NorthStar Medical Radioisotopes LLC signed a non-exclusive letter of intent with GE Healthcare on Friday, which entails that NorthStar will supply GE with Molybdenum-99 (Mo-99) when its RadioGenix isotope separation system gets FDA approval.
NorthStar also signed a similar agreement with Triad Isotopes, Inc. in June.
"Continuity of supply of 99Mo to meet the growing demand for diagnostic procedures is a key focus for GE Healthcare," Julie Woodland, global product leader at GE, said in a statement. "The company is actively working with new alternative 99mTc sources to help ensure that access to the radioisotope is readily available to aid in the diagnosis of patients both today and in the future."
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Mo-99 is the parent isotope of Technetium-99m — the most commonly used radioisotope in medical diagnostic imaging. NorthStar is working on creating a domestic source of Mo-99 to ease the constant shortage of it.
"80 percent of the diagnostic nuclear medicine studies performed in the United States today are done with Tc-99m," Ed Fennell, vice president of business development at NorthStar, told DOTmed News. "It's a major component of nuclear medicine."
Almost all Mo-99 is being produced with weapons-useable highly enriched uranium at aging facilities outside of the U.S. Because of that, there have been product shortage and safety and national security concerns.
However, NorthStar will be producing the isotope without using weapons-useable HEU and they only produce a mild amount of waste. Other than quelling the shortage, it was also to help meet the goals set by the U.S. Department of Energy's Global Threat Reduction Initiative.
Those goals aim to lessen and protect vulnerable nuclear and radiological material that's in civilian sites around the world and to reduce the use of HEU in civilian applications.
Fennel said that they are working with all of the major radiopharmacy companies to supply them with Mo-99.
NorthStar expects RadioGenix to receive FDA approval in the last quarter of next year.