Navigation Links
FDA Approves HIFU Clinical Trial for Recurrent Prostate Cancer
Date:5/13/2008

DELAND, Fla., May 13 /PRNewswire/ -- USHIFU, LLC, the clinical trial management provider for Focus Surgery, Inc. (Indianapolis, IN), is pleased to announce conditional written approval pending minor changes to the protocol from the FDA to begin a pivotal trial for the treatment of recurrent prostate cancer with the Sonablate(R) 500 in men who have failed external beam radiation therapy.

Dr. Herbert Lepor, Chairman of Urology at NYU School of Medicine and medical monitor for the trial said, "It is my pleasure to serve as the medical monitor for the prostate cancer clinical trial program evaluating the safety and effectiveness of the Sonablate(R) 500 HIFU device."

"I have personally reviewed the preliminary data and observed the Sonablate(R) 500 in action and I am impressed with this advanced technology for ablating the prostate. These rigorous clinical trials will help define the appropriate role of the Sonablate(R) 500 device in the treatment of prostate cancer," Lepor added.

This trial will be conducted at various sites across the U.S. and is expected to enroll approximately 202 subjects and 10 clinical centers. This clinical trial is based on results from the feasibility trial completed in October 2007 which enrolled 11 subjects from two clinical research sites within the U.S. Ten of the eleven subjects had failed external beam radiation therapy prior to participating in the clinical trial. The results of this feasibility trial provided a basis for the pivotal study. Additional studies are still needed to satisfy the safety and effectiveness standards, including long term outcomes, set by the FDA for marketing approval.

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.

The Sonablate(R) 500 was developed by Focus Surgery, Inc. 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.


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

Related medicine technology :

1. U.S. Food and Drug Administration Approves ORENCIA(R) (abatacept) for the Treatment of Moderate-to-Severe Polyarticular Juvenile Idiopathic Arthritis (JIA) in Patients Six Years and Older
2. U.S. Food and Drug Administration Approves ABILIFY(R) (aripiprazole) for the Acute Treatment of Manic and Mixed Episodes Associated With Bipolar I Disorder in Pediatric Patients (10 to 17 Years of Age)
3. UM Maryland Industrial Partnerships Program Approves 18 Collaborative Research Projects, Worth $4.4 Million, Between University Faculty, State Technology Companies
4. FDA Approves XYZAL(R) (levocetirizine dihydrochloride) Oral Solution for the Relief of Seasonal and Year Round Allergies and Chronic Idiopathic Urticaria
5. FDA Approves MiddleBrooks Amoxicillin PULSYS for Pharyngitis/Tonsillitis in Adolescents and Adults
6. European Commission Approves ATRIPLA(R) (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg), the First Once-Daily Single Tablet Regimen for Virologically Suppressed Adults With HIV-1 Infection
7. FDA Approves Cymbalta(R) for Maintenance Treatment of Major Depressive Disorder
8. Health Canada Approves ATRIPLA(R) (efavirenz 600 mg/emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg), the First Once-Daily Single Tablet Regimen for HIV
9. FDA Approves Lillys Osteoporosis Drug EVISTA(R) (raloxifene HCl) to Reduce The Risk of Invasive Breast Cancer in Two Populations of Postmenopausal Women
10. ChemoCentryx Initiates Clinical Trial of CCR1 Inhibitor CCX354
11. Velcura Therapeutics, Inc. Reports Successful Phase 1 Clinical Trial of Novel Bone Disease Therapy
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/5/2016)... -- Site Profile: --> ... Speech Recognition People, announced their latest primary healthcare case study where ... turnaround times and to save the practice money. Site ... Challenge: --> ,- Wirral CCG ,- VoicePower ... doctors ,- Wirral CCG ,- VoicePower client since 2013 ...
(Date:2/4/2016)... 2016  Edwards Lifesciences Corporation (NYSE: EW ), ... disease and critical care monitoring, announced today that it ... with Morgan Stanley & Co. LLC to repurchase $325 ... of the Company,s previously authorized program to repurchase up ... --> --> Under ...
(Date:2/4/2016)... , Feb. 4, 2016  SciClone Pharmaceuticals, Inc. ... it has entered into a settlement agreement with ... fully resolving the SEC,s investigation into possible violations ... the terms of the settlement agreement, SciClone has ... including disgorgement, pre-judgment interest and a penalty.  This ...
Breaking Medicine Technology:
(Date:2/5/2016)... , ... February 05, 2016 , ... ... the addition of micro-needling services in their Napa Valley office. The technique utilizes ... Plastic Surgery Associates, Dr. Canales and Dr. Furnas, are part of only a ...
(Date:2/5/2016)... ... , ... US Sports Camps , official operators of Nike Yoga Camps, ... yoga training. ChildLight Yoga Studio is centrally situated in the picturesque New England city ... Studio founder Lisa Flynn expresses her excitement, “We are thrilled to be partnering with ...
(Date:2/5/2016)... (PRWEB) , ... February 05, 2016 , ... Boar’s Head ... just in time for this weekend’s Big Game. Take the stress out of your ... will keep your guests happy at every stage of the game. , “The key ...
(Date:2/5/2016)... ... February 05, 2016 , ... Dr. Ben ... that it is now welcoming orthodontist, Dr. Amanda Cheng, to the practice. With ... of oral health care, including general dentistry, cosmetic treatments, periodontics, implant dentistry ...
(Date:2/5/2016)... ... February 05, 2016 , ... On ... Rare Diseases, a continuing medical education (CME) event presented by the Association for ... kind—and a first for ACCORD, whose mission is to provide education, tools, and ...
Breaking Medicine News(10 mins):