23.04.2015
Eckert & Ziegler Strahlen- und Medizintechnik AG DE0005659700
DGAP-News: Eckert & Ziegler's SagiNova(R) afterloader receives FDA market clearance
DGAP-News: Eckert & Ziegler Strahlen- und Medizintechnik AG / Key
word(s): Regulatory Approval
Eckert & Ziegler's SagiNova(R) afterloader receives FDA market
clearance
23.04.2015 / 07:45
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Press release
Eckert & Ziegler's SagiNova(R) afterloader receives FDA market clearance
Berlin, April 23, 2015. Eckert & Ziegler has received market clearance from
the U.S. Food and Drug Administration (FDA) for its new SagiNova(R)
afterloader. The receipt of approval marks yet another milestone in the
company's expansion in the U.S. brachytherapy market. North America is the
largest homogeneous market for brachytherapy, a form of radiation therapy
that applies radiation directly on the tumor location. Almost 40 % of all
tumor irradiation equipment installed worldwide is located at the 2,400
radiation therapy centers in the U.S. Temporary brachytherapy is especially
widely used for gynecological applications. However, its wide range of
potential applications also allows it to be used on other forms of cancer.
"Eckert & Ziegler BEBIG and Mick Radio-Nuclear Instruments, a U.S. company
that we acquired in 2013, have decades of experience in the field of HDR
technology. We estimate the annual market volume for tumor irradiation
systems in the U.S. to be almost EUR 50 million, and we're happy to play an
increasingly important role in this market," says Dr. Edgar Löffler, Member
of the Executive Board of Eckert & Ziegler AG in charge of the Radiation
Therapy segment.
SagiNova(R) is the only brachytherapy afterloader available with both a
Co-60 and an Ir-192 source with 510(k) approval.
HDR brachytherapy involves placing a miniaturized radiation source in the
tumor site for a short period of time and is an integral part of cancer
treatment. Patients often receive HDR brachytherapy as a stand-alone
treatment or in combination with external radiation therapy or
chemotherapy. Based on the age-standardized number of new cases per 100,000
inhabitants, 25 % more people develop cancer in the U.S. than in Europe.
SagiNova(R) will be unveiled to the public at ESTRO Forum, the annual
conference of the European Society for Radiotherapy & Oncology, in
Barcelona (April 24-28, 2015).
SagiNova(R) was awarded a CE mark in late 2014.
About Eckert & Ziegler
With around 700 employees, Eckert & Ziegler Strahlen- und Medizintechnik AG
(ISIN DE0005659700) is one of the world's largest providers of isotope
technology components for radiation therapy and nuclear medicine.
Contributing to saving lives
For enquiries, please contact:
Eckert & Ziegler AG, Karolin Riehle, Investor Relations
Robert-Rössle-Str. 10, 13125 Berlin, Germany
Tel.: +49 (0) 30 / 94 10 84-138, [email protected], www.ezag.com
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23.04.2015 Dissemination of a Corporate News, transmitted by DGAP - a
service of EQS Group AG.
The issuer is solely responsible for the content of this announcement.
The DGAP Distribution Services include Regulatory Announcements,
Financial/Corporate News and Press Releases.
Media archive at www.dgap-medientreff.de and www.dgap.de
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Language: English
Company: Eckert & Ziegler Strahlenund Medizintechnik AG
Robert-Rössle-Str.10
13125 Berlin
Germany
Phone: 49 30 941084-138
Fax: 49 30 941084-112
E-mail: [email protected]
Internet: www.ezag.de
ISIN: DE0005659700
WKN: 565970
Listed: Regulated Market in Frankfurt (Prime Standard), Stuttgart;
Regulated Unofficial Market in Berlin, Dusseldorf,
Hamburg, Munich
End of News DGAP News-Service
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