New Generation Accelerator by IBA receives FDA clearance authorization

Proton therapy

Proteus®ONE is the world's only FDA cleared and CE marked compact solution using image guided IMPT – now available for US patients

Louvain-La-Neuve, Belgium, August 18, 2016 – IBA (Ion Beam Applications SA), the world’s leading provider of proton therapy solutions for the treatment of cancer, has received FDA clearance for its new super conducting accelerator. The accelerator is the latest development, essential to the Pro-teus®ONE*, IBA’s compact Intensity Modulated Proton Therapy (IMPT) solution, that required approval from regulatory authorities.

The FDA clearance makes Proteus®ONE, the only compact proton therapy solution in the industry, that is certified to treat patients in the US with optimized Pencil Beam Scanning (PBS) and image guidance.

IBA has already signed 13 contracts to provide its compact proton therapy solution, Proteus®ONE,
worldwide. The recent FDA clearance is an important milestone that will ensure on time delivery of all of IBA’s current and future contracts and underscores the fact that for compact proton therapy, IBA has the fastest delivery and installation times in the world.

Beth Klein, President of IBA Proton Therapy North America, shared: “FDA clearance of our Proteus®ONE's new super conducting accelerator will be a significant market accelerator for proton therapy in the United States, because Proteus®ONE provides the most advanced treatment mode (IMPT) within the most compact and affordable system. Any hospital considering Proton therapy can now afford it through the Proteus One’s lower capital and operating costs without making any
clinical compromise. Ultimately, this will make proton therapy more accessible to the radiation therapy patients in the United States who can benefit from it.

Gregory Saive, Proteus®ONE Product Manager, commented on the achievement: "IBA continues to demonstrate its leadership in proton therapy. No other company has been able to obtain certifications from major authorities like the CE marking bodies and the FDA within five months. While other vendors work on their old, existing platforms to develop single room systems, we have decided to design a truly compact solution optimized for IMPT. This unique design associated with our
certifications makes the Proteus®ONE a unique solution that is unrivaled in the market.”

The Proteus®ONE is the world’s only FDA cleared and CE marked compact solution that uses image guided IMPT. With IBA’s industrialized production together with a complete CE approval and FDA clearance, IBA is now able to install complete proton therapy system in less than twelve months.

About Proteus®ONE

Proteus®ONE solution comprises the latest technologies in proton therapy, making it the ideal platform for Research and Development purposes. Proteus®ONE solution is smaller, more affordable, easier to install and operate and is ultimately easier to finance than most common solutions. All these attributes make our proton therapy solutions accessible to more and more Healthcare Institutions worldwide.
Proteus®ONE is equipped with Pencil Beam Scanning, a technology that offers high sub-millimeter pre-cision treatment, which allows delivery of very high levels of conformity and dose uniformity, even in complex-shaped tumors, whilst at the same time sparing the surrounding healthy tissue.

*Proteus®ONE is the brand name of a new configuration of the Proteus® 235.


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