Frankfurt / Berlin, Germany and Nevada, USA, 5-5-2014 — /EuropaWire/ — Nanostart-holding MagForce, a leading medical device company in the field of nanomedicine focused on oncology, together with its subsidiary MagForce USA, Inc. are pleased to report 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® Therapy Pre-Submission of late December, 2013.
“We received very constructive feedback on our submission and have a better understanding of the issues and process for registration of NanoTherm® therapy in the USA. MagForce USA, Inc. will lead with the treatment of recurrent Glioblastoma in concert with MagForce AG’s post marketing clinical trial in Germany, which has already begun enrolling patients. We are confident that MagForce AG’s extensive pre-clinical and clinical studies will provide the background for a timely submission of an Investigational Device Exemption (IDE) for the application of NanoTherm® Therapy,” commented Ben J. Lipps, CEO of MagForce AG and MagForce USA.
Assisting MagForce with its USA registration efforts are Drs. Larry Kessler, Professor and Chair of the Department of Health Services School of Public Health, University of Washington, and Donna-Bea Tillman, Ph.D., M.P.A., FRAPS, of Biologics Consulting Group, Alexandria, VA.
Nanostart AG is a leading nanotechnology venture capital company. The company invests venture capital (VC) in promising young nanotechnology companies. Nanostart invests globally and at different phases of development. Emphasis of investments is on especially innovative industries such as cleantech, life sciences, and IT/electronics. Nanostart invests either directly in nanotechnology companies or through a regional nanotechnology fund. The headquarters of Nanostart AG is in Frankfurt, Germany.
About MagForce AG:
MagForce AG is a leading medical technology company in the field of nanomedicine in oncology. The Company’s proprietary, NanoTherm® therapy, enables the targeted treatment of solid tumors through the intratumoral generation of heat via activation of superparamagnetic nanoparticles. NanoTherm®, NanoPlan®, and NanoActivator™ are components of the therapy and have received EU-wide regulatory approval as medical devices for the treatment of brain tumors. MagForce, NanoTherm®, NanoPlan®, and NanoActivator™ are trademarks of MagForce AG in selected countries. For more information, please visit www.magforce.com.
About NanoTherm Therapy:
The NanoTherm® Therapy is a new approach for the local treatment of solid tumors. The principle of the method is the direct introduction of superparamagnetic nanoparticles into a tumor and their subsequent heating in an alternating magnetic field. The nanoparticles are extremely small (approximately 15 nanometers in diameter) and contain an iron oxide core with an aminosilane coating. The particles are activated by a magnetic field that changes its polarity 100,000 times per second, and heat is produced. Depending on the duration of treatment and the achieved intratumoral temperatures, the tumor cells are either directly destroyed (thermal ablation) or sensitized for concomitant chemotherapy or radiotherapy (hyperthermia). With this new therapeutic approach, it is possible to combat the tumor from the inside out, thereby sparing surrounding healthy tissue. The nanoparticles remain in place at the treatment area, allowing for repeat treatments and the integration of multimodal therapy concepts. NanoTherm® Therapy has regulatory approval in 27 European countries.
This notice constitutes neither an offer to sell nor a solicitation of offers to purchase or subscribe to securities. There will be no public offering of securities of Nanostart AG in conjunction with the existing listing of its shares in the “Entry Standard” segment of the regulated unofficial market (Freiverkehr) on the Frankfurt Stock Exchange. This notice does not constitute a securities prospectus. Neither this notice nor the information contained within is intended for direct or indirect distribution within Canada, Australia, or Japan.
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