May 6 2014
MagForce AG (Frankfurt, Entry Standard), 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.
About MagForce AG
MagForce AG, listed in the entry standard (MF6), together with its subsidiary MagForce USA, Inc. is a leading medical device company in the field of nanomedicine in oncology. The Group'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(TM) 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(TM) are trademarks of MagForce AG in selected countries. For more information, please visit www.magforce.com.
Source: http://www.magforce.com/