Latest news with #LeoCancerCare
Korea Herald
29-07-2025
- Health
- Korea Herald
Leo Cancer Care Receives FDA 510(k) Clearance for Marie® - A Revolutionary Upright Radiotherapy Platform
MIDDLETON, Wis., July 29, 2025 /PRNewswire/ -- Leo Cancer Care, a leader in upright radiotherapy solutions, today announces that its flagship product, Marie®, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). 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. "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." Particle therapies such as proton and carbon ion therapy have long been considered the gold standard in radiation oncology. However, the cost, size, and complexity of conventional systems with large rotating gantries have historically limited widespread adoption. Leo Cancer Care's upright solution addresses these barriers. By rotating the patient rather than the beam, Marie eliminates the need for a rotating gantry, dramatically reducing infrastructure costs, simplifying installation, and expanding access to this advanced level of care. 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."
Yahoo
06-05-2025
- Health
- Yahoo
Leo Cancer Care Particle Therapy Solution Marie is now 510(k) Pending
MADISON, Wis., May 6, 2025 /PRNewswire/ -- 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. Marie, Leo Cancer Care's Upright Particle Therapy Solution 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. Photo: Cision View original content to download multimedia: SOURCE Leo Cancer Care
