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October 15th, 2019   /   Press Releases

Representatives from the U.S. Department of Energy’s National Nuclear Security Administration, State of Wisconsin, Medical Societies and Customers Join NorthStar Medical Radioisotopes’ Groundbreaking and Speaker Event


– Marking NorthStar expansion progress to increase U.S. production of non-highly enriched uranium produced molybdenum-99 (Mo-99), used in producing important medical isotope technetium-99m (Tc-99m) ‒

‒ Recognizing RadioGenix® System contributions in addressing ongoing Mo-99 supply shortages by providing customers with nearly a year of continuous medical radioisotope supply since launch ‒

Beloit, Wis., October 14, 2019 – NorthStar Medical Radioisotopes, LLC, a global innovator in the production and distribution of radioisotopes used for medical imaging, announced that it hosted a ribbon-cutting, groundbreaking and speakers event, “Molybdenum-99: Domestic Radioisotope Production Now, Expansion for the Future,” at its headquarters in Beloit, Wis. on September 19, 2019. The event commemorated nearly a year of continuous domestic molybdenum-99 (Mo-99) supply for U.S. healthcare providers, demonstrated progress on NorthStar’s expansion plans and included discussions about current and future U.S. supply of important medical radioisotopes by representatives from the U.S. Department of Energy’s National Nuclear Security Administration (DOE/NNSA), State of Wisconsin, medical societies and RadioGenix System customers. It also featured a ceremonial ribbon-cutting for NorthStar’s new isotope processing facility to further increase domestic, non-highly enriched uranium-based Mo-99 production capacity, and a groundbreaking ceremony for an electron beam accelerator facility for expanded, highly efficient Mo-99 production. The FDA-approved and commercially available RadioGenix System (technetium 99m generator) is an innovative, high tech radioisotope separation platform for use in producing the widely used medical radioisotope technetium-99m (Tc-99m) from non-uranium-based Mo-99.

Highlights of the Event
“This is an exciting time for NorthStar as we advance our plans to ensure reliable, non-uranium based radioisotope supply for the United States,” said Stephen Merrick, President and Chief Executive Officer of NorthStar. “We are appreciative to all our partners who are making this success possible: the U.S. Department of Energy’s National Nuclear Security Administration and National Laboratories, the U.S. Food and Drug Administration, the Nuclear Regulatory Commission, our private commercial investors, NorthStar’s dedicated and talented employees, our supply chain partners and our customers. In particular, we are grateful for the important contribution that our partner the University of Missouri University Research Reactor (MURR®) Team has made to our program. Additionally, the expansion activities here in Beloit are supported by Corporate Contractors Incorporated (CCI), the lead contractor for the isotope processing facility project, Von Gahlen (a leading global supplier of state-of-the-art shielding solutions for nuclear medicine and radiopharmacy) and IBA (Ion Beam Applications, a leading global supplier of accelerators, focused on bringing integrated and innovative solutions for the diagnosis and treatment of cancer).

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

“With our partners at MURR®, NorthStar is consistently providing domestic, non-uranium based Mo-99 now, and actively planning for the future. Upon appropriate licensure and FDA approval, our isotope processing facility in Beloit will augment current processing at MURR, providing dual production hubs for Mo-99. This new facility will enable us to more than double production of source vessels, which are used by radiopharmacies with RadioGenix Systems to produce Tc-99m for physicians and their patients. We are working toward final validation of two state-of-the-art fill lines at our Columbia, Missouri facility that, pending expected FDA approval, will further substantially increase the number of Mo-99 source vessels that we are able to ship to customers weekly. The first two accelerators are already ordered for our 20,000 square foot accelerator facility expansion. We plan to use the accelerators to expand production capacity, enhance production efficiencies and create dual manufacturing operations to further secure reliable, non-uranium based Mo-99 radioisotope supply for U.S. customers and patients.

Mr. Merrick continued, “NorthStar’s mission is to ‘transform medical radioisotopes,’ and we are doing that in two ways: first, by generating isotopes using stable starting material and minimizing waste; and secondly, by building efficiencies into the radioisotope production process. In addition to the facility expansions, planned RadioGenix System enhancements and ongoing R&D activities, NorthStar is making important progress in achieving its vision to be a leading medical radioisotope production company.”

In his keynote address, “Transformation of the Mo-99 Industry”, Jeffrey Chamberlin, Senior Advisor, DOE/NNSA, spoke about NorthStar’s progress in the context of larger global efforts to transform the Mo-99 industry. He said it was crucial to ensure that patients in the United States and around the world have sustainable, reliable access to critical and lifesaving medical radioisotopes, while minimizing the use of highly enriched uranium in civilian applications. Through its cooperative agreement program, DOE/NNSA partners with industry and brings U.S. government resources to bear in addressing issues around national security and medical isotope supply. The objective of DOE/NNSA’s efforts is to establish reliable supplies of Mo-99 to meet U.S. patient needs, while advancing U.S. nuclear nonproliferation policy by eliminating the use of proliferation-sensitive highly enriched uranium in medical isotope production around the world.

Mr. Chamberlin also spoke about DOE/NNSA’s experience in working with NorthStar over the past eight years and the company’s plans to be able to produce significant volumes of the U.S. demand for Mo-99 to meet patients’ needs. DOE/NNSA has provided NorthStar with funding to accelerate its efforts and made available the scientific, engineering and technical power of its National Laboratories to advance development of NorthStar’s technology. Mr. Chamberlin commented, “We are proud to work with multiple innovative cooperative agreement partners and proud to have played a role in Northstar’s transformation of this beautiful plot of land here in Beloit into a complex that will profoundly and positively affect the daily lives of many Americans. NNSA applauds NorthStar for its innovation and execution in turning its vision of producing domestic Mo-99 into a reality. Substantial progress has been made in advancing new production technologies that will allow us to diversify the means of Mo-99 production so that the industry is no longer reliant on a single-point-of-failure technology. NorthStar’s leadership in this area is evident by its development of both neutron capture and accelerator technologies.

A number of dignitaries from Wisconsin participated in the event, including Joel Brennan, Secretary of the Wisconsin Department of Administration, Lori S. Curtis Luther, Beloit City Manager and Diane M. Hendricks, Chairperson, Hendricks Holding Co., Inc. They spoke about the importance of NorthStar’s efforts to patient healthcare, the environment and national security, and the positive impact of its innovative technology in job creation and creation of economic opportunities for Beloit, Rock County and the State of Wisconsin.

Representatives from leading nuclear medicine societies spoke at the event. Dr. Munir Ghesani, MD, FACNM, FACR, NYU Langone Health, New York, NY, Advocacy Domain Chair, Government Relations Committee, Society of Nuclear Medicine and Molecular Imaging, spoke about the importance of reliable Tc-99m supply from his perspective as a practicing radiologist and professor at New York University Langone Health. Dr. Ghesani detailed the attributes that make the Tc-99m radioisotope attractive for clinical use, such as its favorable half-life, low radiation dose to patients and its ability to provide prognostic as well as diagnostic information in cardiovascular diagnostic imaging. Kathleen Flood, CEO, American Society of Nuclear Cardiology, spoke about the importance of a consistent and reliable supply of Tc-99m for cardiovascular and other medical imaging procedures. She explained that cardiac SPECT imaging, the standard of care and most widely used advanced cardiac imaging test, could not be performed for many of today’s cardiovascular patients without access to a reliable Mo-99 supply.

Customer perspectives on the medical radioisotope supply chain for Mo-99 were provided by Chris Vessel, U.S. Nuclear Medicine Supply Chain Leader, and Charlie Shanks, Principal Engineer, both of GE Healthcare. Mr. Vessel described the current global supply chain and the effects that several years of near weekly Mo-99 supply disruptions have had on radiopharmacy operations, and efforts by GE Healthcare to source new, local reliable suppliers. He spoke about how now having RadioGenix Systems available in certain GE Healthcare radiopharmacies is making a positive impact in meeting demand during supply shortages. Mr. Shanks spoke about the various ways of producing both high-specific activity Mo-99 using traditional uranium-based methods, and the low-specific activity, non-uranium based approach used in the RadioGenix System. He described features of the product including a novel, innovative sterilization system. Mr. Shanks also highlighted NorthStar’s well-executed technology development in advancing from a concept to providing real-world solutions.

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 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

INDICATION
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.

• Discard the first eluate from every new Potassium Molybdate Mo-99 Source Vessel to minimize the risk of unintended radiation exposure from Rhenium Re-186.

• 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/2019/08/radiogenix-system-pi-july2019.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 February 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.

CONTACTS:
For NorthStar Medical Radioisotopes, LLC
Corporate:
Lisa Holst
Vice President Sales and Marketing
678-471-9027
[email protected]

Media:
Priscilla Harlan
781-799-7917
[email protected]


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