US HIFU Receives Unanimous Approval to Continue the Clinical Investigation of High Intensity Focused Ultrasound (HIFU) for Treatment of Prostate Cancer

CHARLOTTE, N.C., May 3 /PRNewswire/ -- US HIFU, a worldwide leader in the development, distribution and use of minimally invasive high intensity focused ultrasound (HIFU) technologies, received unanimous approval from its Data and Safety Monitoring Board (DSMB) to continue enrollment in its FDA-approved prospective clinical trial investigating the use of high intensity focused ultrasound (HIFU) technology delivered via the Sonablate® 500 ("Sonablate HIFU") medical device to treat localized primary prostate cancer. US HIFU intends to submit the completed data to the FDA in support of its request for commercial approval to treat primary prostate cancer in the U.S.

Sonablate HIFU destroys diseased prostatic tissue with extreme heat generated from focused ultrasound waves. The ultrasound energy is delivered in rapid-fire succession to targeted tissue throughout the gland. The tissue at each target is destroyed while surrounding tissue remains unharmed.

The DSMB, an independent group of experts that monitors clinical data to ensure patient safety during any clinical trial process, made no changes to the existing criteria following its review from the initial cohort of enrolled patients.

"This is quite an exciting milestone in this process. Unanimous approval from the board reaffirms that we are right on track with our study," said US HIFU CEO Steve Puckett, Jr. "I am confident that we will complete the trial and certainly remain hopeful that this minimally invasive prostate cancer treatment will be available in the U.S. in the near future."

Additionally, US HIFU continues active enrollment in the FDA-approved prospective clinical trial investigating Sonablate HIFU for the treatment of recurrent prostate cancer.  As with the primary prostate cancer clinical trial, US HIFU intends to submit this completed trial data to the FDA in support of its request for commercial approval to treat recurrent prostate cancer in the U.S.

"We are proud to have 18 well-known and respected institutions on board as our current trial sites," said Dawn Rice, director of clinical affairs. "We are working diligently to round out the list of sites as well as to enroll additional participants in both the recurrent and primary trial."

For additional clinical trial information, including participation criteria for either trial, please contact the director of clinical affairs at (678) 896-1575 or [email protected].

About USHIFU US HIFU (USHIFU, LLC), a privately held healthcare company, is a world leader in minimally invasive high intensity focused ultrasound (HIFU) technologies. US HIFU manufactures the Sonablate® 500 medical device and is focused currently on treating primary and recurrent prostate cancer using Sonablate® HIFU. The company is engaged in ongoing research for technological advancements for the Sonablate® system or other ultrasound applications.

About the Sonablate® 500 The Sonablate® 500 is a minimally invasive medical device that utilizes ultrasound energy to destroy tissue within the body. It was developed by Focus Surgery, Inc. and is manufactured in part by Misonix, Inc. (Nasdaq: MSON), which also holds distribution rights in Europe. Takai Hospital Supply Ltd. distributes the Sonablate® 500 in Southeast Asia. The Sonablate® 500 is not approved for use in the U.S. The Sonablate® 500 remains investigational in the U.S. and is being studied for the treatment of prostate cancer in clinical trials in the U.S. FDA has made no decision as to the safety or efficacy of the Sonablate® 500 for the treatment of prostate cancer.

SOURCE US HIFU