Navigation Links
Sonablate(R) International HIFU Registry is the First Worldwide HIFU Clinical Registry for Prostate Cancer Treatments
Date:7/9/2008

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. (Nasdaq: MSON) 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. (Nasdaq: MSON) 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.


'/>"/>
SOURCE USHIFU
Copyright©2008 PR Newswire.
All rights reserved

Related medicine technology :

1. ABC News NIGHTLINE Features HIFU with Sonablate(R) 500 as Non Invasive Treatment Option for Prostate Cancer
2. Intellect Neurosciences, Inc. to Present Data on Alzheimers Vaccine at 13th International Congress of Immunology Conference
3. Paper in International Journal of Oncology Reports Alfacells ONCONASE(R) Suppresses Intracellular Oxidative Stress
4. Ozarelix Phase 2 Data Presented at 29th Congress of the Societe Internationale dUrologie
5. Anadys Pharmaceuticals Presents Preclinical Results on ANA598, a Non-Nucleoside Inhibitor of the NS5B Polymerase, at the 14th International Symposium on Hepatitis C Virus and Related Viruses
6. International Expert Group Initiates Largest Multi-center Phase III Trial to Evaluate NeuroAid(TM) in Stroke Recovery
7. Surface Logix Presents Positive Phase 1 Repeat-Dose Trial Data on SLx-4090 at The 16th International Symposium on Drugs Affecting Lipid Metabolism
8. Preclinical Data on Lead MEK Inhibitor, RDEA119, to be Presented at the 2007 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics
9. Tumor Growth Inhibition and Pharmacokinetic Profile of NKTR-102 (PEG-Irinotecan) in Multiple Solid Tumors To Be Presented at Upcoming AACR-NCI-EORTC International Conference
10. Preimplantation Genetic Diagnosis International Society Refutes American Society of Reproductive Medicine Opinion - States Preimplantation Genetic Screening is Beneficial When Performed in Experienced Centers
11. Survival Data for Avicenas Amyotrophic Lateral Sclerosis Drug Candidate, AL-02, to be Presented at 18th International Symposium on ALS/MND
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/4/2017)... 2017  A new tight-tolerance microextrusion medical tubing ... materials, is being launched by Natvar, a Tekni-Plex ... in recent years to service a wide variety ... More expensive materials such as glass and fluoropolymers ... to their ability to consistently hold tolerances. This ...
(Date:5/3/2017)... 2017  Kalorama Information notes that transplant diagnostics ... year and this is projected to continue to ... (HSCT) or bone marrow transplants require histocompatibility between ... for this task. This according to a new ... The various PCR-based methodologies, Sanger sequencing and NGS ...
(Date:5/2/2017)... NEW YORK and LONDON ... distributor of market intelligence, MarketResearch.com is pleased to announce ... Consulting AB that allows for the marketing and ... market analyses through the MarketResearch.com website. The ... access to complete product descriptions and tables of contents ...
Breaking Medicine Technology:
(Date:5/27/2017)... ... May 27, 2017 , ... Most us are familiar with ... new study from the Osteoarthritis Initiative shows that certain people who experience ... this in advance may give doctors the opportunity to treat patients before the problem ...
(Date:5/26/2017)... ... May 26, 2017 , ... Leading CEOs from ... May 30th and 31st at The Four Seasons Hotel Boston. , The ... life sciences, offering exclusive access to key decision makers who influence deal making ...
(Date:5/26/2017)... Clara, Calif. (PRWEB) , ... May 26, 2017 ... ... announces the integration of the CareFusion NOX-T3 portable sleep monitor with its Somnoware ... provides a consistent, browser-based interface for diagnostic device operations. With this platform, initializing ...
(Date:5/26/2017)... ... May 26, 2017 , ... via ... antimicrobial, mesh back 24/7 task chair specifically designed for clinical areas. Genie Copper ... thrilled to partner with Cupron® to provide customers with a game changing chair ...
(Date:5/26/2017)... ... May 26, 2017 , ... Yisrayl Hawkins, Pastor and Overseer at The House ... focusing on the Peace Agreements being discussed by President Donald Trump and the rest ... to try to speed up peace talks in the continuous battle between Israel and ...
Breaking Medicine News(10 mins):