Loading...
Loading...
EDAP TMS SA
EDAP, the
global leader in therapeutic ultrasound, announced today the submission of its
Pre-Market Approval (PMA) application to the U.S. Food and Drug Administration
(FDA) on January 31, 2013 for the Company's Ablatherm-HIFU (High Intensity
Focused Ultrasound) for treatment of low risk, localized prostate cancer.
EDAP's PMA submission includes data from the ENLIGHT study, a multi-center
U.S. Phase II/III clinical trial that completed the two year follow-up needed
to evaluate its primary endpoint in August 2012, as well as data from the
Company's extensive worldwide database of treatment information and follow-up
data from patients who have undergone HIFU therapy for prostate cancer.
Prostate cancer is currently the most common form of cancer among men in the
United States with approximately 238,000 new cases for 2013. In addition, men
are being diagnosed at an earlier age and at earlier stages of the disease.
© 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
Benzinga simplifies the market for smarter investing
Trade confidently with insights and alerts from analyst ratings, free reports and breaking news that affects the stocks you care about.
Join Now: Free!
Already a member?Sign in