Production is set to rise at NorthStar Medical Radioisotopes’ facility in Beloit, where the precursor material for an important medical imaging agent is being made.
The company got FDA approval early last year for its RadioGenix system, which is used to derive Tc-99m, a commonly used imaging agent, from a material called molybdenum-99, or Mo-99. Approval was also granted for domestic production of Mo-99.
Since then, NorthStar has begun the roll out process for RadioGenix, and the first units are now being used by radiopharmacy customers to turn Mo-99 into Tc-99m.
Since Tc-99m decays very quickly, NorthStar’s customers use the system to produce the imaging agent on demand. And there’s no shortage of demand, as Tc-99m is the most widely used diagnostic medical isotope in the country.
A release from the company shows “numerous” RadioGenix commercial sites are in the regulatory review process, and “many additional sites” are anticipated for this year.
To continue that momentum, NorthStar’s Beloit facility is being expanded by 20,000 square feet, with construction “well underway.” Once new equipment is installed and the facility is again approved by the FDA, the company expects to more than double its capacity for Mo-99 production.
“Every week, a significant and growing number of Tc-99m patient doses are dispensed using RadioGenix Systems and non-uranium Mo-99, with market uptake continuing to be strong and growing,” said Stephen Merrick, President and CEO at NorthStar.
He also notes that NorthStar has been recognized by the U.S. Department of Energy’s National Nuclear Security Administration as the first U.S. producer of Mo-99 in about 30 years.
Merrick says NorthStar is also “working toward final validation” of two fill lines at a facility in Missouri. With FDA approval expected this year, he says the new lines will increase the amount of Mo-99 the company can ship.
“We are further planning for the future by investing in additional Mo-99 production capacity and enhancements to the RadioGenix System,” he said.
The company currently has 160 employees, and continues to expand. Late last year, Beloit businesswoman Diane Hendricks was named board chair of NorthStar, which got its start in 2011 with an initial investment from Hendricks Holding Company.
See a previous story on NorthStar: http://wisbusiness.com/index.Iml?Article=390365
–By Alex Moe