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SRI spin-off company, Arrayus, announces Health Canada approval of its focused ultrasound therapy system

October 7, 2024

Arrayus Technologies Inc., a Sunnybrook Research Institute (SRI) spin-off company, is pleased to announce that its MRI-guided focused ultrasound (FUS) system has been granted approval by Health Canada for the ablation of uterine fibroid tissue. Following the success of its first-in-human clinical trial, this approval paves the way for Canadian health-care providers to offer a safe, non-invasive alternative to traditional surgical options for this common gynecological condition.

Arrayus' FUS system, offers a transformative approach to non-invasive therapy, using high-precision acoustic energy to target and treat tissue deep within the body without the need for incisions or general anesthesia. Built with the world's first clinically-available fully phased array, intuitive treatment planning tools and real-time therapy monitoring, the system enables clinicians to tailor treatments based on individual disease characteristics, ensuring precision while protecting nearby healthy tissue.

“The approval of this FUS system will play a necessary role in transforming patient care and outcomes for uterine fibroids,” says Dr. Kullervo Hynynen, founder of Arrayus and vice-president of research and innovation at Sunnybrook. Dr. Hynynen is a global pioneer in FUS research, and was the first to combine FUS with MRI to guide and monitor treatment. “The potential for FUS has continued to expand, developing innovative and minimally invasive ways to treat some of the world’s most debilitating diseases.”

Arrayus is actively expanding the potential applications for its focused ultrasound platform. The company has clinical trials underway to evaluate the use of its system in various oncological settings, and is working with health-care professionals, researchers, and industry partners to explore its use in neurology, women's health, and beyond.

“Uterine fibroids are very common, and in some cases, can adversely impact a woman’s quality of life,” explains Dr. Elizabeth David, an affiliate scientist and interventional radiologist at Sunnybrook, who is also the principal investigator of the clinical trial. “This FUS system has the potential to revolutionize women’s health by providing a precise and non-invasive alternative for treating uterine fibroids.”

Read the original press release from Arrayus Technologies Inc. for more information.