NorthStar Medical Radioisotopes Announces Construction Completion of Beloit, Wisconsin Processing Facility for Expanded Domestic Production of Medically Important Molybdenum-99 (Mo-99)

BELOIT, Wis.--(BUSINESS WIRE)-- NorthStar Medical Radioisotopes, LLC, a global innovator in the production and distribution of radioisotopes used for medical imaging, today announced completion of construction on its 20,000 square foot molybdenum-99 (Mo-99) processing facility in Beloit, Wis., with equipment installation currently underway. Establishing this processing facility is part of NorthStar’s staged development and dual processing pathway approach to expanding current capacity and efficiencies in Mo-99 production. Domestically produced, non-uranium based Mo-99 is used in NorthStar’s RadioGenix^® System (technetium 99m generator). Commercially available and FDA-approved, the RadioGenix System is an innovative, high tech separation platform for processing non-uranium/non-highly enriched uranium based Mo-99 for production of the important medical radioisotope, technetium-99m (Tc-99m), the most widely used diagnostic imaging radioisotope.

“Construction completion of our Beloit, Wis. Mo-99 processing facility is a significant marker of NorthStar’s progress, as we continue to execute on our plan to meet customer demand and ensure reliable, non-uranium based radioisotope supply for the United States. We are grateful to Corporate Contractors Incorporated (CCI), the lead contractor for this complex construction project, for ensuring that the building handover has occurred on schedule, and installation of equipment for the facility is underway,” said Stephen Merrick, President and Chief Executive Officer of NorthStar. “In conjunction with our partners at the University of Missouri Research Reactor (MURR^®), NorthStar is consistently providing domestic, non-uranium based Mo-99 now, and actively planning for the future. Upon appropriate licensure and FDA approval, this processing facility in Beloit will augment current processing at MURR, providing us with dual production hubs for Mo-99. The new facility will enable us to double production of RadioGenix System source vessels, which are used by radiopharmacies to produce Tc-99m for physicians and their patients.

“Our installed base of RadioGenix Systems continues to grow in line with plan. Importantly, the system is increasingly providing customers with Tc-99m for patients’ diagnostic imaging tests, on time and when they need them. During the eight months since becoming commercially available, RadioGenix Systems have provided continuous, undisrupted domestic Mo-99 supply to meet customer and patient needs for Tc-99m. In contrast, during the same time period, Mo-99 supply from the current supply chain, which is dependent on overseas nuclear reactors and processors, has been impacted by almost weekly disruptions, some being pronounced and lengthy.”

Mr. Merrick continued, “In addition to the processing facility expansion, we are working toward final validation of two state-of-the-art fill lines at our Columbia, Missouri facility that, pending expected FDA approval this year, will further substantially increase the number of Mo-99 source vessels that we are able to ship to customers weekly. Activities for accelerator production of Mo-99 are underway, with the initial accelerators ordered and groundbreaking for a 20,000 square foot accelerator facility in Beloit scheduled for later this year.”

NorthStar’s 20,000 square foot processing facility in Beloit, Wis. will house state-of-the-art Mo-99 dissolution and source vessel filling equipment, as well as support a quality control laboratory, an automated packaging line and an advanced molybdenum recycling complex. The facility will begin processing upon completion of appropriate licensure and FDA approval.

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.

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.
• 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 kits, 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 12 hour expiration time from elution is reached, whichever occurs earlier.

To report SUSPECTED ADVERSE REACTIONS, contact NorthStar Medical Radioisotopes, LLC at 1-844-438-6659; or FDA at 1-800-332-1088 or www.fda.gov/medwatch.

For Full RadioGenix^® System Prescribing Information, click here or visit https://www.northstarnm.com/wp-content/uploads/2018/04/PI_Rev04_23mar2018.pdf.

About NorthStar Medical Radioisotopes, LLC (NorthStar)
NorthStar Medical Radioisotopes is a nuclear medicine technology company committed to providing the United States with reliable and environmentally friendly radioisotope supply solutions to meet the needs of patients and to advance clinical research. The Company’s first product is the RadioGenix^® System, an innovative and flexible platform technology initially approved by the U.S. Food and Drug Administration in 2018 for the processing of non-uranium/non-highly enriched uranium based molybdenum-99 (Mo-99), the parent isotope of technetium-99m (Tc-99m), which is currently the most widely used diagnostic radioisotope for medical purposes. NorthStar’s proprietary and patented technologies include non-uranium based molybdenum-99 domestic production methods, patented separation chemistry systems, patented sterilization systems and a technology platform that potentially allows expanded product offerings to provide solutions in both the diagnostic and therapeutic markets. Founded in 2006 and based in Beloit, Wis., NorthStar Medical Radioisotopes, LLC is a wholly-owned subsidiary of NorthStar Medical Technologies, LLC. For more information, visit: www.northstarnm.com.

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