Healthcare Industry News:  Sonablate 500 

Devices Oncology

 News Release - August 18, 2009

US HIFU Announces Addition of Tissue Change Monitoring (TCM) Software to Sonablate(R) 500 Medical Device

CHARLOTTE, N.C., Aug. 18 -- (Healthcare Sales & Marketing Network) -- US HIFU, LLC, introduces a new software component, called Tissue Change Monitoring (TCM), to its Sonablate® 500 medical device that will enhance its existing minimally invasive treatment for prostate cancer using HIFU, high intensity focused ultrasound, by enabling physicians to monitor prostatic tissue changes in real-time.

Stephen Puckett, Jr., chief executive officer, US HIFU said, "TCM represents yet another major step forward for the Sonablate® HIFU platform. From a physician's perspective, it has the potential to significantly shorten the learning curve related to appropriate energy delivery. From a competitive perspective, TCM levels the playing field with MRI systems because TCM gives immediately feedback on what is happening to the tissue during treatment."

TCM is a unique, quantitative software module that provides feedback to the physician on the status of the ablative therapy in real-time so physicians know exactly what is happening to the prostatic tissue during HIFU. A radio frequency signal (RF) is sent to a precise site in the prostate before the physician treats it with ultrasound energy. Another signal is sent following the ultrasound delivery, which quantifies the change that actually took place. TCM results are color-coded and displayed on the Sonablate 500 screen and overlaid on a sagittal image, enabling doctors to determine immediately how much change there was in the tissue at that particular site.

TCM is already available in certain locations and US HIFU plans to begin a worldwide installation of TCM to move towards global standardization among Sonablate HIFU users.

TCM will be installed this week at the Institute of Urology at University College in London, where Mark Emberton, MD has performed more than 800 HIFU procedures.

"I have long been a user and advocate of the Sonablate 500 because it allows the physician to control the exact point where ultrasound energy is delivered and vary the intensity of the energy," said Dr. Emberton. "With the addition of TCM, physicians can determine immediately if the energy has been sufficient to successfully ablate the targeted prostate tissue and if not, the Sonablate allows users to make adjustments in real-time instead of completing a treatment phase and then reviewing the feedback."


US HIFU, LLC is a privately held healthcare company focused on treating primary and recurrent prostate cancer using HIFU, a minimally invasive outpatient procedure. US HIFU was founded in 2004 and is headquartered in Charlotte, N.C.

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 and is manufactured by Focus Surgery, Inc. Misonix, Inc. (Nasdaq: MSON ) holds distribution rights in Europe and Takai Hospital Supply Ltd. and THS International distribute the Sonablate® 500 in Southeast Asia and the Middle East. 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

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