CHARLOTTE, N.C., July 9 /PRNewswire/ -- USHIFU, LLC, a global leader in non invasive high intensity focused ultrasound (HIFU) technology, is proud to announce sponsorship of the Sonablate(R) International HIFU Registry (SIHR), along with co-sponsors Misonix, Inc. and Takai Hospital Supply Co., Ltd., (THS). The SIHR is the first and only worldwide registry to gather information about prostate cancer treatment using HIFU. It was established to offer a single, secure, standardized repository of treatment information for users of the Sonablate(R) technology.
The SIHR is a truly independent database; it is stored in a secure online environment by an independent IT company. The information gathered will be reviewed and analyzed by independent, third-party statisticians. At no point do the sponsoring organizations have access to the raw dataset. Registry oversight will be provided by a steering committee consisting of senior Sonablate(R) HIFU users from five different countries, including Mark Emberton, M.D., London, England; Rowland Illing, M.D., London, England; Stephen Scionti, M.D., Hilton Head, SC; Michael Marberger, M.D., Vienna, Austria; and Prof. Toyoaki Uchida, Tokyo, Japan.
"The Sonablate(R) International HIFU Registry was created to capture the 'real life' practice of prostate cancer treatment, which for the most part fell outside the responsibility of clinical trials," said Dr. Illing of the Clinical Effectiveness Unit at the Royal College of Surgeons of England. "Sponsorship of this registry by the worldwide distribution partners of the Sonablate(R) demonstrates their high level of confidence in the technology. The SIHR will be an incredibly powerful tool for continuing medical education, as it will allow the identification and dissemination of best practice. It will also provide a comprehensive international dataset with which to assess the determinants of outcome."
Steve Puckett, Jr., CEO of USHIFU said, "We believe that setting up an international database controlled and monitored by highly reputable physicians will produce a data set that is credible and compelling to the broader clinical community. It will capture the realistic outcomes achieved by physicians in private practice in approved markets, which is highly valuable, in addition to controlled protocol-driven data that is being collected in the FDA clinical trials."
Michael A. McManus, Jr., President and CEO of Misonix said, "The start of this registry will provide information on the more than 6,000 patients that have been treated with the Sonablate(R) 500 for prostate cancer around the world outside of the U.S. It will also enable doctors who are presently involved in clinics or who are treating patients on a regular basis to input their data. The medical community and patients will benefit from the availability of this information that will show the history and the successful treatment record of prostate cancer procedures using the Sonablate(R) 500 for a period of more than five years."
David Quigley, President and CEO of THS said, "We are excited to let the medical community know the consistent and excellent clinical results we are experiencing around the world with the Sonablate 500. We think the Sonablate registry will be a win-win scenario for patients and our users."
About USHIFU, LLC
USHIFU is a healthcare development company and medical device distributor committed to creating a new standard for prostate cancer treatment with high intensity focused ultrasound (HIFU) therapy. USHIFU works with hospitals and medical centers in countries where HIFU is authorized for treating prostate cancer, including Canada, Mexico, the Dominican Republic and the Bahamas, to make the non invasive therapy available. USHIFU is also funding FDA-approved clinical trials in the United States to gather data important for analysis of the technology by the FDA. The first is a pivotal trial for the treatment of primary organ confined prostate cancer that will enroll 466 participants at 24 different centers. A second pivotal trial will begin for the treatment of recurrent prostate cancer in men who have failed external beam radiation therapy. This single arm study will enroll 202 participants at 10 different sites.
About the Sonablate(R) 500
The Sonablate(R) 500 is a non invasive medical device that utilizes ultrasound energy to destroy tissue within the body. It was developed by FSI and is manufactured by Misonix, Inc. who also holds distribution rights in Europe. Takai Hospital Supply Ltd. and THS International distribute the Sonablate(R) 500 in Southeast Asia and the Middle East.
The Sonablate(R) 500 is not approved for use in the U.S. The Sonablate(R) 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(R) 500 for the treatment of prostate cancer.
