Eden files NRC permit for Mo-99 isotope facility

Eden Radioisotopes has filed a construction permit application with the U.S. Nuclear Regulatory Commission for a medical isotope production complex in New Mexico.

The Albuquerque-based company said the proposed facility near Eunice, NM, is designed to produce molybdenum-99, or Mo-99, along with therapeutic and diagnostic isotopes including lutetium-177, copper-64, and terbium-161.

Mo-99 is the parent isotope of technetium-99m, which is used in more than 40,000 diagnostic imaging procedures performed daily in the U.S., according to Eden. The company said the U.S. currently imports all of its Mo-99 from foreign reactors, creating a supply-chain risk because the isotope decays within hours to days and cannot be stockpiled.

If approved and completed, the New Mexico facility would be positioned to supply up to 50% of global Mo-99 demand, Eden said. The company also projected capacity for more than 3.5M annual doses of therapeutic isotopes, including Lu-177.

The facility is based on an all-target reactor concept exclusively licensed from Sandia National Laboratories. Eden said the reactor is designed for high-yield isotope production and would be able to produce both fission-product and activation radioisotopes for diagnostic and therapeutic use.

The NRC says construction permit applications for medical radioisotope irradiation and processing facilities include an environmental report and preliminary safety analysis report. The agency states that staff reviews of those parts generally run simultaneously over about 18 to 24 months after the application is accepted for review. 

Eden said it expects a 12-month NRC review timeline, citing early engagement with the regulator, environmental due diligence, and its safety design. The company’s projected timeline is therefore more aggressive than the NRC’s general review estimate for this type of application.

“For decades, the American medical system has operated at the mercy of a fragile, foreign-dependent supply chain,” said Eden CEO Carrie Freeman.

The application comes as U.S. nuclear medicine groups and isotope suppliers continue to focus on domestic production capacity. Supply disruptions for Mo-99 can affect access to technetium-99m studies, including common cardiac, bone, renal, hepatobiliary, and other nuclear medicine exams.

Eden’s broader plan also targets the therapeutic radiopharmaceutical market. Lu-177 is used in radioligand therapy, while Cu-64 and Tb-161 are being studied or used in molecular imaging and theranostic development.

Further progress will depend on NRC review, permitting, construction, and eventual operating authorization. Eden said its reactor concept is designed to generate no spent fuel.