Arrayus Technologies has announced the Health Canada approval for its magnetic resonance imaging (MRI)-guided focused ultrasound therapy system for uterine fibroid tissue ablation.
The approval follows the successful completion of a first-in-human clinical trial, offering healthcare providers in Canada a non-invasive treatment alternative for the gynaecological issue.
It uses high-precision acoustic energy to target and treat tissue deep within the body without incisions or the need for general anaesthesia.
The system is said to be equipped with the world's first clinically available fully phased array. It also features treatment planning tools and real-time therapy monitoring.
This allows clinicians to customise treatments to individual patient needs, ensuring accuracy and the safety of surrounding healthy tissue.
Arrayus CEO James O'Reilly said: “I am incredibly proud of our team for achieving this monumental first milestone.
“Securing Health Canada approval marks a pivotal moment in the evolution of our technology but it's only the beginning. Our platform has the potential to transform patient care across multiple medical specialities.
“We are committed to pushing the boundaries of medical innovation to reduce the burden on the healthcare system and improve patient outcomes worldwide.”
Arrayus is actively pursuing the expansion of its focused ultrasound platform. Clinical trials are currently in progress to assess the system in various oncological treatments.
The company is collaborating with healthcare professionals, researchers, and industry partners to investigate potential applications in neurology and women's health, among other areas.
To facilitate the commercialisation and further development of its platform, Arrayus is seeking its first institutional funding round.
The company specialises in the development, manufacturing, and commercialisation of focused ultrasound technology, particularly for oncological applications.