BioSpace.com

Biotech and Pharmaceutical
News & Jobs
Search the Site
 
   
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
Browse Biotech 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
  US Device
Europe
Asia

DIVERSITY

INVESTOR
Market Summary
News
IPOs

PROFILES
Company Profiles

START UPS
Companies
Events

INTELLIGENCE
Research Store

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

 News | News By Subject | News by Disease News By Date | Search News
eNewsletter Signup
Miles
Km80.5

   

Bioness Inc. Initiates Study of Neuromodulation System for Chronic Peripheral Nerve Pain


4/9/2012 9:10:56 AM

VALENCIA, Calif., April 9, 2012 /PRNewswire/ -- Bioness Inc. today announced the initiation of a study to evaluate the safety and effectiveness of the company's StimRouter Neuromodulation System for those suffering from chronic peripheral nerve pain. This prospective, multi-center, randomized, double-blinded, partial crossover study will enroll 126 patients at up to 10 study sites throughout the United States. About 20 million individuals in the United States suffer from chronic peripheral nerve pain, and current treatments include non-localized therapies such as spinal cord stimulation and the use of systemic pain medication.

"Chronic peripheral nerve pain can have a dramatic impact on a patient's quality of life, and historically we have had few treatment options other than the use of pharmaceutical therapy most often narcotics, which affect the whole body and have many undesirable side-effects," said Timothy Deer, MD, the study's medical monitor and pain management specialist at The Center for Pain Relief at Saint Francis Hospital in Charleston, West Virginia. "The StimRouter could potentially provide - for the first time - a non-pharmaceutical treatment option that can be targeted directly to the pain site for more focused pain relief. The results of this study could have a significant impact on the way we treat patients with peripheral nerve pain."

The StimRouter System is designed to relieve chronic neuropathic pain of peripheral origin. The device consists of an implanted lead that delivers low-level electrical impulses directly to the nerve that carries the pain signal. The External Pulse Transmitter (EPT), worn outside the body, sends electrical signals through the skin to the implanted lead. The EPT has the capability of storing stimulation programs to provide patients with a variety of treatment options depending on their activity or level of pain.

"At Bioness, we have always been dedicated to developing technologies that help patients improve their quality of life despite debilitating conditions," said Thomas G. Fogarty, President and CEO of Bioness. "The results of this study will help improve our understanding of how to most effectively treat chronic peripheral pain while improving patient care, potentially enabling us to help a greater number of patients."

The study, "Prospective, Multi-Center, Randomized, Double-Blinded, Partial Crossover Study to Assess the Safety and Efficacy of the Bioness® StimRouter Neuromodulation System in the Treatment for Patients with Chronic Pain of Peripheral Nerve Origin," is expected to last for 30 months, with each study participant receiving treatment and evaluation for a total of 13 months. The study will evaluate the effect of the system on patients' overall pain, as well as changes in pain medication, quality of life, patient impression of improvement with treatment, change in worst pain, interference of pain with physical and emotional functioning, patient satisfaction and long-term safety.

For more information about this study contact Cheryl Doriot, Clinical Study Manager, at Bioness at Cheryl.Doriot@bioness.com.

About Bioness Inc.
Bioness provides neuromodulation technologies that help improve lives and restore function for those living with neurological deficits and peripheral pain. The company develops, manufactures and markets innovative neuromodulation products that help individuals with central nervous system disorders such as stroke, multiple sclerosis, spinal cord injury and traumatic brain injury regain movement in affected limbs. The L300® Foot Drop System, L300® Plus System, H200® Hand Rehabilitation System, and H200® Wireless Hand Rehabilitation System are cleared for use by the Food and Drug Administration and are designed to help patients achieve new levels of physical independence and productivity. Individual results vary. Consult with a qualified physician to find out if these products are right for you. Additional information about Bioness can be found at www.bioness.com.

L300®, L300® Plus, H200®, and Bioness® are trademarks of Bioness Inc. | www.bioness.com | Rx Only

Media Contact:

Wendy Ryan/Courtney Conery
Schwartz MSL
781-684-0770
bioness@SchwartzMSL.com

SOURCE Bioness Inc.



Read at BioSpace.com

   

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