BELOIT, Wis.–(BUSINESS WIRE)–NorthStar Medical Radioisotopes, LLC, a company involved in the production and distribution of radioisotopes used for medical imaging, today announced that it received an Award for Outstanding Achievement from the U.S. Department of Energy’s National Nuclear Security Administration (NNSA). The award recognizes NorthStar for being the first producer of molybdenum-99 (Mo-99) in the United States in nearly 30 years. It was presented on behalf of NNSA by Peter H. Hanlon, Assistant Deputy Administrator, Office of Material Management and Minimization, at NNSA’s 2018 Annual Mo-99 Topical Meeting held in Knoxville, Tenn., September 23-26, 2018. Approved by the U.S. Food and Drug Administration (FDA) in February 2018, NorthStar’s RadioGenix® System is an innovative, high tech radioisotope separation platform indicated for use in producing the widely used medical radioisotope technetium-99m (Tc-99m) from non-uranium based molybdenum-99 (Mo-99).
NorthStar participated in several key sessions at the meeting. The Opening Plenary Session, “Supporting a Reliable, Non-HEU Mo-99 Supply,” featured a presentation by James Harvey, PhD, SVP and Chief Science Officer of NorthStar Medical Radioisotopes, who spoke about “Lessons Learned: Path to Approval.” Dr. Harvey later presented an update on domestic production of Mo-99 via neutron capture in a session devoted to Mo-99 production projects and technologies.
“We are pleased to recognize NorthStar Medical Radioisotopes’ outstanding achievement for being the first producer of Mo-99 in the United States in nearly 30 years,” said Peter H. Hanlon, Assistant Deputy Administrator, Office of Material Management and Minimization, NNSA, while presenting the Award for Outstanding Achievement at NNSA’s 2018 Annual Topical Meeting. “NorthStar’s success directly supports the National Nuclear Security Administration’s goal to reduce the use of highly enriched uranium in civilian commercial applications. NorthStar’s efforts have resulted in a safer world while contributing to a stable supply of this crucial medical radioisotope for American patients.”
“NNSA has partnered with NorthStar Medical Radioisotopes for seven years to develop the RadioGenix System and modernize the neutron capture process for the production Mo-99 without the use of uranium,” said George Messina, Chairman Emeritus of NorthStar Medical Radioisotopes. “It’s gratifying that our efforts became realized through the FDA’s approval of the RadioGenix System. NNSA’s close collaboration, outstanding working relationship and support of NorthStar have been instrumental in achieving this success.”
“In addition to sincere appreciation for the support and efforts of NNSA, I would like to recognize and thank our partners at the University of Missouri Research Reactor (MURR®) for their important contribution to the success of this project,” said Stephen Merrick, President and CEO of NorthStar Medical Radioisotopes. “As a result of this highly successful collaboration between government, academia and industry, NorthStar has reached a transformative inflection point in our mission to provide a reliable supply of Mo-99 produced without uranium to meet U.S. healthcare needs and strengthen national security. The commercial launch of the RadioGenix System is well underway, and we are ramping up expansion activities to further increase production capacity for domestically-produced Mo-99.”
The Mo-99 Topical Meeting is intended to serve as a workshop where international and domestic policy and technical experts can gather to present and discuss progress toward achieving the production of Mo-99 without the use of highly enriched uranium (HEU) in support of nonproliferation objectives and global reliability of supply.
Partial funding for NorthStar’s technology was provided by the U.S. Department of Energy’s National Nuclear Security Administration. Under provisions of the American Medical Isotopes Production Act of 2012, efforts have been made to establish domestic production of Mo-99 and to promote the use of Mo-99 produced without reliance on highly enriched uranium, which is a nuclear proliferation risk. NorthStar’s technology uses stable isotopes of molybdenum, rather than enriched uranium, thereby avoiding the national security and environmental risks associated with enriched uranium.
About the RadioGenix® System
The RadioGenix System is an innovative, high tech system 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 February 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.
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 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: