Posted in | Nanomedicine

MagForce Holds Pre-IDE Meeting with FDA on NanoTherm 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.

Source: http://www.magforce.com/

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