FDA clearance for P-Cure now includes full-body indications and supine treatment positions, significantly expanding clinical versatility and patient access
SHILAT, Israel, May 15, 2025 /PRNewswire-PRWeb/ -- P-Cure, a leader in compact proton therapy solutions, proudly announces that the U.S. Food and Drug Administration (FDA) has cleared the expanded intended use of its proton therapy system. This milestone approval now includes treatment of the full body and proton therapy delivery in the supine position, complementing the previously cleared indications for seated treatment and localized malignancies in the cranial, head and neck, and thoracic regions.
"This is a game-changer," said Dr. Michael Marash, Founder and CEO of P-Cure. "With this FDA clearance, we can now enable focused, high-precision treatment to any anatomical site and virtually any type of tumor eligible for radiotherapy—whether it's the brain vertex or the prostate. More importantly, this expansion supports the clinical flexibility to treat anesthetized pediatric patients in the widely accepted supine position and choose the optimal treatment posture for each case—seated or supine—based solely on the physician's judgment. This is the essence of our design philosophy: technology should adapt to the clinician, not the other way around. Now the FDA has endorsed this approach too."
The P-Cure system incorporates several innovations that make this clinical flexibility possible:
- Synchrotron-based Intensity Modulated Proton Therapy (IMPT) beam delivery, offering precise dose modulation and significantly lower levels of secondary neutron radiation.
- In-room diagnostic CT, enabling image-guided radiotherapy (IGRT) and adaptive treatment planning for evolving anatomy or tumor response.
- Robotic, multi-degree-of-freedom patient support, allowing comfortable and reproducible positioning in seated, supine, or hybrid orientations.
- Orthogonal X-ray imaging, integrated for motion tracking and compatible with industry-standard gating and motion management systems.
Beyond the clinical value, P-Cure's gantry-less architecture allows installation in linac-like vaults, reducing facility cost and footprint. This cost efficiency makes it possible for hospitals and regional centers to offer advanced proton therapy where it was previously unaffordable—delivering on P-Cure's mission to democratize access to precision oncology.
"We are incredibly proud of this milestone," said Ori Lubin, P-Cure's Head of Quality and Regulatory Affairs. "The process required meticulous planning, clinical justification, rigorous testing, and a relentless team effort. This clearance validates the system's performance across multiple treatment orientations and anatomical targets, with safety and clinical utility at the core."
About P-Cure:
P-Cure is redefining accessibility to proton therapy by offering compact, gantry-less systems capable of treating patients in multiple orientations with world-class imaging and beam delivery. By reducing cost, space, and complexity, P-Cure empowers more institutions to bring proton therapy closer to the communities that need it.
Media Contact
Stephen JACOBS, P-Cure, 1 9173468619, [email protected], p-cure.com
SOURCE P-Cure
Share this article