Navigation Links
US HIFU Receives Unanimous Approval to Continue the Clinical Investigation of High Intensity Focused Ultrasound (HIFU) for Treatment of Prostate Cancer
Date:5/3/2010

CHARLOTTE, N.C., May 3 /PRNewswire/ -- US HIFU, a worldwide leader in the development, distribution and use of minimally invasive high intensity focused ultrasound (HIFU) technologies, received unanimous approval from its Data and Safety Monitoring Board (DSMB) to continue enrollment in its FDA-approved prospective clinical trial investigating the use of high intensity focused ultrasound (HIFU) technology delivered via the Sonablate® 500 ("Sonablate HIFU") medical device to treat localized primary prostate cancer. US HIFU intends to submit the completed data to the FDA in support of its request for commercial approval to treat primary prostate cancer in the U.S.

Sonablate HIFU destroys diseased prostatic tissue with extreme heat generated from focused ultrasound waves. The ultrasound energy is delivered in rapid-fire succession to targeted tissue throughout the gland. The tissue at each target is destroyed while surrounding tissue remains unharmed.

The DSMB, an independent group of experts that monitors clinical data to ensure patient safety during any clinical trial process, made no changes to the existing criteria following its review from the initial cohort of enrolled patients.

"This is quite an exciting milestone in this process. Unanimous approval from the board reaffirms that we are right on track with our study," said US HIFU CEO Steve Puckett, Jr. "I am confident that we will complete the trial and certainly remain hopeful that this minimally invasive prostate cancer treatment will be available in the U.S. in the near future."

Additionally, US HIFU continues active enrollment in the FDA-approved prospective clinical trial investigating Sonablate HIFU for the treatment of recurrent prostate cancer.  As with the primary prostate cancer clinical trial, US HIFU intends to submit this completed trial data to the FDA in support of its request for commercial approval to treat recurrent prostate cancer in the U.S.

"We are proud to have 18 well-known and respected institutions on board as our current trial sites," said Dawn Rice, director of clinical affairs. "We are working diligently to round out the list of sites as well as to enroll additional participants in both the recurrent and primary trial."

For additional clinical trial information, including participation criteria for either trial, please contact the director of clinical affairs at (678) 896-1575 or dawnrice@ushifu.com.

About USHIFU US HIFU (USHIFU, LLC), a privately held healthcare company, is a world leader in minimally invasive high intensity focused ultrasound (HIFU) technologies. US HIFU manufactures the Sonablate® 500 medical device and is focused currently on treating primary and recurrent prostate cancer using Sonablate® HIFU. The company is engaged in ongoing research for technological advancements for the Sonablate® system or other ultrasound applications.

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 by Focus Surgery, Inc. and is manufactured in part by Misonix, Inc. (Nasdaq: MSON), which also holds distribution rights in Europe. Takai Hospital Supply Ltd. distributes the Sonablate® 500 in Southeast Asia. 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
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Ethicon Endo-Surgery SEDASYS(R) System Receives Regulatory Approval in Canada and CE Mark in European Union
2. EndoChoice(R) Receives 510K Clearance for its BONASTENT(R) Esophageal and Biliary Stent Platforms
3. Fenwal Receives FDA Clearance for Amicus(R) Separator With Wireless Connectivity
4. Mylan Receives Approval for Generic Version of Flomax(R)
5. BioMedix Receives Clinical Approval for TRAKnet Software
6. Shire Receives INTUNIV(TM) Paragraph IV Notice Letter From Anchen
7. Flexuspine Receives FDA Conditional Approval to Begin a Feasibility Study of Its FSU (Functional Spinal Unit) Total Spine Arthroplasty System in the United States
8. Palatin Technologies, Inc. Receives $2.5 Million from AstraZeneca
9. ATS Medical Receives Approval to Commercialize the ATS Simulus Annuloplasty Products in Canada
10. Actavis Receives Approval of Alprazolam ODT in the U.S.
11. Epeius Biotechnologies Receives Notice of Patent Allowance for Tumor-Targeted Cancer Vaccines
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/27/2017)... NEW YORK , Sept. 27, 2017  DarioHealth Corp. ... big data solutions, today announced that its MyDario product is expected to ... TV listings for when The Dr. Oz Show airs in your area: ... The nine-time Emmy award-winning, ... ...
(Date:9/23/2017)... -- Janssen Biotech, Inc. (Janssen) announced today that it ... Food and Drug Administration (FDA) for the Biologics License ... of moderately to severely active rheumatoid arthritis (RA). The ... to further evaluate the safety of sirukumab in the ... "We are disappointed by ...
(Date:9/19/2017)... medical device company developing a non-invasive, robotically assisted, platform therapy that uses pulsed sound energy ... ... Jim Bertolina, PhD ... Tom Tefft ... executive Josh Stopek , PhD, who has led R&D and business development teams at ...
Breaking Medicine Technology:
(Date:10/13/2017)... ... October 13, 2017 , ... Global Healthcare Management’s 4th Annual ... in Milford, NJ. This free event, sponsored by Global Healthcare Management’s CEO, Jon ... fun run is geared towards children of all ages; it is a non-competitive, non-timed ...
(Date:10/13/2017)... (PRWEB) , ... October 13, 2017 , ... ... will be giving viewers the lowdown on sciatica in a new episode of ... that focuses on current events and innovation and investigates each subject in-depth with ...
(Date:10/13/2017)... ... October 13, 2017 , ... “The Journey: From the Mountains to the ... save lost souls in the Philippines. “The Journey: From the Mountains to the Mission ... of the Bible. She has taught all ages and currently teaches a class of ...
(Date:10/12/2017)... ... October 12, 2017 , ... First ... compliance program management, will showcase a range of technology and learning solutions at ... (NCAL) Convention and Expo to be held October 14–18, 2017 at the Mandalay ...
(Date:10/12/2017)... Orleans, LA (PRWEB) , ... October 12, 2017 , ... ... centers in the U.S., announced today its plans to open a flagship location in ... will occupy the former Rooms To Go store next to Office Depot in the ...
Breaking Medicine News(10 mins):