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

   

FzioMed Inc. Receives Approval for Oxiplex® in Russia


1/22/2013 7:20:01 AM

SAN LUIS OBISPO, Calif.--(BUSINESS WIRE)-- FzioMed, a privately held medical device company based in San Luis Obispo, CA., is pleased to announce the approval of Oxiplex in Russia. Oxiplex is an absorbable, clear, viscoelastic gel that is applied during lumbar spine surgery immediately prior to wound closure. Based on four studies involving more than 500 patients, and nearly 10 years of commercial use benefitting more than 300,000 patients outside the U.S., Oxiplex has proven itself to be an effective surgical adjuvant that significantly reduces the effects of Failed Back Surgery Syndrome (FBSS) such as leg pain and neurological symptoms following surgery. Available in nearly 70 countries, including those in the European Union, Australia, Canada, Brazil, Mexico, South Korea and now Russia.

After a rigorous process in the largest country in the world, the Roszdravnadzor regulatory body has approved the sale of Oxiplex to physicians so that patients can experience the well-documented benefits of this adjunct to lumbar spine surgery.

“Russia presents a huge opportunity for FzioMed to expand the availability of Oxiplex to more than 140 million people, many of whom experience the same issues as we do with back and leg pain due to disc herniation,” said John Krelle, President and CEO of FzioMed. “Russian patients may now receive the added benefits of lower pain scores and reduced reoperation rates after lumbar surgery that peer reviewed published literature and more than 300,000 patients worldwide have demonstrated for more than a decade.”

Oxiplex is not yet approved in the United States despite having demonstrated safety and effectiveness in clinical studies involving more than 500 patients. A Citizen Petition under 21 CFR 10.33 is still under review by FDA.

About FzioMed

FzioMed is a privately held medical device company founded in 1996. The company develops, manufactures and commercializes absorbable surgical biomaterials based on its patented polymer science. FzioMed adhesion barriers are used in many surgical applications including spine, orthopedics, hand, tendon, peripheral nerve, gynecology and general surgery. Its spine gel is the #1 adhesion barrier gel for spine surgery worldwide and is distributed by Medtronic, DePuy and other independent distributors. For more information, please visit www.fziomed.com.

Contact:

FzioMed, Inc.

John Krelle, CEO and President

805-546-0610



Read at BioSpace.com

   

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