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 --------------------------------------------------------------------- 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 +49 211 529252-22 F +49 211 529252-29 Email: anne.hennecke@mc-services.eu --------------------------------------------------------------------- 27.01.2015 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 --------------------------------------------------------------------- Language: English Company: MagForce AG Max-Planck-StraÃe 3 12489 Berlin Germany Phone: +49 (0)30 308 380 0 Fax: +49 (0)30 308 380 99 E-mail: info@magforce.com Internet: www.magforce.com ISIN: DE000A0HGQF5 WKN: A0HGQF Listed: Freiverkehr in Berlin, Düsseldorf, Stuttgart; Frankfurt in Open Market (Entry Standard) End of News DGAP News-Service --------------------------------------------------------------------- 316499 27.01.2015
DGAP-News: MagForce AG: MagForce AG and MagForce USA, Inc. Announce FDA Pre-IDE Meeting on MagForce's NanoTherm(TM) Prostate Cancer Therapy Pre-Submission
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