nuclear-news

February 08, 2018   BELOIT, Wis.–(BUSINESS WIRE)--NorthStar Medical Radioisotopes, LLC, (NorthStar) a company involved 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 RadioGenix^TM System, an innovative, high tech radioisotope separation platform indicated for use in producing the widely used medical radioisotope technetium-99 (Tc-99m) from NorthStar’s non-uranium based molybdenum-99 (Mo-99). The RadioGenix^TM System is indicated as “a technetium Tc 99m generator used to produce sterile, non-pyrogenic Sodium Pertechnate Tc 99m Injection.”There has been no U.S. production of Mo-99, the parent isotope of Tc-99m, for more than 25 years. The supply of Mo-99 has been subject to frequent and sometimes prolonged interruptions, disrupting and often delaying the diagnosis and treatment of patients in need of medically important diagnostic tests that require the use of this radioisotope. Furthermore, current bulk production of Mo-99 is based on enriched uranium which poses significant environmental concerns.“With the FDA’s approval of the RadioGenix System, NorthStar can begin providing its customers with a reliable and environmentally friendly supply of the Mo-99 radioisotope for the United States,” said George P. Messina, Chairman and CEO of NorthStar Medical Radioisotopes. “As the first, and thus far only company to achieve the objective of being the first U.S. producer of Mo-99 in more than 25 years, we are extremely proud to pioneer domestic production of Mo-99 that is independent of uranium-based product. The approval by the FDA will reduce the U.S. healthcare system’s reliance on fragile foreign supply of Mo-99 and the use of enriched uranium target material.  The RadioGenix System allows for automated, on-site separation and preparation of U.S. Pharmacopeia (USP) Sodium Pertechnetate Tc 99m Injection from Mo-99. The RadioGenix is also a platform technology that has the potential ability to apply its separation capabilities at the point-of-care to other radioisotopes in the future, including therapeutic isotopes such as actinium-225/bismuth-213 (which will require FDA approval). ……….

The RadioGenix System is an innovative, high tech system 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 February 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. ………..   https://www.businesswire.com/news/home/20180208005961/en/U.S.-FDA-Approves-NorthStar-Medical-Radioisotopes%E2%80%99-RadioGenixTM#.Wnzqgpg9SWY.facebook