FDA Greenlights Marie, a Gantry-Free Upright Radiotherapy Platform

The FDA has cleared Marie, an upright radiotherapy platform from Leo Cancer Care. Marie can work with various types of particle therapies, such as proton therapy, carbon ion therapy, boron neutron capture therapy (BNCT) and FLASH therapy.

Particle therapy uses protons or other charged particles rather than X-ray radiation. These particles release most of their energy at the tumor site and then stop, which limits exposure to nearby healthy tissue. This method has gained interest in both hospital-based treatment and clinical research.

Particle therapy is particularly helpful near sensitive organs or in reducing long-term side effects in pediatric cancers. It is also being used or studied for head and neck, spinal, prostate, lung and liver cancers, where high precision is essential.

As an upright radiotherapy platform, Marie positions patients seated or standing for treatment. It also includes a built-in CT scanner, allowing for imaging and planning in the same position used during therapy, which helps improve consistency across sessions.

Instead of rotating the beam, Marie rotates the patient. This eliminates the need for large gantry systems, simplifying the setup.

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Traditional gantries used in proton therapy can weigh over 200 tons and span several stories, which adds to the high cost and complexity of treatment rooms. Gantry-less systems typically weigh under 3 tons and require shielding in only one direction. This can cut construction costs by more than half and allows for easier installation in existing hospital spaces.

These systems are becoming popular worldwide, especially in proton therapy centers. While most clinical experience has focused on tumors of the head and neck, several centers are starting to explore upright treatment for thoracic and pelvic cancers. Studies indicate that upright positioning can increase lung volume and reduce breathing motion, which may impact future treatment planning.

Marie works with various existing and emerging particle therapy methods. Its upright design may be particularly beneficial for treating tumors in the thoracic and abdominal areas, where gravity helps to minimize anatomical shifts during treatment.

Upright radiotherapy systems are entering a growing global market for external beam radiation devices, which accounted for over 70% of the radiotherapy device market in 2023. That market was valued at $5.68 billion and is expected to reach $13.38 billion by 2033. Growth is driven by rising demand for proton therapy and better access to cancer care.

Leo Cancer Care has ongoing collaborations with hospitals to support clinical research and trials using the Marie platform. The FDA clearance allows the company to expand upright particle therapy in the US.

What Is the Particle Therapy Market Like?

Several major companies are involved in the particle therapy field, including Siemens Healthineers (Varian), Hitachi, IBA Worldwide, Mevion Medical Systems and Sumitomo Heavy Industries. These companies are developing systems for different therapy types and setups, ranging from traditional multi-room setups to newer compact and single-room designs.

Cyclotrons, which generate the particle beams used in therapy, are also gaining attention for their dual use in treatment and imaging, with companies like IBA and GE Healthcare offering cyclotron systems.

Emerging innovators include B dot Medical Inc. and Advanced Oncotherapy, both of which are working on next-gen delivery platforms.

Recent advancements include the introduction of MRI-guided proton therapy systems and more heavy-ion therapy installations across Asia.

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