, May 8, 2014
/PRNewswire/ -- SonaCare Medical, LLC, a leader in minimally invasive high intensity focused ultrasound (HIFU) technology, today announced that the U.S. Food and Drug Administration (FDA) has tentatively scheduled a Gastroenterology and Urology Devices Advisory Committee Panel meeting on October 2, 2014
to review the Company's Premarket Approval (PMA) application for Sonablate® 450 for the treatment of recurrent prostate cancer following external beam radiation treatment (EBRT) in the U.S.
"We are pleased that the date for the FDA advisory panel meeting has been set and look forward to the opportunity to present our findings from the Sonablate® 450 clinical trial." commented Michael Klein, CEO of SonaCare Medical. "If approved, Sonablate® 450 will provide U.S. physicians and patients with the only therapeutic option approved by the FDA specifically for the treatment of recurrent prostate cancer. If approved, Sonablate® 450 will provide a new therapeutic option to a patient population that has few alternatives."
Confirmation and details of the meeting will be published in the Federal Register approximately six to eight weeks prior to the scheduled meeting date. Please note that until this panel meeting is announced in the Federal Register, it is considered tentative and could be postponed or cancelled. The Federal Register notice will be available at the following website: http://www.fda.gov/RegulatoryInformation/Dockets/FR/default.htm.
About Sonablate® 450
The Sonablate® 450 medical device is investigational in the U.S. and being studied in a pivotal FDA clinical trial as a possible treatment for recurrent prostate cancer in patients treated previously with external beam radiation therapy.
About SonaCare Medical
SonaCare Medical, LLC a privately held, venture-backed healthcare company is a world leader in minimally invasive high intensity focused ultrasound (HIFU) technologies. SonaCare Medical is committed to developing technologies for urological indications that offer precise and innovative procedures that can control cancer and reduce potential quality of life altering side effects.
Forward Looking Statements
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. These statements can be identified by the fact that they do not relate strictly to historical or current facts. Forward-looking statements often include words such as "anticipates," "estimates," "expects," "projects," "intends," "plans," "believes" and words and terms of similar substance in connection with discussions of future operating or financial performance. SonaCare Medical's forward-looking statements are based on management's current expectations and other future conditions and forecasts of future events, circumstances and results which are inherently susceptible to uncertainty and changes in circumstances. SonaCare Medical's actual results may vary materially from those expressed or implied in its forward-looking statements.
SOURCE SonaCare Medical, LLC