/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.