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July 23rd, 2019   /   Press Releases

NorthStar Medical Radioisotopes Awarded $30 Million Cooperative Agreement by U.S. Department of Energy’s National Nuclear Security Administration to Expand Domestic Molybdenum-99 (Mo-99) Production


– Supports enhancements for commercially available RadioGenix® System and technology to increase NorthStar’s current production capacity of non-uranium based Mo-99 –

BELOIT, Wis. – July 23, 2019 – NorthStar Medical Radioisotopes, LLC, a global innovator in the production and distribution of radioisotopes used for medical imaging, today announced that it has been awarded $15 million in a cooperative agreement with the U.S. Department of Energy’s National Nuclear Security Administration (DOE/NNSA) as part of an industry outreach initiative to establish reliable domestic molybdenum-99 (Mo-99) production without the use of highly enriched uranium. NorthStar will use funds from the award to further advance its current neutron capture technology which enables non-uranium based production of the important medical radioisotope Mo-99. Funds will also be used in continuing development of enhancements for the FDA-approved and commercially available RadioGenix System (technetium 99m generator). The RadioGenix System uses reliable, domestic, non-uranium based Mo-99 to supply physicians and their patients with the most widely used diagnostic imaging radioisotope, technetium 99m (Tc 99m).

“We greatly appreciate this new cooperative agreement award and the continued financial and technical support provided by DOE/NNSA, which will help NorthStar expand Mo-99 production capacity and efficiency, as well as support enhancements to the RadioGenix System to continue optimizing utility in radiopharmacies,” said Stephen Merrick, President and Chief Executive Officer of NorthStar. “Like DOE/NNSA, NorthStar shares a vision of protecting national security and the environment while providing the nuclear medicine community and the patients it serves with a reliable domestic supply of Mo-99 produced without highly enriched uranium.”

Mr. Merrick continued, “In conjunction with the RadioGenix System being increasingly used commercially, NorthStar is already producing domestic, non-uranium based Mo-99 and we are actively executing on our plans to expand our capacity to meet future needs. Construction is complete on our 20,000 square foot facility expansion in Beloit, Wis., which we believe will more than double production capacity for Mo-99 Source Vessels upon equipment installation and FDA approval. Additionally, pending expected FDA approval this year, two state-of-the-art fill lines at our Columbia, Mo. facility will increase the number of weekly Mo-99 Source Vessel shipments we are able to deliver to customers. Finally, I want to recognize the tremendous job our partners at the University of Missouri Research Reactor (MURR®) have done to help ensure that Mo-99/Tc-99m is available for radiopharmacies, healthcare providers, and, most importantly, patients.”

DOE/NNSA supports the establishment of a reliable domestic supply of Mo-99 produced in the United States without the use of highly enriched uranium (HEU), and with support from Congress, is providing $15 million for each of four cooperative agreements awarded under a recent Funding Opportunity Announcement. As with all DOE/NNSA cooperative agreements for domestic Mo-99 partners, DOE/NNSA matches NorthStar funding dollar for dollar, with the current agreement capped at a $30 million total in funds from both parties. NorthStar was selected by DOE/NNSA based on the evaluations and recommendations of an independent technical review panel. With inclusion of the current and past awards, NorthStar has been awarded a total of $65 million in cooperative agreements by DOE/NNSA.

“NorthStar’s enriched Mo-98 neutron capture program is one facet of our multi-pronged approach to increase domestic Mo-99 production capacity across multiple processing platforms, and we anticipate that the program will enable at least a four-fold increase in our Mo-99 production capability, pending appropriate licensures and regulatory approval,” said James T. Harvey, PhD, Senior Vice President and Chief Science Officer at NorthStar. “Enriched Mo-98 is produced by increasing the concentration of the Mo-98 isotope in natural molybdenum to more than 95% Mo-98. Then, using neutron capture technology, the enriched Mo-98 is converted to the medically useful radioisotope, Mo-99. Like other NorthStar Mo-99 processes, our Mo-98 neutron capture methodologies are non-uranium based.”

About DOE/NNSA
Established by Congress in 2000, NNSA is a semi-autonomous agency within the U.S. Department of Energy responsible for enhancing national security through the military application of nuclear science. NNSA maintains and enhances the safety, security, and effectiveness of the U.S. nuclear weapons stockpile without nuclear explosive testing; works to reduce the global danger from weapons of mass destruction; provides the U.S. Navy with safe and effective nuclear propulsion; and responds to nuclear and radiological emergencies in the U.S. and abroad. Visit energy.gov/nnsa for more information.

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 Medical Radioisotopes – Molybdenum-99 (Mo-99) and Technetium-99m (Tc-99m)
Tc-99m is a radioisotope used in a variety of diagnostic testing procedures. It is currently the most widely used medical radioisotope in the United States, used in more than 10 million diagnostic procedures annually. Tc-99m-based radiopharmaceuticals are used to diagnose and stage heart disease, cancer, infection, inflammation and other conditions.

Tc-99m is derived from the radioisotope Mo-99. The United States uses about 50% of the world’s Mo-99/Tc-99m for medical purposes, but U.S. supply of Mo-99 has been completely reliant on foreign sources and subject to frequent and sometimes protracted interruptions which negatively impact patient healthcare. Other Mo-99 producers continue to use enriched uranium in their processing which poses significant environmental concerns. NorthStar’s technology uses stable isotopes of molybdenum to produce Mo-99 domestically without incurring the concerns related to the management of toxic waste associated with Mo-99 production from enriched uranium.

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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