#USA #FDA Clearance #Middleton #Leo Cancer Care #Marie Platform

Leo Cancer Care Achieves FDA 510(k) Clearance for Marie®

In a groundbreaking development for cancer treatment, Leo Cancer Care has announced that its innovative product, Marie®, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). This milestone marks a significant shift in the landscape of radiotherapy, providing a new avenue for patient care and treatment methodologies.

Marie® represents a pioneering upright radiotherapy platform that redefines how particle therapy is delivered. By integrating a unique patient positioning system with an advanced CT scanner, Marie aims to enhance the overall experience for patients and healthcare practitioners alike. One of the standout features of this system is its ability to reduce costs and the physical footprint associated with traditional particle therapy solutions, which has often hindered their widespread adoption.

Stephen Towe, CEO of Leo Cancer Care, emphasized, "This clearance marks a major milestone not just for Leo Cancer Care, but for the future of cancer treatment. 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."

Traditionally, particle therapies such as proton and carbon ion therapies have been regarded as top-tier options in radiation oncology. However, these treatments come with considerable costs and complex setups, particularly due to the large rotating gantries required by most systems. Marie addresses these issues by rotating the patient instead of the radiation beam. This innovative approach significantly lowers infrastructure costs, simplifies the installation process, and broadens access to this advanced form of care.

Moreover, Marie is designed to be particle beam-agnostic, accommodating a wide range of both current and future treatment modalities, including proton therapy, carbon ion therapy, BNCT (Boron Neutron Capture Therapy), and FLASH therapies. By enabling an upright treatment position, it also opens new avenues for more efficient treatment planning, particularly for tumors located in the thoracic and abdominal regions. Studies suggest that this upright design can reduce anatomical shifts caused by gravity, enhancing treatment precision compared to traditional supine therapies.

In collaboration with top medical institutions globally, Leo Cancer Care is actively conducting clinical research and trials to establish a solid foundation for the widespread adoption of upright therapy as the new standard in radiotherapy. This collaborative effort not only aims to validate the efficacy of the Marie platform but also to push the boundaries of patient-centric care in oncology.

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

As Leo Cancer Care continues to innovate and lead in the field of upright radiotherapy, the implications of Marie's FDA clearance are overarching, promising to facilitate a future where cancer treatment is more accessible, efficient, and aligned with patients' needs.



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