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MagForce AG: MagForce USA, Inc. has Received FDA's Conditions for Approval of the Final Protocol of the Pivotal U.S. Study for the Focal Ablation of Prostate Cancer with the NanoTherm Therapy System

DGAP-News: MagForce AG / Key word(s): Study MagForce AG: MagForce USA, Inc. has Received FDA's Conditions for Approval of the Final Protocol of the Pivotal U.S. Study for the Focal Ablation of Prostate Cancer with the NanoTherm Therapy System 13.10.2021 / 08:30 The issuer is solely responsible for the content of this announcement. MagForce AG: MagForce USA, Inc. has Received FDA's Conditions for Approval of the Final Protocol of the Pivotal U.S. Study for the Focal Ablation of Prostate Cancer with the NanoTherm Therapy System

Berlin, Germany and Nevada, USA, October 13, 2021 - 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., announced today that the U.S. Food and Drug Administration (FDA) has provided MagForce USA, Inc. with the conditions for approval of the final clinical protocol for the clinical study for the focal ablation of prostate cancer. These conditions consist of clarifications of definitions and additions of certain administrational measures to the protocol.

MagForce is pleased that the FDA's conditions include using the final protocol in Stage 2b with targeted biopsy to assess effectiveness. MagForce believes the FDA conditions are reasonable, and files the necessary documentation with the authority. MagForce expects to receive final clearance to commence Stage 2b in November 2021. Until then patient screening will be expedited at MagForce's NanoTherm treatment centers.

Stage 2b and the final protocol of the single-arm pivotal study are planned to evaluate the use of NanoTherm ablation as a method of treating prostate cancer patients with intermediate grade lesions, thereby allowing up to 100 patients to return to active surveillance without definitive treatment such as external beam radiation or prostatectomy. The subjects will have intermediate risk prostate cancer but their prostate cancer has progressed to a stage where a clinical review and treatment change is required. The trial is designed to demonstrate that the NanoTherm therapy system can focally ablate targeted prostate cancer lesions with minimal side effects. The streamlined procedure will continue to be used for the remainder of the clinical trial.