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MagForce AG: MagForce AG and MagForce USA, Inc. Announce FDA Pre-IDE Meeting on MagForce's NanoTherm(TM) Prostate Cancer Therapy Pre-Submission

DGAP-News: MagForce AG / Key word(s): Regulatory Admission
MagForce AG: MagForce AG and MagForce USA, Inc. Announce FDA Pre-IDE
Meeting on MagForce's NanoTherm(TM) Prostate Cancer Therapy
Pre-Submission

27.01.2015 / 08:00

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MagForce AG and MagForce USA, Inc. Announce FDA Pre-IDE Meeting on
MagForce's NanoTherm(TM) Prostate Cancer Therapy Pre-Submission

Berlin, Germany and Nevada, USA, January 27, 2015 - MagForce AG (Frankfurt,
Entry Standard, XETRA: MF6, ISIN: DE000A0HGQF5), a leading medical device
company in the field of nanomedicine focused on oncology, together with its
subsidiary MagForce USA, Inc. today announced that an in-person meeting was
held with the U.S. Food and Drug Administration's (FDA) Center for Devices
and Radiological Health to discuss FDA's response to MagForce's
NanoTherm(TM) Prostate Cancer Therapy Pre-Submission of November, 2014.

"We received very constructive feedback on our submission and have an
understanding of the pathway to market in the USA of NanoTherm(TM) Therapy
to focally ablate prostate cancer. MagForce USA, Inc. will accelerate the
prostate cancer Investigational Device Exemption (IDE) to utilize the MFH
300F NanoActivator(R) for both Glioblastoma and Prostate NanoTherm(TM)
Therapy registration," commented Dr. Ben J. Lipps, CEO of MagForce AG and
MagForce USA, Inc.

About MagForce AG and MagForce USA, Inc.

MagForce AG, listed in the entry standard of the Frankfurt Stock Exchange
(MF6, ISIN: DE000A0HGQF5), together with its subsidiary MagForce USA, Inc.
is a leading medical device company in the field of nanomedicine focused on
oncology. The Group's proprietary NanoTherm(TM) therapy enables the
targeted treatment of solid tumors through the intratumoral generation of
heat via activation of superparamagnetic nanoparticles. Mithril Capital
Management, a growth-stage technology fund founded by Ajay Royan and Peter
Thiel, along with MagForce AG, are investors and strategic partners in
MagForce USA, Inc.

NanoTherm(TM), NanoPlan(R), and NanoActivator(R) are components of the
therapy and have received EU-wide regulatory approval as medical devices
for the treatment of brain tumors. MagForce, NanoTherm(TM), NanoPlan(R),
and NanoActivator(R) are trademarks of MagForce AG in selected countries.

For more information, please visit: www.magforce.com.


Disclaimer

This release may contain forward-looking statements and information which
may be identified by formulations using terms such as "expects", "aims",
"anticipates", "intends", "plans", "believes", "seeks", "estimates" or
"will". Such forward-looking statements are based on our current
expectations and certain assumptions, which may be subject to a variety of
risks and uncertainties. The results actually achieved by MagForce AG may
substantially differ from these forward-looking statements. MagForce AG
assumes no obligation to update these forward-looking statements or to
correct them in case of developments, which differ from those, anticipated.

Contact:

Anne Hennecke
MC Services AG

T [phone]
F [phone]

Email: [e-mail]



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Language: English
Company: MagForce AG
Max-Planck-Straße 3
12489 Berlin
Germany
Phone: [phone]
Fax: [phone]
E-mail: [e-mail]
Internet: www.magforce.com
ISIN: DE000A0HGQF5
WKN: A0HGQF
Listed: Freiverkehr in Berlin, Düsseldorf, Stuttgart; Frankfurt in
Open Market (Entry Standard)


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