first FDA-approved diagnostic imaging product is technetium-99m (Tc-99m), which 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. Tc-99m is generated by NorthStar’s novel RadioGenix ® System (technetium Tc-99m generator) which uses U.S.-produced, non-uranium based molybdenum-99 (Mo-99) as its source material. The Company is executing a well-defined plan to consistently increase the scale of Mo-99 production and to continuously improve efficiencies to meet anticipated increased demand. Therapeutic radioisotopes are increasingly important cancer treatment options, and NorthStar is developing commercial-scale production technologies to meet high demand for their use in ongoing clinical trials by multiple pharmaceutical companies. In addition, the Company is advancing a portfolio of other radiopharmaceuticals for use in therapeutic and diagnostic applications.

Back to HCB News

Molecular Imaging Homepage