DGAP-Adhoc: 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

2018. február 10., szombat, 10:38





DGAP-Ad-hoc: 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.



Contact:

Barbara von Frankenberg

Vice President

Communications & Investor Relations

T +49-30-308380-77

E-Mail: bfrankenberg@magforce.com











10-Feb-2018 CET/CEST The DGAP Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.
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Language: English
Company: MagForce AG

Max-Planck-Straße 3

12489 Berlin

Germany
Phone: +49 (0)30 308 380 0
Fax: +49 (0)30 308 380 99
E-mail: info@magforce.com
Internet: www.magforce.com
ISIN: DE000A0HGQF5
WKN: A0HGQF
Listed: Regulated Unofficial Market in Berlin, Dusseldorf, Frankfurt (Scale), Stuttgart, Tradegate Exchange





 
End of Announcement DGAP News Service




653291  10-Feb-2018 CET/CEST







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