MagForce AG: MagForce USA, Inc. has received FDA Approval to proceed with its Streamlined Trial Protocol for the next Stage of Pivotal U.S. Single-Arm Study for the Focal Ablation of Intermediate Risk Prostate Cancer with the NanoTherm Therapy System

MagForce AG / Key word(s): Study
MagForce AG: MagForce USA, Inc. has received FDA Approval to proceed with its Streamlined Trial Protocol for the next Stage of Pivotal U.S. Single-Arm Study for the Focal Ablation of Intermediate Risk Prostate Cancer with the NanoTherm Therapy System

27-Apr-2020 / 23:51 CET/CEST
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MagForce AG: MagForce USA, Inc. has received FDA Approval to proceed with its Streamlined Trial Protocol for the next Stage of Pivotal U.S. Single-Arm Study for the Focal Ablation of Intermediate Risk Prostate Cancer with the NanoTherm Therapy System

Berlin, Germany, and Nevada, USA, April 27, 2020 - 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., today announced that FDA approval for a streamlined trial protocol, for the next stage of the Company's pivotal U.S. study with the NanoTherm therapy system for the focal ablation of intermediate risk prostate cancer was received. The next stage of the clinical trial is being initiated with three well-respected urological centers in Texas, Washington and Florida who actively enrolled patients in Stage 1.

The streamlined procedure will allow the patient treatment to be completed within one day at one of MagForce's three out-patient treatment facilities and is possible because of limited side effects that were observed at each step of the procedure in Stage 1.

The next stage of the study will be conducted in phases to ensure early on that the minimal side effects observed in Stage 1, with a drawn out procedure, are maintained in the streamlined one day procedure. Treatment of the first 5 to10 subjects should be sufficient to affirm the minimal side effects as expected.

COVID-19 impact: While there are many restrictions that have been applied such as "Shelter at Home" and eliminating state to state travel via car or via plane; however, MagForce is still working diligently with its physician investigators. Exemptions exist for healthcare workers, such as MagForce's USA staff at MagForce USA clinical facilities. Clearly MagForce USA can conduct the trial in its out-patient facilities and has developed COVID-19 infection control procedures for staff and study subjects. All this effort has caused a certain delay but MagForce is confident the next stage of the clinical trial will not be unduly delayed since MagForce USA will conduct the trial from its facilities.

MagForce is still hopeful that the COVID-19 pandemic will not cause significant delay beyond 2020 to complete this single-arm clinical trial.

- End of Insider Information -

Contact:
MagForce AG, Max-Planck-Straße 3, 12489 Berlin
Barbara von Frankenberg
Vice President Communications & Investor Relations
T +49-30-308380-77
E-Mail: bfrankenberg@magforce.com

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