On May 11, 2021 NorthStar Medical Radioisotopes, LLC, a global innovator in the development, production and commercialization of radiopharmaceuticals used for medical imaging and therapeutic applications, reported that it has achieved a major milestone in its efforts to expand U.S. production capacity for the important medical radioisotope, molybdenum-99 (Mo-99) (Press release, NorthStar Medical Radiostopes, MAY 11, 2021, View Source [SID1234579710]). The Company has received two custom-built IBA RhodotronTT 300-HE (High Energy) electron beam accelerators at its facility in Beloit, Wisconsin. The accelerators are critical components in a first-of-its-kind commercial-scale process to produce Mo-99, the parent radioisotope of technetium-99m, the most widely used medical imaging radioisotope, informing healthcare decisions for approximately 40,000 U.S. patients daily.
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NorthStar Medical Radioisotopes is the sole commercial U.S. producer of the important medical radioisotope Mo-99 and the only company in the world to use environmentally friendly Mo-99 production processes that are non-uranium based. For over two years, NorthStar has provided the United States with reliable Mo-99 supply, which is used in its RadioGenix System (technetium Tc 99m generator) to produce Tc-99m. NorthStar is aggressively expanding and establishing dual production and processing hubs for additional Mo-99 capacity to better meet customer demand and to ensure reliable, sustainable U.S. supply. Two facility expansion projects are nearing completion in Beloit, Wisconsin, to augment current Mo-99 production and processing in Columbia, Missouri, conducted in partnership with the University of Missouri Research Reactor (MURR). NorthStar’s Isotope Processing facility in Beloit will enable it to more than double its current Mo-99 processing and is nearing completion, with FDA approval anticipated in 2022. The Company’s Accelerator Production facility in Beloit will add significant Mo-99 capacity, enable flexible production scheduling and minimize customer supply risks.
"Delivery of these electron beam accelerators to advance Mo-99 production marks a tremendous milestone event for NorthStar, nuclear medicine and the patients who rely on diagnostic imaging studies for their health," said Stephen Merrick, President and Chief Executive Officer of NorthStar Medical Radioisotopes. "Using electron beam accelerators is one of the most efficient methods of producing Mo-99, and like other NorthStar processes, it is non-uranium based and environmentally friendly. This production method will increase capacity, provide additional production days, and minimize supply risks. Additionally, electron beam accelerators can be used to produce therapeutic radioisotopes such as actinium-225 and copper-67. We anticipate that testing of these accelerators will begin this year, with commercial accelerator production commencing in 2023, pending appropriate licensure and FDA approval."
Mr. Merrick continued, "We are extremely grateful to all our partners and stakeholders for their support in achieving this milestone: the U.S. Department of Energy’s National Nuclear Security Administration and National Laboratories, the U.S. Food and Drug Administration, the Wisconsin Department of Health Services, our private commercial investors, NorthStar’s dedicated and talented employees, our supply chain partners, and our customers. We would like to recognize the support that our partners at the University of Missouri Research Reactor (MURR), with whom we jointly produce Mo-99 in Columbia, Missouri, continue to provide to NorthStar."
Mr. Merrick also added, "IBA (Ion Beam Applications S.A., EURONEXT), a leading global supplier of accelerators that is focused on bringing integrated and innovative solutions for the diagnosis and treatment of cancer, continues to be a tremendous collaborator in this effort, and we look forward to additional projects with them in the United States and globally. We are also proud to help showcase Wisconsin as a pioneer and leader in technology innovation and sustainable radioisotope production. Our expansion activities are supported by Corporate Contractors Incorporated (CCI), the lead contractor, Springs ATG (Advanced Technology Group) and Von Gahlen, a leading global supplier of state-of-the-art shielding solutions for nuclear medicine and radiopharmacy."
"This is a very exciting time for NorthStar and those involved in nuclear medicine. We all share a vision to accelerate the future of patient health by providing innovative solutions to ensure reliable access to radioisotopes that can make a positive difference in healthcare for people around the world," he concluded.
In conjunction with the delivery, NorthStar hosted, "From Belgium to Beloit, Wisconsin" on April 20, 2021, an event recognizing the significance of the occasion. Speakers included Stephen Merrick, President and Chief Executive Officer, and James Harvey, Senior Vice President and Chief Science Officer, as well as Diane Hendricks, Chairperson of the NorthStar Board of Managers. They highlighted NorthStar’s progress in delivering innovative technology to better patient health, its future plans, the increasingly important role of accelerators in radioisotope production and the Company’s commitment to nuclear medicine. The presenters showcased the state of Wisconsin as a pioneering leader in technology innovation and sustainable radioisotope production. In addition to expressing appreciation to NorthStar’s government and corporate partners, local contractors for the Accelerator Production facility were also recognized.
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 (FDA) 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.
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.
IMPORTANT RISK INFORMATION
Allergic reactions (skin rash, hives, or itching) including anaphylaxis have been reported following the administration of Sodium Pertechnetate Tc 99m Injection. Monitor all patients for hypersensitivity reactions.
Sodium Pertechnetate Tc 99m Injection contributes to a patient’s long-term cumulative radiation exposure. Ensure safe handling to protect patients and health care workers from unintentional radiation exposure. Use the lowest dose of Sodium Pertechnetate Tc 99m Injection necessary for imaging and ensure safe handling and preparation to protect the patient and health care worker from unintentional radiation exposure. Encourage patients to drink fluids and void as frequently as possible after intravenous or intravesicular administration. Advise patients to blow their nose and wash their eyes with water after ophthalmic administration.
Radiation risks associated with the use of Sodium Pertechnetate Tc 99m Injection are greater in children than in adults and, in general, the younger the child, the greater the risk owing to greater absorbed radiation doses and longer life expectancy. These greater risks should be taken firmly into account in all benefit-risk assessments involving children. Long-term cumulative radiation exposure may be associated with an increased risk of cancer.
Temporarily discontinue breastfeeding. A lactating woman should pump and discard breastmilk for 12 to 24 hours after Sodium Pertechnetate Tc 99m Injection administration.
Sodium Pertechnetate Tc 99m Injection should be given to pregnant women only if the expected benefits to be gained clearly outweigh the potential hazards.
Only use potassium molybdate Mo-99, processing reagents, saline and other supplies, including kit/packs, provided by NorthStar Medical Radioisotopes. Do not administer Sodium Pertechnetate Tc 99m Injection after the 0.15 microCi of Mo-99/mCi of Tc-99m limit has been reached or when the 24 hour expiration time from elution is reached, whichever occurs earlier. Follow step-by-step instructions for use provided in the Operator’s Guide, RadioGenix System 1.2.