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MagForce AG: MagForce USA, Inc. files Investigational Device Exemption for NanoTherm(TM) Therapy to Treat Intermediate Risk Prostate Cancer

DGAP-News: MagForce AG / Key word(s): Miscellaneous
MagForce AG: MagForce USA, Inc. files Investigational Device Exemption
for NanoTherm(TM) Therapy to Treat Intermediate Risk Prostate Cancer

21.05.2015 / 07:15

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MagForce USA, Inc. files Investigational Device Exemption for NanoTherm(TM)
Therapy to Treat Intermediate Risk Prostate Cancer

Berlin, Germany and Nevada, USA, May 21, 2015 - MagForce USA, Inc., a
majority owned subsidiary of MagForce AG (Frankfurt, Entry Standard, XETRA:
MF6, ISIN: DE000A0HGQF5), a leading medical device company in the field of
nanomedicine focused on oncology, announced today it has filed an
Investigational Device Exemption (IDE) with the USA Food and Drug
Administration (FDA). The study treatment uses MagForce's proprietary
NanoTherm(TM) technology to completely ablate prostate cancer lesions.

This IDE submission follows the submission of our pre-IDE submission to FDA
in November, 2014 and a subsequent in-person meeting with FDA in January,
2015. The purpose of the proposed study that will enroll up to 120 men is
to demonstrate that NanoTherm(TM) can ablate cancer lesions for patients
who have Gleason Score 7 prostate cancer and are under active surveillance.
By ablating the lesions, patients will be able to maintain active
surveillance and avoid surgery and other treatments all with well-known
side effects like impairment of urinary and sexual functions. Dr. Ian M.
Thompson, Jr., Director, Cancer Therapy and Research Center, a National
Cancer Institute-designated Cancer Center at the University of Texas Health
Science Center at San Antonio and Dr. Dan W. Lin, Chief of Urologic
Oncology and Professor in the Department of Urology at the University of
Washington School of Medicine in Seattle have agreed to be Co-Principal
Investigators. Larry Kessler, Sc.D., Professor and Chair of the Department
of Health Services, School of Public Health at the University of Washington
is also a Co-Investigator overseeing the Regulatory Submission and
Registration processes. "This is indeed a significant milestone for
MagForce USA, Inc. and MagForce AG. Potentially 100,000 men in active
surveillance programs could benefit from this Focal therapy after
registration in the USA. We believe the registration clinical trial will
prove that NanoTherm(TM) therapy can fulfill the desired outcome. We look
forward to working with the FDA and advancing the registration process in