FDA Reviews Leo Cancer Care’s Upright Particle Therapy Solution, Marie®

The Food and Drug Administration (FDA) has recently updated the regulatory status of Marie®, an innovative upright particle therapy solution developed by Leo Cancer Care, to pending. This marks a significant step towards making the technology available for clinical use in the United States. Marie® represents a unique combination of Leo Cancer Care’s upright patient positioning system and an upright fan beam CT scanner, designed to work with any fixed particle beam. Achieving the 510(k) pending milestone is a critical moment in the ongoing effort to advance particle therapy for cancer treatment.

Stephen Towe, CEO of Leo Cancer Care, expressed his enthusiasm regarding the FDA update, emphasizing that years of development are required to transform the industry. Reaching this regulatory stage is seen as a culmination of the hard work put in by the Leo Cancer Care team and their partners. Towe highlighted that this progress signals the beginning of a new phase in particle therapy, with the potential to make the treatment more widely accessible to patients in need. He credited the relentless efforts of the development team for bringing the technology closer to real-world application, as many leading health networks stand prepared to implement the solution pending FDA approval.

Traditionally, radiotherapy treatments involve positioning patients in a supine (lying down) position while the radiation source rotates around them. In contrast, Leo Cancer Care’s approach reimagines this process by positioning patients in a seated, upright position during treatment. This method not only enhances patient comfort but also aims to improve clinical effectiveness and accessibility. By removing the need for large, rotating gantries, the Marie® system significantly reduces the size and cost of particle therapy setups. Instead of rotating the radiation machine, the upright system rotates the patient, allowing the use of a fixed radiation source. As a result, the particle therapy setup becomes about one-third the size of conventional systems, lowering expenses related to shielding, construction, and technology.

This streamlined, upright approach to therapy is designed to make advanced treatments, such as proton, carbon ion, neutron, and FLASH therapies, more common and accessible. Since the system is beam agnostic, it can be placed in front of any fixed beam particle source, offering versatility and compatibility with various treatment modalities. This practical and economic innovation has the potential to revolutionize the way radiotherapy is delivered, reducing the physical and financial barriers that often limit access to advanced cancer care.

The technology is generating significant anticipation among several healthcare centers across the United States. These institutions are actively preparing their facilities in hopes of becoming the first in the world to treat a patient using Marie® later this year, contingent on receiving final FDA clearance. The excitement reflects the broader impact that such an innovation could have on global cancer care, making sophisticated particle therapy treatments more efficient, affordable, and patient-friendly.

Leo Cancer Care’s efforts to innovate within the field of radiotherapy exemplify a commitment to improving patient outcomes while reducing healthcare costs. By advocating for a patient-centric approach that prioritizes comfort and effectiveness, Marie® could reshape the standard of care for many types of cancer. As the FDA reviews this promising technology, the medical community and patients alike remain hopeful that it will soon be integrated into clinical practice, setting a new benchmark for modern particle therapy.