March 20th, 2013 / Press Releases
NorthStar Medical Technologies Files New Drug Application with FDA
MADISON, WI – March 20, 2013 – NorthStar Medical Technologies, LLC, (NorthStar) announced that it has submitted a New Drug Application (NDA) with the Food and Drug Administration (FDA). The FDA has accepted the application for review. The submission is for NorthStar’s TechneGen™ Generator System, which will allow nuclear pharmacies to process radioisotopes for critical medical procedures using NorthStar’s natural, non-uranium based Molybdenum-99 (Mo99) as source material.
Mo99 is the parent isotope of Technetium-99m (Tc99m), an element used in approximately 85 percent of diagnostic imaging procedures. Currently, Mo99 is supplied entirely via importation from foreign nuclear reactors using Highly Enriched Uranium (HEU). NorthStar will become the first domestic supplier of Mo99 in the United States, and the first to produce Mo99 without the use of any uranium. The TechneGen Generator System allows for the efficient, on-site separation and dose preparation of Tc99m from Mo99.
“We are very pleased to announce the New Drug Application to the FDA for our TechneGen Generator System,” said George Messina, NorthStar’s CEO. “We look forward to bringing this product to market, and accelerating the delivery of a smarter, more sustainable approach to nuclear medicine in the U.S.”
About NorthStar Medical Technologies, LLC
NorthStar Medical Technologies, LLC is the parent company of NorthStar Medical Radioisotopes, LLC, which was founded in 2006 to address the needs of the nuclear medicine market in the United States. The company is committed to resolving supply challenges that have plagued the industry and have challenged production supply, thereby stalling clinical research. NorthStar’s patented technologies include innovative non-uranium based Molybdenum-99 production methods, a novel separation chemistry system, and tools for the nuclear medicine market. Learn more at www.northstarnm.com.