ARTMS Products (Vancouver, B.C) has won the CE mark for its first-in-class, advanced technology Quantm irradiation system, designed to produce high-value medical imaging isotopes such as technetium-99m (Tc-99m) on medical cyclotrons.
Tc-99m is given to nearly 50,000 Americans every day to diagnose cancer and heart disease. It is used in more than 80% of all nuclear medicine imaging procedures globally, including those for oncology, urology and neurology. The light-emitting isotope is made by bombarding Molybendum-99 (moly-99) with neutrons. The temporary shutdown of two reactors that produced moly-99 led to a global shortage in 2009-10.
The only North American reactor that produced moly-99, in Chalk River, Ontario, produced 40% of the U.S. supply and closed in March. Others are located in Australia, Europe and South Africa. Because of the short half-life and value of moly-99, shipping is costly. SHINE Medical Technologies is developing a 57,000-square-foot medical isotope manufacturing plant in Janesville, Wisc.
ARTMS developed its Quantm irradiation system to make it possible for hospital-based and other medical cylotrons to produce Tc-99 and Ga-68 locally and reliably. Cyclotron facilities are constantly facing higher isotope costs and poor supply availability, according to a statement by the company. Quark Venture Inc. and GF Securities, through its Global Health Science Fund, raised $3 million (U.S.) in December, enabling ARTMS to set up operations as a stand-alone company and focus on partnerships, commercialization and production.
The technology was developed in collaboration with TRIUMF, Canada’s particle accelerator center and scientists at three health research institutes across Canada, including the British Columbia Cancer Agency, the Centre for Probe Development and Commercialization and Lawson Health Research. Early stage research funding was provided by the Canadian government through NSERC and the Isotope Technology Acceleration Program (ITAP Program).
“CE marking is an important milestone for ARTMS,” said Kaley Wilson, CEO of ARTMS and Quark Venture, in the statement. “There is a huge opportunity in providing a cost-effective and secured supply of radioisotopes to hospitals and research institutions. ARTMS provides a more economical, environmentally safe and secured supply of important radioisotopes than reactor-based sources. Now, with CE marking approval, ARTMS can be readily integrated in a standardized fashion into existing and emerging facilities which ultimately leads to improved patient access and care across Europe.”
ARTMS will also be developing the Quantm irradiation system to allow its partners and customers to produce other high-value isotopes such as gallium-68 (Ga-68), copper-64 (Cu-64) and zirconium-68 (Zr-89). ARTMS’ QUANTM system is available for most OEM cyclotron systems and has been installed and is operating in a number of countries. It has not received FDA approval.