Glioblastoma study in the US

As a next step, the glioblastoma study will be expanded to the US. For the US, MagForce had a pre-submission meeting with the U.S. Food and Drug Administration (FDA) in May 2014, talking about developing NanoTherm® therapy for glioblastoma (GBM). During this meeting MagForce introduced the therapy to the agency and discussed the regulatory requirements to enable product registration and approval in the US. The FDA provided very constructive feedback and confirmed that, similar to Europe, NanoTherm® therapy will be designated as a medical device in the US. On this basis, the Company has started a dialogue with US opinion leaders, in order to conduct an application trial with NanoTherm® therapy and to prepare the US registration path. The Company is confident that MagForce's extensive pre-clinical and clinical studies will provide the solid background for a timely submission of an Investigational Device Exemption (IDE) for the development of NanoTherm® therapy in the US.