FDA Clears Provision Healthcare’s ProNova SC360 Proton Therapy System

Provision Healthcare’s research, development and manufacturing subsidiary, ProNova Solutions, has received FDA 510(k) clearance for its SC360 proton therapy system only four years after commencing research and development. This is the first and only compact 360 degree pencil beam scanning proton therapy system capable of treating patients at all angles without moving the patient, enabling the most efficient clinical workflows, improved accuracy of treatment, and patient comfort.
 
The first ProNova system is expected to be used for patient treatment at the Provision CARES Proton Therapy Center in Knoxville, Tenn. next year.
 
Provision Healthcare launched ProNova in 2012 to develop a more technologically advanced proton therapy treatment system. Leveraging its founders’ experience in the development and global commercialization of PET and PET/CT technology, ProNova utilizes proprietary, superconducting technology to build compact proton therapy systems with greater value than competing systems. The ProNova SC360 is the only proton therapy system developed in a clinical setting, benefitting from continuous input from physicians, medical physicists, and therapists during the entire course of design and development. The system includes state-of-the-art features such as pencil beam scanning and advanced imaging with cone-beam CT, all in a compact design.
 
“Achieving this milestone is an enormous accomplishment for our company and will allow us to offer the most advanced technology without compromising features for proton therapy treatment through systems that are smaller, lighter and easier to install while increasing capabilities compared to our competitors,” said Joe Matteo, President of ProNova Solutions. “The ProNova SC360 will not only improve proton therapy treatment, but due to its lower cost, will make proton therapy more accessible to patients worldwide.”
 
“Provision Healthcare provides innovative healthcare solutions that CARES for the patient as we offer the ProNova system in developing proton therapy centers around the world,” said Terry Douglass, Executive Chairman of Provision Healthcare. Provision Solutions is the exclusive distributor of the ProNova system and has multiple agreements for development of proton therapy centers utilizing the ProNova Solutions systems in the United States, Europe and Asia.