BELOIT - NorthStar Medical radioisotopes has been green-lit by the U.S. Food and Drug Administration (FDA) to proceed with marketing its patented technology to supply products widely used in diagnostic medical imaging for combating cancer and other ailments, according to a company news release.
NorthStar was notified of the FDA approval Thursday, with the move signaling the first domestic production of valuable medical radioisotope molybdenum-99 (Mo-99) in more than 25 years, company officials said.
FDA approval was the company's final regulatory barrier before production could officially begin. The company is also seeking FDA approval on its methods of shipping other isotopes to radiopharmacy labs across the country, with the company's patented transport device, RadioGenix, to be used for point-of-care uses on patients.
NorthStar expects to be shipping products within "several weeks of FDA approval," the news release said.
"...we are extremely proud to pioneer domestic production of Mo-99 that is independent of uranium-based product," said NorthStar Chairman and CEO George Messina. "The approval by the FDA will reduce the U.S. healthcare system's reliance on fragile foreign supply of Mo-99 and the use of enriched uranium target material."
The company's technology can be used to separate Mo-99 from Technetium-99 (Tc-99m), the most widely used isotope in radio-medical imaging.
By working around using low-enriched uranium, NorthStar is able to reduce the amount of waste byproduct and recycle its source vessels used for transporting the isotopes used by doctors and lab technicians across the country.
"NorthStar's processes are based on proven, well-established principles, as exemplified by our neutron capture production process, and marks a significant technological advancement to current technology," said James Harvey, NorthStar Senior Vice President and Chief Science Officer.
Tc-99 is used in around 40 million procedures worldwide each year to diagnose and stage cancer, heart disease, infection and inflammation. The U.S. also accounts for 50 percent of all Mo-99 and Tc-99m used in the global health care market, Harvey said in a Beloit Daily News interview in January 2017.
NorthStar's production process sources Mo-99 from the Missouri University Research Reactor (MURR), with source vessels being made in Beloit, and then being sent to the radiopharmacy, hospital or imaging center. Following its use on a patient, the vessel will be shipped back to NorthStar to send the container back to MURR to be reused.
Currently international supply of the isotopes mostly rely on outdated nuclear reactors for production, with NorthStar officials saying the domestic supply chain for Mo-99 "has been subject to frequent and sometimes severe interruptions which negatively impact patient healthcare," the news release said.
Currently NorthStar has at least $100 million in funding for its research and development efforts. The funding comes in part from $50 million in private investments and matching funds of $50 million from the National Nuclear Security Administration (NNSA) agency within the U.S. Department of Energy (DOE) for two cooperative agreements regarding the company's production methods.
Company officials previously told the Beloit Daily News that NorthStar would look to add more facilities to its Beloit location. The current, 33-acre site on Gateway Boulevard can accommodate over 150,000 square-feet of new building space, with officials estimating expansion efforts would occur over the next 10 years.
For more information on the company, northstarnm.com