IBA (Ion Beam Applications SA), the world's leading provider of proton therapy solutions for the treatment of cancer, announces that it has received Marketing Authorization from the U.S. Food and Drug Administration (FDA) for its Compact Gantry Beam Line (CGBL: FDA 510(k) K132919). IBA anticipates that this regulatory approval will intensify the international interest in Proteus®ONE*, IBA's next generation proton therapy compact system.
Proteus®ONE is IBA's single-room proton therapy system which is smaller, less expensive, faster to install and encompasses the latest in targeted proton therapy technologies, including IBA's Intensity Modulated Proton Therapy (IMPT). IBA created the Proteus®ONE system to allow more patients access to proton therapy globally and has already sold five Proteus®ONE systems in Shreveport, Louisiana (USA), Nice (France), Taiwan (China) and two in Japan.
Olivier Legrain, Chief Executive Officer of IBA commented: "We are delighted to have received Marketing Authorization from the FDA for the Proteus®ONE Compact Gantry. This is an exciting milestone for our customers in North America, where the cost of healthcare is a major focus. The Proteus®ONE aligns with the US healthcare trend of providing the highest quality of cancer treatment possible at the best possible price. We are confident that Proteus®ONE will drive greater momentum in the adoption of this next generation targeted cancer treatment internationally. The approval reaffirms our world leading position in the delivery of highly targeted, safer cancer treatment solutions. We very much look forward to the first patients at the Willis-Knighton Cancer Centre in the US benefitting from our compact proton therapy offering later this year."
Lane R. Rosen, MD, Director of Radiation Oncology at the Willis-Knighton Cancer Centre, added: "We are very excited to have Intensity Modulated Proton Therapy become an available option for our patients. The complete clearance of the Proteus®ONE system, installed at Willis-Knighton, is yet another milestone demonstrating how IBA and WKCC partner for progress."