Magforce AG (DE:MF6G) has received IDE approval to start its first pivotal clinical trial evaluating NanoTherm focal ablation therapy for prostate cancer in the US. This is a major milestone for the company. Prostate cancer in the US presents a significant market opportunity (representing ~60% of our rNPV) and makes sense strategically as a first US indication. The start of this trial will broaden the geographic and therapeutic reach of NanoTherm therapy beyond Europe, where it is already approved for brain cancer. Our updated valuation is €302.6m.
Prostate IDE approved: US trials to initiate shortly
The original investigational device exemption (IDE) was filed in May 2015 and during 2016 and 2017 MagForce USA updated its preclinical NanoTherm study data to meet FDA standards. Importantly, ahead of the IDE approval, MagForce USA has installed two NanoActivators in two different clinical sites (Seattle and San Antonio). Patient recruitment for focal ablation therapy in 120 advanced to intermediate-risk prostate cancer patients should start promptly (within months). NanoTherm could be approved and launched for treatment of prostate cancer patients by the end 2019.
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