Image courtesy of NorthStar Medical Radioisotopes LLC
March 17, 2015 — NorthStar Medical Radioisotopes LLC will unveil the commercial model of its RadioGenix isotope separation system during three events on March 27 and March 28 at The Keating Hotel in San Diego. The events will be the first public demonstrations of system enhancements directly inspired by recommendations made by nuclear pharmacists during similar events last year.
The RadioGenix — which is currently under consideration by the U.S. Food and Drug Administration and which NorthStar plans to introduce to the market in the near future — will create the United States’ first domestic supply of technetium-99m (Tc-99m) in more than 45 years. Technetium-99m is the most widely used radioisotope in medical diagnostic imaging. The RadioGenix system will produce high specific activity Tc-99m from low specific activity molybdenum-99 (Mo-99).
NorthStar has two proprietary processes for producing Mo-99 in the United States without the use of highly enriched uranium (HEU). These processes may well overcome the chronic shortage of this critical isotope that has plagued the nuclear medicine industry for a half-dozen years. Currently, nearly all Mo-99 is generated using weapons-useable HEU at aging facilities located outside of the United States, leading to product shortages and creating safety and national security concerns.
The RadioGenix system automates the on-site isotope separation process and includes safety features that are absent from all other systems currently on the market. These features include periodic on-site sterilization of fluid pathways, disposable sterility filters and an automated filter integrity test prior to each elution.
During the unveiling events, company executives and service engineers will provide demonstrations and discuss enhancements made to the system over the past year. The improvements – most notably to the source vessel containment unit, the stainless steel covering and the liquid phase sterilization unit – are direct responses to recommendations made by nuclear pharmacists who saw a developmental model of the system during last year’s events.
Event attendees can also learn more about the early adopter program that NorthStar expects to begin later in 2015
For more information: www.northstarnm.com