NorthStar Medical Radioisotopes, LLC formerly of Madison, Wisconsin now headquartered in Beloit, is the recipient of a $15 million cooperative agreement award from the U.S. Department of Energy’s National Nuclear Security Administration (DOE/NNSA).
This funding on July 23rd, is part of ongoing support by the DOE/NNSA to establish a stable domestically produced non-uranium-based source of molybdenum-99 (Mo-99), from which the most commonly used radioisotope for medical diagnostic imaging procedures, technetium-99 (Tc-99m), is derived. The award is matched by an investment of $15 million from the company for a total of $30 million for this session. This brings the funding from the government to $65 million, matched by NorthStar for a total of $130 million in cooperative agreements between both entities.
The company plans to use the funds awarded to refine its neutron capture technology to produce the Mo-99 isotope from natural or enriched sources of molybdenum-98, (nMo-98 or eMo-98) and for enhancements to its FDA-approved RadioGenix® System. This system is a Tc-99m generator that is used to produce US Pharmacopeia standard Sodium Pertechnetate Tc-99m, a radioactive agent that is required in the preparation of radiopharmaceuticals used for diagnostic procedures.
NorthStar Medical Radioisotopes, LLC also completed construction on a 20,000 square foot expansion of its facility in Beloit in July. According to a recent press release, the company has plans to build a particle accelerator later this year for the neutron knock-out production of Mo-99 from enriched naturally occurring Mo-100 (eMo-100).
Tc-99m is a metastable radioisotope that is better suited for diagnostic than therapeutic use due to its short physical half-life (93.7% decays with the emission of readily detectable gamma radiation to the less potent more stable Tc-99 in 24 hours) and a biological half-life (metabolized by the human body) of 1 day. It is thus conveniently used as a radioactive tracer in tens of millions of medical imaging procedures annually for the evaluation of a range of conditions from cancer to heart disease. Diagnostic data can be rapidly collected and assessed while keeping patient exposure to radiation relatively low.
Conventionally, the majority of Mo-99, the parent isotope of Tc-99m, is sourced from aging facilities outside of the U.S. where it is generated during the fission of highly enriched uranium (HEU), the same uranium that can also be used in the production of nuclear weapons. The Mo-99 isotope is stable for transportation to nuclear medicine sites where it can be converted to Tc-99m for clinical applications. A high-tech radioisotope separation platform such as NorthStar’s innovative RadioGenix® System can be employed for this purpose.
Reliance on HEU-base Mo-99 from foreign sources poses a variety of significant concerns for U.S. users ranging from environmental safety, to national security and patient vulnerability should a shortage occur. There has been no reliable domestic source of Mo-99 in the U.S. for over 25 years. Consequently, initiatives to produce Mo-99 within the country without HEU are in great demand.
According to NorthStar’s website, the company “aims to create and deploy novel radioisotope production technologies, instrumentation and associated disposables for radionuclide separation for commercial and academic suppliers of radiopharmaceuticals throughout the United States,” thus becoming a key reliable domestic supplier of Mo-99 that can meet the demands of the nuclear medical system. Their solution would also be environmentally friendly as their waste streams would be free of the toxic and radioactive byproducts of uranium-based processes.
In a recent press release, Stephen Merrick, current President and Chief Executive Officer of NorthStar confirmed, “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.”
NorthStar Medical Radioisotopes, LLC, was founded in 2006 by engineers, George Messina, now retired President and CEO, and Glen Isensee, former Senior Vice President and CTO. The company is a wholly-owned subsidiary of NorthStar Medical Technologies, LLC.
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