NorthStar Medical Radioisotopes Announces FDA Approval of Beloit, Wis. Facility for RadioGenix™ System Manufacturing and Provides Update on Commercial Launch Status
– Approval enables expanded manufacturing capacity and supports commercial launch of RadioGenix Systems to produce critically important diagnostic imaging radioisotope technetium-99m from domestic, non-uranium based molybdenum-99 –
“NorthStar has quickly achieved several key milestones in advancing our strategically planned RadioGenix System roll-out,” said George P. Messina, Chairman and CEO of NorthStar. “First, the FDA approval of our Beloit manufacturing facility enables us to scale up production and expand capacity to meet anticipated customer demand. The approval came well in advance of the anticipated FDA action date. Second, we are also very pleased to announce that the commercial launch of the RadioGenix System has commenced, with the first contract signed and the first installation scheduled at a customer site. This important event marks another milestone in NorthStar’s commitment to provide the United States healthcare system with a reliable, domestic non-uranium based Mo-99 supply for production of the important medical diagnostic imaging radioisotope, technetium-99m. We anticipate shipping additional RadioGenix Systems as potential customers receive licensing amendments for their sites, and look forward to sharing our progress.” Read the full story here.