BELOIT — NorthStar Medical Radioisotopes officials say the company is about six to nine months away from netting approval by the U.S. Food and Drug Administration (FDA) with its patented technology to supply and transport products widely used in diagnostic medical imaging for combating cancer and other ailments.
Executives from the nuclear medicine company expect the firm to be the first domestic supplier of Molybdenum-99 (Mo-99), an isotope used in medical imaging tests. The company’s main technology can be used to separate M-99 from Technetium-99 (Tc-99m), the most widely used isotope in radio-medical imaging, without using any uranium in its process. 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 Chief Operating Officer Stephen Merrick said.
“We’re following the FDA’s road map to approval exactly as it has been defined to us by them,” said NorthStar CEO George Messina. “We are seventy-five percent of the way to getting FDA approval.”
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, according to NorthStar Chief Science Officer Jim Harvey.
The company’s final submission to the FDA will be made at the end of March, and in preparation for the submission, NorthStar has completed 29 production runs, while producing multiple batches of Mo-99 and Tc-99m. To accompany the tests, NorthStar has been shipping its dosage containers for over a year.
“We’ve been working far longer than anyone else,” Harvey said. “We’re much farther ahead and we have a more efficient process.”
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 radio-pharmacy, 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 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.
“We have excellent supporters,” Messina said. “The Hendricks Holding Company has been a really great supporter of what we do. While the competition wants to get the DOE to guarantee loans for them, Hendricks does that for us. They believe in everything that we are doing.”
Messina also confirmed the company is in the design stages of adding more facilities to its Beloit location, which is slated to be the company’s flagship headquarters over the next 18 months. The 33-acre site on Gateway Boulevard can accommodate over 150,000 square feet of building space. The expansion efforts are expected to take place over 5 to 10 years. Messina could not confirm specific future plans to expand internationally, but Merrick added the company’s production technology could be applied globally.
For more information on NorthStar, visit northstarnm.com.