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.
"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 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™, 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
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.