Regulatory Clearance for Marie®, Leo’s upright radiotherapy platform

We are delighted to share the news that Leo Cancer Care has gained regulatory 510(k) clearance for Marie®, its revolutionary upright patient radiotherapy treatment system.

Marie® represents a paradigm shift in the delivery of particle therapy, combining an upright patient positioning system and a CT scanner that reimagines the treatment experience for both patients and clinicians, whilst drastically reducing the size and cost compared to existing particle therapy solutions. Marie® enables cancer patients to receive radiation treatment seated in an upright position. Research has shown that the approach is a more natural position for patients, with evidence suggesting that this will contribute to less internal organ movement, leading to more efficient delivery of radiotherapy. Studies have also shown that patients prefer to be in the upright position, rather than lying down.

“This clearance marks a major milestone not just for Leo Cancer Care, but for the future of cancer treatment,” said Stephen Towe, CEO of Leo Cancer Care. “We’ve long believed there’s a better, more human way to deliver radiotherapy. One that puts the patient at the heart of the treatment experience and embraces smarter, more compassionate design. Marie is the embodiment of that belief.”

Marie is particle beam-agnostic, meaning it’s compatible with a wide range of current and emerging treatment modalities, including proton, carbon ion, BNCT and FLASH therapies. Its upright design opens new possibilities for treatment planning and delivery, particularly for tumors in the thoracic and abdominal regions. When compared to supine treatments, evidence suggests anatomical shifts are reduced due to the gravitational direction.

Through collaborations with leading hospitals around the world, Leo Cancer Care is conducting clinical research and trials, laying a strong foundation for the widespread adoption of upright therapy as a new standard in radiotherapy.

“We are incredibly proud of the teams and collaborators who helped bring Marie to life,” added Thomas ‘Rock’ Mackie, Co-founder and Board Chairman of Leo Cancer Care. “This is just the beginning. We’re working closely with leading particle beam companies and institutions worldwide to explore how upright positioning can unlock new levels of precision and personalization in cancer care.”

DCA is hugely proud to have supported Leo Cancer Care in the design of the ‘Marie®‘ upright patient radiotherapy treatment system, as well as their ‘Eve®’ and ‘Ruby’ all part of Leo’s drive for revolutionary advancements in patient positioning for radiotherapy treatment.

Robert Woolston, DCA’s Managing Director commented “Congratulations to Leo Cancer Care in gaining this 510(k) clearance; another great step forward in the fight against cancer.“

Find out more about our work with Leo Cancer Care using the links below.

Congratulations to the Leo Cancer Care team, read their news item with this link.