BERLIN & CARSON CITY, Nev.--(BUSINESS WIRE)--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 the USA.," Dr. Ben J. Lipps added.
About MagForce AG and MagForce USA, Inc.
MagForce AG, listed in the entry standard of the Frankfurt Stock Exchange (MF6, ISIN: DE000A0HGQF5), together with its subsidiary MagForce USA, Inc. is a leading medical device company in the field of nanomedicine focused on oncology. The Group's proprietary NanoTherm(TM) therapy enables the targeted treatment of solid tumors through the intratumoral generation of heat via activation of superparamagnetic nanoparticles. Mithril Capital Management, a growth-stage technology fund founded by Ajay Royan and Peter Thiel, along with MagForce AG, are investors and strategic partners in MagForce USA, Inc.
NanoTherm(TM), NanoPlan(R), and NanoActivator(R) are components of the therapy and have received EU-wide regulatory approval as medical devices for the treatment of brain tumors. MagForce, NanoTherm(TM), NanoPlan(R), and NanoActivator(R) are trademarks of MagForce AG in selected countries.
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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: firstname.lastname@example.org Internet: www.magforce.com ISIN: DE000A0HGQF5 WKN: A0HGQF Listed: Regulated Unofficial Market in Berlin, Dusseldorf, Stuttgart; Open Market (Entry Standard) in Frankfurt End of News DGAP News-Service