US HIFU has received approval from its Data and Safety Monitoring Board (DSMB) to continue enrollment in its FDA-approved clinical trial investigating the use of HIFU technology delivered via the Sonablate 500 (Sonablate HIFU) medical device to treat localized primary prostate cancer.
US HIFU, a provider of minimally invasive high intensity focused ultrasound (HIFU) technologies, said that it intends to submit the completed data to the FDA in support of its request for commercial approval to treat primary prostate cancer in the US.
US HIFU said that the 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.
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 US.
Steve Puckett, CEO of US HIFU, said “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 US in the near future.”
Dawn Rice, director of clinical affairs, said: “We are proud to have 18 well-known and respected institutions on board as our current trial sites. 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.”