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April 14th, 2020   /   Press Releases

World Council on Isotopes Honors NorthStar Medical Radioisotopes with President’s Award


– Award Recognizes Outstanding Contributions to Isotopes and Their Uses to Benefit Mankind –

BELOIT, Wis., April 14, 2020 — NorthStar Medical Radioisotopes, LLC, a company involved in the production and distribution of radioisotopes used for medical imaging, today announced that it has received the President’s Award from the World Council on Isotopes (WCI). The award was presented in recognition of NorthStar’s commitment, dedication and “outstanding contributions to isotopes and their uses to benefit mankind.” Professor Jong Kyung Kim, incoming President of the WCI, made the presentation at the 10th International Conference on Isotopes, held in Kuala Lumpur, Malaysia, in February, 2020.

“We are honored that the WCI has presented NorthStar Medical Radioisotopes with its prestigious President’s Award,” said Steve Merrick, President and CEO of NorthStar Medical Radioisotopes. “NorthStar is aligned with WCI’s mission to promote the safe and environmentally sound use of isotope technologies for global wellbeing. Our commercially available RadioGenix® System (technetium Tc 99m generator) processes non-uranium based molybdenum-99 (Mo-99), produced in partnership with the University of Missouri Research Reactor (MURR®), to produce technetium-99m (Tc-99m), which is currently the most widely used diagnostic radioisotope for medical purposes. RadioGenix Systems are increasingly providing the United States with access to reliable, non-uranium based Mo-99 supply. NorthStar continues to expand production capacities to ensure adequate Mo-99 supply to meet patient needs, while simultaneously advancing commercial production technologies for therapeutic radioisotopes such as actinium-225 and copper-67.”

 

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/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.

• Unintended Re-186 Exposure: 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 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 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.
For Full RadioGenix® System version 1.2 Prescribing Information, click here or visit https://www.northstarnm.com/wp-content/uploads/2020/04/RadioGenix-System-verison-1.2-PI-Oct-2019-rev-00.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 (technetium Tc 99m generator), 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]

Investor Relations:
Paul Estrem
Senior Vice President and Chief Financial Officer
608-987-8318
[email protected]

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


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