ARTMS Inc. Submits Drug Master File for the First Ever Multi-Curie Production of Gallium-68 with ARTMS’ Solid Target Solution on Medical Cyclotrons

“This submission to the FDA demonstrates how the team at ARTMS is executing our strategy. The molecular imaging community has and will continue to develop a number of innovative agents that are labeled with ⁶⁸Ga. Unfortunately, the current supply chain of germanium/gallium generators is not robust enough to meet projected demand for these products. The action taken today by ARTMS marks a significant step toward solving the forthcoming supply issues for this critical isotope. ARTMS has spent the last 18 months solidifying partnerships with drug developers and building a network of cyclotron operators with the intention of changing the way isotopes are delivered to patients in greatest need of these imaging studies. The ARTMS platform goes far beyond ⁶⁸Ga production, expanding our client’s reach to other high demand diagnostic and therapeutic isotopes. I am extremely excited about the opportunity that is in front of ARTMS and our partners,” says Charles S. Conroy, Chief Executive Officer of ARTMS.

The use of ⁶⁸Ga labelled products is among the most important innovations in the history of nuclear medicine. Currently, ⁶⁸Ga radiopharmaceuticals are used to identify and stage a variety of oncology conditions, including neuroendocrine tumors and prostate cancer. This isotope has been traditionally supplied by generators which have limited output capabilities and are logistically and economically burdensome. While generators will continue to be a part of the ⁶⁸Ga supply chain, ARTMS’ technology will alleviate widespread shortages as demand increases for ⁶⁸Ga labelled diagnostic agents.

“It is our strategy to work alongside the radiopharmaceutical innovator community to allow the ARTMS solution and associated regulatory filings to be included in the innovator’s investigational new drug and new drug applications,” said Dr. Michael Cross, Chief Operating Officer and project lead at ARTMS. “Moving forward, ARTMS will continue to expand collaboration efforts with the radiopharmaceutical innovators to validate ARTMS’ ⁶⁸Ga with these important medical products.”

With a focus on optimizing production potential, ARTMS will continue the development of cyclotron-produced ⁶⁸Ga and other vitally important medical isotopes, while also pursuing multiple regulatory approvals. ARTMS has a variety of solid targets commercially available used in combination with ARTMS’ QUANTM Irradiation System (QIS™).

About ARTMS

Based in Vancouver, British Columbia, Canada, ARTMS Inc. is a global leader in the development of novel technologies and products which enable the high-quality and high-yield production of the world’s most-used diagnostic imaging isotopes. ARTMS’ flagship product, the QUANTM Irradiation System^TM (QIS^TM), enables decentralized, cost-effective, large-scale production of important medical isotopes such as gallium-68 (⁶⁸Ga), zirconium-89 (⁸⁹Zr), technetium‐99m (^99mTc) and copper-64 (⁶⁴Cu) using pharmaceutical distributor and hospital-based medical cyclotrons, empowering users to control their supply chain. ARTMS commercializes these award-winning and proprietary Canadian inventions on a global basis and has the prospect of revolutionizing the nuclear medicine industry.

For more information on the QUANTM Irradiation System™ and ARTMS, please follow us on Twitter @Quantm99 and LinkedIn and visit http://www.artms.ca/

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