FDA Approves NorthStar Medical to Make Isotope Generator at WI Plant

A Wisconsin company seeking to become the first domestic producer in decades of a crucial medical isotope said Tuesday that it received another key approval from the FDA.

NorthStar Medical Radioisotopes said the agency approved a still-to-be-built facility at the company’s Beloit, WI, headquarters to manufacture a device that could be key to supplying a radioisotope, the scarcity of which has sparked concern because it is so widely used in medical imaging.

NorthStar’s latest announcement comes five months after the company said the FDA approved the device NorthStar plans to manufacture, called the RadioGenix System. It’s designed to decay an isotope (molybdenum-99) into technetium-99m, the most widely used radioisotope in medical diagnostic imaging.

Technetium-99m is used in at least 20 million imaging procedures in the U.S. each year, according to Massachusetts General Hospital’s Proto Magazine. The isotope is used in many cardiac stress tests and bone scans, for example.

In February, the Nuclear Regulatory Commission said it had approved the technetium-99m generated by NorthStar’s RadioGenix device “to be injected intravenously, instilled into the bladder or eye, or used with other FDA-approved imaging drugs to examine specific tissues and organs.”

NorthStar has already produced test batches of molybdenum-99 at a nuclear reactor in Columbia, MO, as part of a collaboration between the company and the University of Missouri Research Reactor.

NorthStar’s plan for the next three years is to sell its RadioGenix device to nuclear pharmacies across the country, along with molybdenum-99 produced at the Missouri reactor.

In its announcement that the FDA approved NorthStar’s plant to manufacture RadioGenix devices, NorthStar CEO George Messina said his company has scheduled the first installation of one of the devices at a customer site. NorthStar is not making public the organization’s name, nor is it saying when the install will kick off, according to a spokesperson for NorthStar.

The company’s long-term vision is to produce both RadioGenix devices and molybdenum-99 in Wisconsin. Earlier this year, the Janesville Gazette reported NorthStar will not begin making molybdenum-99 at its headquarters until 2021 at the earliest.

Trending on Xconomy