BELOIT - NorthStar Medical Radioisotopes is preparing to ramp up production following federal approval earlier this year, and on Tuesday the company put the U.S. and international health care industry on notice.
The company hosted a groundbreaking event at NorthStar's corporate headquarters in the Gateway Business District in Beloit, drawing over 200 federal, state and local officials to mark the company's historic milestone and future growth.
Tuesday also marked the start of construction on a new, 20,000 square-foot facility at NorthStar's campus in Beloit on Gateway Boulevard.
In February, the company received Food and Drug Administration (FDA) approval to market its patented RadioGenix system to health-related businesses in the fight against a range of common diseases, from heart disease to cancer.
The approval marks the first domestic production of the medical radioisotope molybdenum-99 (Mo-99) in nearly three decades and avoids the use of highly enriched uranium, eliminating environmental and national security concerns. 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. 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. accounts for 50 percent of all Mo-99 and Tc-99m used in the global health care market, and officials said 40,000 injections are used daily in the country.
NorthStar CEO George Messina thanked all partners involved in the effort that started in 2002, thanking major stakeholders including Hendricks Holding founder Diane Hendricks, the U.S. Department of Energy (DOE), the Wisconsin Economic Development Corporation (WEDC) and local partners including the City of Beloit and Rock County.
"We've been at this a very long time, having some difficult times and successful times," Messina said. "This is a celebration not just for us, but for my management team, the entire staff - who are extremely dedicated - our investors and our partners."
Hendricks, who played the central role in bringing NorthStar to Beloit, said Tuesday's ceremony was a historic day for NorthStar and the City of Beloit.
"I think the proudest aspect of this accomplishment is that this is capitalism at its very best," Hendricks said. "This is the federal government giving private enterprise initiative to come up with new products and ideas."
Beloit City Manager Lori Curtis Luther said Tuesday that NorthStar's work created "significant versatility" to Beloit's "high-tech sector."
The DOE played a major part in getting NorthStar's research off the ground, providing $25 million in matching funds of a $50 million partnership agreement. Messina said the DOE's role was invaluable.
"Their effort in supporting us took on a tremendous amount of research and development that actually made it possible to go forward," Messina said.
DOE Under Secretary for Nuclear Security Lisa E. Gordon-Hagerty said NorthStar's federal green light was a "turning point" for national security in the country and the wider U.S. medical community.
"This issue is a deeply personal one for most Americans," she said. "It empowers us to fight back. It enables us to diagnose heart disease, study organ function and detect the spread of cancer."
At year's end, the company hopes to account for 10 percent of its possible supply market, with Hagerty estimating that NorthStar could supply up to two-thirds of the country's domestic supply in the years ahead. To accommodate growth, new hires are expected to NorthStar's team.
As the company prepares for potential production this summer, NorthStar looks to improve the RadioGenix system to meet future FDA approvals of other isotopes related its HIV and cancer therapy developments.
"We're working on those on the sidelines and we are working on them diligently," Messina said. "The clinical trials so far to-date have been really, really remarkable."
Messina said NorthStar Chief Science Officer Jim Harvey is developing technology that could "do multiples" of treatments currently available to patients fighting HIV, of which Messina pegged at around 100 patients a year. The low figure stems from the fact there's a limited supply of two rare isotopes central to current treatment methods, he added.
"We're in the process to get that set up," Messina said. "We hope that is the next level of growth you will be seeing here in Beloit."