BioSpace Collaborative

Academic/Biomedical Research
News & Jobs
Biotechnology and Pharmaceutical Channel Medical Device and Diagnostics Channel Clinical Research Channel BioSpace Collaborative    Job Seekers:  Register | Login          Employers:  Register | Login  

NEWSLETTERS
Free Newsletters
Archive
My Subscriptions

NEWS
News by Subject
News by Disease
News by Date
PLoS
Search News
Post Your News
JoVE

CAREER NETWORK
Job Seeker Login
Most Recent Jobs
Search Jobs
Post Resume
Career Fairs
Career Resources
For Employers

HOTBEDS
Regional News
US & Canada
  Biotech Bay
  Biotech Beach
  Genetown
  Pharm Country
  BioCapital
  BioMidwest
  Bio NC
  BioForest
  Southern Pharm
  BioCanada East
  C2C Services & Suppliers™
Europe
Asia

DIVERSITY

PROFILES
Company Profiles

INTELLIGENCE
Research Store

INDUSTRY EVENTS
Research Events
Post an Event
RESOURCES
Real Estate
Business Opportunities

 News | News By Subject | News by Disease News By Date | Search News
Get Our Industry eNewsletter FREE email:    
   

Focus Surgery Inc. Receives FDA Approval For A Phase III Clinical Study Using HIFU With The Sonablate(R) 500 For The Treatment Of Prostate Cancer


8/9/2006 10:22:45 AM

INDIANAPOLIS, Aug. 9 /PRNewswire/ -- Focus Surgery, Inc. the developer of the Sonablate(R) 500, announced today that the Food and Drug Administration (FDA) granted the Sonablate(R) 500 a provisional Investigational Device Exemption (IDE), which will allow the device to be used in a multicenter clinical study to collect safety and efficacy data for final FDA approval. The clinical study will use High Intensity Focused Ultrasound (HIFU) for the treatment of low risk, localized (T1c/T2a) prostate cancer with the Sonablate(R) 500. The study will enroll approximately 466 subjects at 24 institutions.

"We are excited by the news from the FDA and by the continued progress of the Sonablate(R) 500 as demonstrated by our successful completion of the FDA approved pilot study. The HIFU technology utilized by the Sonablate(R) 500 was developed in collaboration with the Indiana University School of Medicine which is one of the planned study sites," said Narendra T. Sanghvi, CEO and President of FSI. "The ability to proceed with the FDA pivotal study is the most significant milestone achieved by Focus Surgery to date. In collaboration with USHIFU, LLC we will be announcing details on the specific site locations in the next 90 to 120 days."

HIFU is a targeted, precise treatment that uses sound waves to rapidly heat and kill targeted tissue while sparing the surrounding tissue. The Sonablate(R) 500-HIFU device uses real-time ultrasound image guidance for the treatment of prostate cancer. This non-invasive procedure is performed on an out-patient basis and international studies suggest a substantial reduction in common side effects such as impotence and incontinence.

Although the Sonablate(R) 500 system is still in clinical trials in the United States, it is already approved in Canada, Europe and Asia. The device is manufactured by Misonix, Inc. who also holds distribution rights in Europe. Takai Hospital Supply, Inc. and THS International, Inc. distribute the Sonablate(R) 500 in Southeast Asian and Middle Eastern countries. In North and South America and South Africa the distributor is USHIFU, LLC, who is also contracted to perform the approved US clinical studies.

Currently, HIFU with the Sonablate(R) 500 is available at over 100 clinical centers for the treatment of prostate disease and it is distributed within 18 countries worldwide. Additional information is available at http://www.focus-surgery.com.

Focus Surgery, Inc.

CONTACT: Megan Porter of Focus Surgery, Inc., +1-317-541-1580, ormporter@focus-surgery.com


Read at BioSpace.com


   

ADD TO DEL.ICIO.US    ADD TO DIGG    ADD TO FURL    ADD TO STUMBLEUPON    ADD TO TECHNORATI FAVORITES
 

//-->