MagForce - FDA approves streamlined trial protocol
MagForce has received FDA approval to proceed with its streamlined trial protocol for the next stage of its pivotal US clinical study for the use of NanoTherm in prostate cancer. This follows completion of the first 10-patient cohort in its pivotal prostate cancer study and means the next stage of the US focal ablation study can be initiated. MagForce will enrol up to 120 patients with stage 1 prostate cancer to establish efficacy in thermally ablating prostate cancer lesions with minimal side effects. Positive results would be a critical value inflection, and we now expect approval and launch in Q121 (previously Q420). NanoTherm’s US prostate indication contributes 70% to our valuation of MagForce, which is €303.1m.MagForce is engaged in the research, development, manufacturing, and commercialization of medical devices and therapies for the treatment of solid, localized cancer tumors. Co.'s targeted cancer treatment, NanoTherm™ therapy, consists of three interrelated components: NanoTherm™, magnetic fluid containing iron-oxide nanoparticles, NanoActivator®, magnetic field applicator and NanoPlan®, treatment planning software. These three products are manufactured within Co. and are classified, in the European Union, as medical devices. Co. is focused on treatments for glioblastoma and prostate cancer.
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