27.01.2015 08:27:00
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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
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.
Language: | English | ||
Company: | MagForce AG | ||
Max-Planck-Straße 3 | |||
12489 Berlin | |||
Germany | |||
Phone: | +49 (0)30 308 380 0 | ||
Fax: | +49 (0)30 308 380 99 | ||
E-mail: |
info@magforce.com |
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Internet: |
www.magforce.com |
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ISIN: | DE000A0HGQF5 | ||
WKN: A0HGQF Listed: | Freiverkehr in Berlin, Düsseldorf, Stuttgart; Frankfurt in Open Market (Entry Standard) |
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