| US HIFU Adds Software to Investigational Treatment Device |
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US HIFU Adds Software to Investigational Treatment Device In early August, US HIFU, LLC, the Charlotte, NC company responsible for promoting the Sonablate 500 HIFU delivery device, announced the addition of a new software program to the Sonablate. Tissue Change Monitoring makes HIFU (high intensity focused ultrasound) even more effective as a non-invasive prostate cancer treatment option. Tissue Change Monitoring (TCM) allows the administering physician to monitor changes in prostatic tissue in real time. The Sonablate 500 is a non-invasive treatment device that destroys prostatic tissue, including cancer, using ultrasound energy to heat and destroy the tissue. According to Stephen Puckett, Jr., chief executive officer of US HIFU, the software addition gives physicians the ability to deliver the most effective amount of sound energy to the prostate gland without the trial-and-error methods common before, when physician had to rely on MRI imaging before and after treatment to determine the extent of tissue destruction. The new software allows the physician access to real time data by using a radio frequency signal before and after ultrasound delivery. Before the ultrasound energy is sent into the prostate gland, radio frequency signal is sent into the gland and recorded on the computer. Once the ultrasound delivery is done, the signal is repeated, and the computer quantifies the change in tissue. The results, which are color-coded, are shown to the physician on the Sonablate 500 screen, so doctors can instantly see the change in the tissue. Currently, the Sonablate 500 is being used in treatment centers around the globe to provide a non-invasive treatment for prostate cancer patients that greatly lowers many of the common risks associated with prostate cancer treatment. The device is in Stage III clinical trials in the United States, but has not yet received FDA approval for use in the U.S. Many patients travel outside of the U.S. to receive treatment with the Sonablate 500. CM is currently being used in several HIFU treatment centers around the globe. Soon, US HIFU will globalize the software, ensuring that every facility equipped with the Sonablate 500 also have the TCM software. One of the most recent treatment centers to receive the new technology is the Institute of Urology at University College in London. Here, Dr. Mark Emberton has performed close to 1000 HIFU procedures. When asked about the new software, Dr. Emberton indicated that he was extremely pleased. He said that now, "physicians can determine immediately if the energy has been sufficient to successfully ablate the targeted prostate tissue." If the treatment is not strong enough, the design of the Sonablate allows the physician to make adjustments and deliver more energy to the gland. This is an improvement over prior techniques, which required the physician to complete the procedure, and then take scans to determine whether or not it was effective. If the physician found that the tissue was not completely destroyed, a repeat procedure was necessary. TCM helps physician ablate the prostate gland and tumors completely on the first session of HIFU, lowering the "learning curve" for physicians who are new to the treatment modality, and increasing overall effectiveness of the treatment option. |