Burnaby, Canada, April 1, 2025 – Telix ARTMS, Inc. (ARTMS), a global leader in radioisotope production technologies, is pleased to announce that the drug master file (DMF)[1] for gallium-68 production using its QUANTM Irradiation System® (QIS®) cyclotron technology has been referenced for the first time with a United States (U.S.) Food and Drug Administration (FDA) approved product, with Gozellix® (kit for the preparation of gallium-68 (⁶⁸Ga) gozetotide injection).

This approval will enable radiopharmacies and hospitals using ARTMS’ QIS® cyclotron technology and associated targets to produce multi-Curies of ⁶⁸Ga for use with Gozellix®. The expanded distribution radius and increased dose production capacity, compared to existing gallium-based PET tracers, will facilitate broader and more equitable access. In addition, use of ARTMS’ technology is being expanded internationally where regulatory submissions are in preparation. Pharmaceutical companies will be able to reference ARTMS’ standardized isotope production technology with their approved drugs, helping to localize and simplify manufacturing.

Chad Watkins, General Manager ARTMS and Isotope Strategy, Telix, said, “This DMF reference represents a significant milestone for ARTMS, our partners and customers. The combination of these innovative technologies reflects Telix’s commitment to working in partnership to reach more patients with ⁶⁸Ga-PSMA-11, where and when they need it.”

The QIS® forms part of ARTMS’ “turnkey” solution for customers that encompasses in-house manufactured targets and chemistry processing of isotopes, as well as DMF preparation and filing support. This makes large scale isotope production for hospitals and radiopharmaceutical distributors with cyclotrons significantly more attainable than with other existing technologies.

ARTMS will continue to support the high efficiency, large-scale and cost-effective production of commercially important medical isotopes such as zirconium-89 (⁸⁹Zr), gallium-68 (⁶⁸Ga), technetium‐99m (^99mTc) and copper-64 (⁶⁴Cu), and will continue to partner with additional radiopharmaceutical companies to ensure that these critical isotopes are available on demand for patients. In addition, ARTMS’ portfolio of advanced cyclotron technologies has application for Telix and select partners in the production of future commercially important alpha-emitting, therapeutic isotopes, including actinium-225 (²²⁵Ac) and astatine-211 (²¹¹At).

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^[1] A DMF is a submission to FDA used to provide confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drug products.