Representatives from the U.S. Department of Energy’s National Nuclear Security Administration and State of Wisconsin Join NorthStar Medical Radioisotopes’ Groundbreaking and Speaker Event
– Event recognizes recent U.S. Food and Drug approval of NorthStar’s RadioGenix™ System for use in producing the widely used medical isotope technetium-99m (Tc-99m) from non-uranium produced molybdenum-99 (Mo-99), the first domestic production in more than 25 years –
BELOIT, Wis. – April 30, 2018 – NorthStar Medical Radioisotopes, LLC (NorthStar), a company involved in the production and distribution of radioisotopes used for medical imaging, announced that it hosted an event commemorating recent U.S. Food and Drug Administration approval of its RadioGenix™ System. It included a ceremonial groundbreaking for NorthStar’s new facility to further increase domestic, non-uranium based molybdenum-99 production capacity. Speakers included a representative from the U.S. Department of Energy’s National Nuclear Security Administration (NNSA), the State of Wisconsin, economic development agencies and local officials. The event, “A New Era in U.S. Mo-99 Supply,” was held at NorthStar’s corporate headquarters in Beloit, Wis. on April 17, 2018. The RadioGenix™ System is an innovative, high tech radioisotope separation platform indicated for use in producing the widely used medical radioisotope technetium-99 (Tc-99m) from NorthStar’s non-uranium based molybdenum-99 (Mo-99).
Lisa E. Gordon-Hagerty, the U.S. Department of Energy’s Under Secretary for Nuclear Security and Administrator of the National Nuclear Security Administration, spoke about “Strengthening Our Nation through Nuclear Security.” Additional dignitaries included Rebecca Kleefisch, Wisconsin Lt. Governor; Mark R. Hogan, Secretary and CEO, Wisconsin Economic Development Corporation; Lori S. Curtis Luther, Beloit City Manager and Diane M. Hendricks, Chairman, Hendricks Holding Co., Inc.
“The FDA’s recent approval of the RadioGenix System means that NorthStar can begin providing its customers with a reliable, domestic and environmentally friendly supply of the Mo-99 radioisotope for the United States,” said George P. Messina, Chairman and CEO of NorthStar Medical Radioisotopes. “We are extremely proud to pioneer domestic production of Mo-99 that is independent of uranium-based product to reduce the U.S. healthcare system’s reliance on fragile foreign supply of Mo-99. NorthStar is committed to protecting national security and the environment while providing innovative products for the nuclear medicine community and the patients it serves. We are extremely grateful to all our partners in success in achieving this tremendous milestone: the U.S. Department of Energy’s National Nuclear Security Administration, the U.S. Food and Drug Administration, the Nuclear Regulatory Commission, our private commercial investors, NorthStar’s dedicated and talented employees and our supply chain partners. In particular, we would like to recognize the important contribution that the Missouri University Research Reactor (MURR) Team has made to our program.”
“I am very proud of the role NNSA has played in its unique public-private partnership with NorthStar,” said Lisa E. Gordon-Hagerty, the U.S. Department of Energy’s Under Secretary for Nuclear Security and Administrator of the National Nuclear Security Administration. “NorthStar’s innovative process will not use highly enriched uranium for medical isotope production. What it will do is save lives, create jobs, and strengthen our national security. As many of you may know, NNSA provided NorthStar with funding to accelerate its efforts to bring this project to market. NNSA also made available the scientific, engineering and technical power of our National Laboratories to advance the development of NorthStar’s technology, and as a result, NorthStar is the first company in the United States to supply Mo-99 for patient use since the 1980s.”
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 Safety Information About the RadioGenix™ System and Sodium Pertechnetate Tc 99m Injection USP
RadioGenix™ System is a technetium Tc-99m generator used to produce sterile, non-pyrogenic Sodium Pertechnetate Tc 99m Injection. Sodium Pertechnetate Tc-99m Injection is indicated for use 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 Urinary Bladder Imaging (direct isotopic cystography) for detection of vesicoureteral reflux.
IMPORTANT SAFETY INFORMATION
• Radiation Exposure Risk: Sodium Pertechnetate Tc-99m injection contributes to a patient’s long-term cumulative radiation exposure. Ensure safe handling to protect patients and health care workers from unintentional radiation exposure.
• Unintended Mo-99 Exposure: 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 0.15microCi of Mo-99/mCi of Tc-99m limit has been reached and discard the Sodium Pertechnetate Tc-99m Injection when the 12 hour expiration time is reached; whichever occurs earlier.
• Hypersensitivity Reactions: Monitor all patients for hypersensitivity reactions.
• Adverse Reactions: Allergic reactions, including anaphylaxis, have been reported infrequently following the administration of Sodium Pertechnetate Tc 99m Injection.
To report SUSPECTED ADVERSE REACTIONS, contact NorthStar Medical Radioisotopes, LLC at 1-844-438-6659 or contact FDA at 1-800-332-1088 or www.fda.gov/medwatch.
Full RadioGenix prescribing information is available at: www.northstarnm.com.
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.
For NorthStar Medical Radioisotopes, LLC
Vice President Sales and Marketing
For NorthStar Medical Radioisotopes, LLC