MagForce USA has submitted an investigational device exemption (IDE) application to the US Food and Drug Administration (FDA) for its NanoTherm therapy to treat risk prostate cancer.
The study treatment will use the firm’s NanoTherm technology to completely remove prostate cancer lesions.
MagForce noted that the IDE submission follows the submission of its pre-IDE submission to FDA in November, 2014 and a subsequent in-person meeting with FDA in January this year.
The company will enrol around 120 men in the proposed study, which is designed to demonstrate that NanoTherm can ablate cancer lesions for patients who have Gleason Score 7 prostate cancer and are under active surveillance.
MagForce CEO Dr Ben J. Lipps said: "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 therapy can fulfill the desired outcome. We look forward to working with the FDA and advancing the registration process in the USA."
Co-principal investigators of the study include San Antonio Cancer Therapy and Research Center director Dr Ian Thompson and University of Washington School of Medicine urology department professor Dr Dan Lin.
University of Washington School of Public Health department of health services chair professor Larry Kessler will also act as co-investigator of the study, involving in the Regulatory submission and registration processes.