March 14, 2012 - Mevion Medical Systems announced today it received CE mark certification for the Mevion S250 Proton Therapy System. This important commercial milestone indicates that Mevion has completed its development in compliance with the European Union's Medical Device Directive. The CE Marking allows the MEVION S250 to be marketed, sold, and installed in the European
Union and in any country recognizing CE mark approval.
Proton beam radiotherapy can accurately deliver targeted radiation doses with complete proton energy absorption at predictable tissue depth, thus allowing precise radiation delivery adjacent to critical structures and lower radiation doses to healthy structures. The availability of proton therapy has remained very limited however, due to the enormous cost, large footprint and technical complexity of traditional proton therapy systems.
CE Marking of the MEVION S250 gives hospitals and cancer treatment centers throughout the European Union, and other regions where CE Marking is recognized, the ability to order, install, and treat patients with this revolutionary medical device. Powered by a TriNiobium CoreTM, the MEVION S250 significantly reduces the cost, size and complexity of proton therapy systems to levels similar to modern X-ray radiation therapy devices and brings accessibility, affordability and practicality to proton therapy.
"We are very pleased to receive CE Marking certification for the MEVION S250, the final step to offer this first of its kind proton therapy system to healthcare providers and patients in the European Union," said Joseph K. Jachinowski, CEO.
In the United States, the MEVION S250 is pending USFDA 510(k) clearance.
Mevion is concurrently installing three MEVION S250 Proton Therapy Systems in the United States. The first site at the Siteman Cancer Center in Barnes Jewish Hospital at St. Louis' Washington University accepted delivery of its superconducting synchrocyclotron in October of 2011 and is now producing a powerful 250 MeV energy beam. The second and third installations at Robert Wood Johnson
University Hospital in New Brunswick, NJ and Oklahoma University, OK are underway and scheduled to be completed later this year.
American Shared Medical Services, a provider of turnkey technology solutions for advanced radiosurgical and radiation therapy services, owns about 1 percent of Mevion. AMS is developing proton therapy centers in Boston, Orlando, Fla. and Long Beach, Calif., which are expected to employ the MEVION S250 proton therapy device. The MEVION S250 is currently pending FDA 510(k) review.
Mevion Medical Systems Inc. (formerly Still River Systems Inc.) is a radiation therapy company dedicated to advancing the treatment of cancer. As the pioneering developer of modern proton therapy systems, Mevion provides innovative, safe, and effective solutions by transforming advances in medical technology and science into practical clinical reality.
Mevion's flagship product, the MEVION S250 Proton Therapy System, is designed to preserve all of the treatment benefits of traditional proton therapy systems while removing the obstacles of size, cost, and complexity. Realizing this vision, Mevion has forever changed the economics and accessibility of proton therapy worldwide.
For more information: www.mevion.com