SAN FRANCISCO--(BUSINESS WIRE)-- AMERICAN SHARED HOSPITAL SERVICES (AMEX:AMS), a leading provider of turnkey technology solutions for advanced radiosurgical and radiation therapy services, today shared a recent announcement from Mevion Medical Systems, Inc., formerly Still River Systems, Inc., regarding Mevion Medical Systems Receipt of CE Marking Certification for its MEVION S250 Proton Therapy System. AMS owns approximately 1% of Mevion. AMS is developing proton therapy centers in Boston, Orlando and Long Beach, California, which are expected to employ the MEVION S250 proton therapy device. The MEVION S250 is currently pending FDA 510(k).
Mevion Medical Systems Receives CE Marking Certification
for the MEVION S250 Proton Therapy System
LITTLETON, MA, Mar. 14, 2012 -- Mevion Medical Systems, a radiation therapy company dedicated to advancing the treatment of cancer, has announced today that it has received CE Marking 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, Chief Executive Officer. 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 Washington University in St. Louis Missouri 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.
ABOUT MEVION MEDICAL SYSTEMS
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.
Founded in 2004, Mevion is a privately held company headquartered in the Boston metropolitan area with international offices in the United Kingdom and Japan.
The MEVION S250 Proton Therapy System is pending United States Food and Drug Administration 510(k) clearance.
Visit us at: www.mevion.com
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Melanie M. Miller
Marketing & Communications Coordinator
Mevion Medical Systems
E: mel[email protected]
American Shared Hospital Services provides turnkey technology solutions for advanced radiosurgical and radiation therapy services. AMS is the world leader in providing Gamma Knife radiosurgery equipment, a non-invasive treatment for malignant and benign brain tumors, vascular malformations and trigeminal neuralgia (facial pain). The Company also offers the latest IGRT and IMRT systems, as well as its proprietary Operating Room for the 21st Century® concept. Through its preferred stock investment in Mevion Medical Systems, Inc., formerly Still River Systems, AMS also plans to complement these services with the MEVION S250 proton beam radiation therapy (PBRT) system, which has not yet been approved by the FDA.
Safe Harbor Statement
This press release may be deemed to contain certain forward-looking statements with respect to the financial condition, results of operations and future plans of American Shared Hospital Services, which involve risks and uncertainties including, but not limited to, the risks of the Gamma Knife and radiation therapy businesses, the risks of developing The Operating Room for the 21st Century program, and the risks of investing in a development-stage company, Mevion Medical Systems, Inc., without a proven product. Further information on potential factors that could affect the financial condition, results of operations and future plans of American Shared Hospital Services is included in the filings of the Company with the Securities and Exchange Commission, including the Company's Annual Report on Form 10-K for the year ended December 31, 2010, the Quarterly Report on Form 10-Q for the quarter ended March 31, 2011, Form 10-Q and 10-Q/A for the quarter ended June 30, 2011, and Form 10-Q for the quarter ended September 30, 2011, and the definitive Proxy Statement for the Annual Meeting of Shareholders held on June 9, 2011.
American Shared Hospital Services
Ernest A. Bates, M.D., 415-788-5300
Chairman and Chief Executive Officer
Neil Berkman, 310-826-5051
KEYWORDS: United States North America California Massachusetts
INDUSTRY KEYWORDS: Surgery Health Biotechnology Hospitals Medical Devices Oncology Radiology