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American Shared Hospital Services Shares News That Mevion Medical Systems Has Received FDA 510(k) Clearance for Its MEVION S250 Proton Therapy System

Mon, 06/11/2012 - 9:45am
The Associated Press

SAN FRANCISCO--(BUSINESS WIRE)--Jun 11, 2012-- 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.

regarding Mevion Medical Systems' receipt of FDA 510(k) clearance for its MEVION S250 Proton Therapy System.

"The Mevion team has created a truly revolutionary medical therapy device. Revolutionary in the sense that this machine combines the elements of a superconducting synchrocyclotron mounted on a gantry that is less expensive than all other proton therapy devices, using accelerator technology that has been proven to be reliable and simple for the user," said AMS Chairman and Chief Executive Officer Ernest A.

Bates, M.D.

"This is an exciting day for Mevion, for AMS, and for cancer patients and clinicians worldwide. The MEVION S250 significantly reduces the cost, size and complexity of proton technology, and promises to bring accessibility, affordability and practicality to this innovative therapy. With FDA 510(k) clearance for the MEVION S250 now in hand, we expect AMS' proton therapy business to accelerate, both the projects we have already announced as well as additional projects that have awaited the FDA's positive decision," said Craig K. Tagawa, Chief Operating Officer of AMS.

AMS owns approximately 1% of Mevion, and is developing proton therapy centers in Orlando, Boston and Long Beach, California which are expected to employ the MEVION S250 proton therapy device: Mevion Medical Systems Announces FDA 510(k) Clearance for the MEVION S250 Proton Therapy System MEVION S250 patented technology significantly reduces the cost of implementing and operating proton therapy centers.

LITTLETON, MA., June 11, 2012 -- Mevion Medical Systems, Inc., a radiation therapy company dedicated to advancing the treatment of cancer, announced today that it has received FDA 510(k) clearance for its MEVION S250 Proton Therapy System. The MEVION S250 is a first-of-its-kind proton/therapy system that provides the same precise, non-invasive treatment advantages and capabilities of complex, large, and costly proton therapy systems but with higher patient throughput, a significantly reduced footprint, improved reliability, and lower implementation and operational costs. The MEVION S250 delivers precise and intense proton beams that physicians can use to treat tumors and lesions or any other condition where radiotherapy is indicated.

The broad adoption of proton therapy has been greatly limited by the enormous cost, large footprint, and technical complexity of traditional proton therapy systems. Powered by a patented TriNiobium Core(TM), the MEVION S250 proton therapy system redefines the economics, availability, and the future direction of proton therapy, by bringing the management and operation of proton therapy to levels similar to modern X-ray radiation therapy devices. "Completing this very important milestone is a testament to the maturity of the Mevion organization and its ability to manufacture, install and support a safe and effective product," said Joseph Jachinowski, Chief Executive Officer of Mevion Medical Systems. "We are pleased to receive this clearance from the FDA and now look forward to providing our customers and their patients access to this revolutionary device." This clearance enables users of the MEVION S250 to immediately treat patients upon completion of their system installation. The first installation of the MEVION S250 will soon be completed at the Kling Center for Proton Therapy at Barnes Jewish Hospital at Washington University in St. Louis, Missouri.

Mevion will be delivering and installing more than a dozen MEVION S250 proton therapy systems worldwide within the next two years, making it one of the leading providers of proton therapy systems. MEVION S250 installations are also underway at Robert Wood Johnson University Hospital in New Jersey and Oklahoma University in Oklahoma. Additional sites in Florida and California will follow these installations.

Earlier this year, the MEVION S250 received CE certification, which gives Mevion the ability to market, sell, import, and install proton therapy systems in the European Union and other regions where the CE Marking is recognized.

About Mevion Medical Systems Mevion Medical Systems, Inc. is a radiation therapy company dedicated to advancing the treatment of cancer. As the pioneering developer of 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.

Visit us at: www.mevion.com About AMS 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(R) concept.

Through its preferred stock investment in Mevion Medical Systems, Inc., AMS also plans to complement these services with the MEVION S250 proton beam radiation therapy (PBRT) system.

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 and Proton Beam Radiation Therapy programs, 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, 2011, the Quarterly Report on Form 10-Q for the quarter ended March 31, 2012, and the definitive Proxy Statement for the Annual Meeting of Shareholders held on June 7, 2012.

CONTACT: American Shared Hospital Services Ernest A. Bates, M.D., (415) 788-5300 Chairman and Chief Executive Officer e.bates@ashs.com or Berkman Associates Neil Berkman, (310) 826-5051 President info@berkmanassociates.com KEYWORD: UNITED STATES NORTH AMERICA CALIFORNIA MASSACHUSETTS INDUSTRY KEYWORD: SURGERY HEALTH MEDICAL DEVICES ONCOLOGY RADIOLOGY FDA SOURCE: American Shared Hospital Services Copyright Business Wire 2012 PUB: 06/11/2012 12:46 PM/DISC: 06/11/2012 12:46 PM http://www.businesswire.com/news/home/20120611006216/

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