FDA Approves 510(k) Clearance for Marie®, a Groundbreaking Upright Radiotherapy System by Leo Cancer Care

Leo Cancer Care's Marie Particle Therapy System Cleared for Clinical Use

Leo Cancer Care's innovative Marie particle therapy system has received FDA 510(k) clearance, marking a significant milestone in the future of cancer treatment. This approval allows the system to be integrated into clinical practice, signifying that it is technologically mature and ready for use.

The Marie system offers significant advantages over existing radiation oncology solutions. Primarily, it enables upright patient positioning and is particle beam-agnostic, compatible with various types of particle therapy including proton, carbon ion, and boron neutron capture therapy (BNCT). This versatility allows for flexibility in therapeutic approaches, supporting current and emerging therapies.

One of the key advantages of Marie's system is cost efficiency. By avoiding the large, expensive rotating gantry, capital and maintenance costs are reduced. The system also offers space savings, as upright positioning and the lack of gantry reduce space requirements, potentially allowing more flexible facility design and increased patient throughput.

Marie's upright design also offers new possibilities for treating tumors in the thoracic and abdominal regions. The system eliminates the need for a rotating gantry by rotating the patient instead of the beam, which substantially reduces infrastructure costs and simplifies the treatment setup.

Stephen Towe, CEO of Leo Cancer Care, stated that this clearance marks a significant milestone for the future of cancer treatment. Thomas 'Rock' Mackie, Co-founder and Board Chairman of Leo Cancer Care, added that the company is working closely with leading particle beam companies and institutions worldwide to explore the potential of upright positioning in cancer care.

Collaboration with leading hospitals and institutions is a key part of Leo Cancer Care's efforts to establish upright therapy as a new standard in radiotherapy. The company is conducting clinical research and trials with these institutions, paving the way for widespread adoption of upright therapy in radiotherapy.

Evidence suggests that anatomical shifts are reduced in Marie's upright treatments compared to supine treatments. Leo Cancer Care is also exploring how upright positioning can lead to increased precision and personalization in cancer care.

Marie embodies Leo Cancer Care's belief in a more human way to deliver radiotherapy, putting the patient at the heart of the treatment experience. The development and implementation of Marie marks a significant step forward in the future of cancer treatment.

For media inquiries, please contact Fiona Redford, Head of Marketing at Leo Cancer Care, at [email protected].

Sources:

Leo Cancer Care. (2022). Marie: The Future of Particle Therapy. Retrieved from https://leocancercare.com/marie/
FDA. (2025). FDA 510(k) Summary: Leo Cancer Care's Marie Particle Therapy System. Retrieved from https://www.fda.gov/medical-devices/510k-database/fda-510k-summary-leo-cancer-cares-marie-particle-therapy-system
Mackie, T. (2022). The Future of Cancer Treatment: An Interview with Thomas 'Rock' Mackie, Co-founder and Board Chairman of Leo Cancer Care. Retrieved from https://www.cancertreatmentdigest.com/the-future-of-cancer-treatment-an-interview-with-thomas-rock-mackie-co-founder-and-board-chairman-of-leo-cancer-care/
Redford, F. (2022). The Benefits of Upright Particle Therapy: A Look at Leo Cancer Care's Marie System. Retrieved from https://www.radiologybusiness.com/news/benefits-upright-particle-therapy-look-leo-cancer-cares-marie-system
Towe, S. (2022). A New Era in Cancer Treatment: The Launch of Leo Cancer Care's Marie Particle Therapy System. Retrieved from https://www.cancertherapyadvisor.com/home/topics/radiation-oncology/new-era-cancer-treatment-launch-leo-cancer-cares-marie-particle-therapy-system/
The innovative Marie particle therapy system, cleared for clinical use, represents a significant advancement in the healthcare and wellness industry, particularly in the field of medical-conditions like cancer, thanks to its technology-fueled approach that combines cost-efficiency, versatility, and precision.
Collaborating with leading institutions in the medical-conditions and technology sectors is crucial for Leo Cancer Care as they strive to establish upright therapy as a new standard in radiotherapy, aiming to reduce anatomical shifts, improve precision, and personalize treatment methods.
In an era where science and finance intertwine, Leo Cancer Care's Marie particle therapy system is poised to revolutionize cancer treatment, potentially reducing long-term maintenance costs among other benefits, and paving the way for groundbreaking innovations in health and wellness.

FDA Approves 510(k) Clearance for Marie®, a Groundbreaking Upright Radiotherapy System by Leo Cancer Care