MADISON, Wis., May 6, 2025 -- The Food and Drug Administration Agency (FDA) has updated the regulatory status of Marie®, Leo Cancer Care's upright particle therapy solution, to pending. Marie combines Leo Cancer Care's upright patient positioning system with their upright fan beam CT scanner and can be utilized with any fixed particle beam.
The submission is an important milestone bringing the technology one step closer to clinical use, in centers across the United States.
Stephen Towe, CEO of Leo Cancer Care shared these thoughts, 'Years of development go into changing an industry, but reaching the 510(k) pending milestone is always a wonderful celebration of everything that's been achieved over the last few years.
"This milestone marks the beginning of change for particle therapy, with the potential to take it to more patients who need it across the globe. Thanks to the relentless work of our team and partners, leading health networks are ready, and we eagerly await the FDA's decision."
What Scanning and Treating Upright Means for Treatment Delivery
The majority of radiotherapy treatments to date have been delivered with patients lying down with the radiation source rotated around them. Leo Cancer Care's solution challenges these conventions and will enable cancer patients to receive their radiation treatment seated in an upright position. The aim is to improve patient experience and comfort, increase clinical effectiveness and offer better access to radiotherapy.
Removing the need for large and expensive rotating gantries, the Leo solution utilizes a fixed radiation source and swaps machine rotation for patient rotation. With this innovation, we see particle therapy become typically one-third of the size, reducing the need for costly shielding, construction and technology, making particle therapy more accessible and affordable than ever before.
The system is positioned in the market as beam agnostic – meaning it can be placed in front of any fixed beam particle – and aims to make treatment modalities, including proton, carbon ion, neutron, and FLASH therapies, more mainstream.
Several centers that have adopted the technology across the United States eagerly await 510(k) clearance on this solution as they prepare their facilities for a planned first-in-the-world patient treatment later this year.
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