MagForce AG / Key word(s): Study
MagForce AG receives FDA Investigational Device Exemption approval to conduct a clinical trial with NanoTherm Therapy as Focal Ablation Treatment for Intermediate Risk Prostate Cancer
10-Feb-2018 / 10:38 CET/CEST
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MagForce receives FDA Investigational Device Exemption approval to conduct a clinical trial with NanoTherm Therapy as Focal Ablation Treatment for Intermediate Risk Prostate Cancer
Berlin, Germany and Nevada, USA, February 10, 2018 – MagForce AG (Frankfurt, Scale, XETRA: MF6, ISIN: DE000A0HGQF5), a leading medical device company in the field of nanomedicine focused on oncology, together with its subsidiary MagForce USA, Inc., announces that it has received U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE) approval to conduct a clinical trial with NanoTherm therapy as focal ablation treatment for intermediate risk prostate cancer.
The approval of this IDE now allows MagForce to conduct a pivotal clinical evaluation with the Company’s innovative NanoTherm therapy at selected medical centers in the US. MagForce anticipates to initiate patient enrollment in this study in the coming months.
The purpose of this focal thermal ablation registration study that will enroll up to 120 men in a single arm study is to demonstrate that NanoTherm can focally ablate cancer lesions for patients who have advanced to intermediate risk prostate cancer stage and are under active surveillance. By focally ablating these cancer lesions, it is anticipated that patients will be able to be maintained in Active Surveillance Programs and to avoid definitive therapies such as surgery or whole gland radiation with their well-known side effects.
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