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

   

ORTHOCON Receives CE Mark and Health Canada Medical Device License for HEMASORB(R)


4/21/2011 6:52:20 AM

IRVINGTON, N.Y., April 21, 2011 /PRNewswire/ -- ORTHOCON, Inc., a privately-held therapeutic device company, today announced that DEKRA and Health Canada have cleared its HEMASORB Absorbable Bone Hemostat Matrix for clinical use and sale in Europe and Canada.

HEMASORB is a ready-to-use, biocompatible, water resistant, and absorbable putty designed to rapidly stop bleeding when applied to damaged or cut bone. Control of bleeding from cut bone is a problem in many operative procedures including spine, orthopedic, cardiac, and craniomaxillofacial surgeries. Excessive bleeding during surgery may impair the surgeon's view of the operative field, may result in the need for blood transfusions, and may be associated with post-operative complications. ORTHOCON estimates that over 3.5 million patients undergoing surgeries in the United States, Europe, and Canada each year could benefit from the intra-operative use of HEMASORB.

"We are pleased that HEMASORB has been cleared for clinical use and sale in Europe and Canada," said John J. Pacifico, President and Chief Executive Officer of ORTHOCON. "We are confident HEMASORB will provide surgeons in Europe and Canada with an innovative and cost-effective tool to assist in their management of intra-operative bone bleeding, and we fully expect HEMASORB to become the standard of care for bone hemostasis."

HEMASORB, previously cleared by the Food and Drug Administration (FDA) via the 510(k) premarket notification process, was first introduced in the U.S. in 2010. The product has been approved for sale at leading hospitals throughout the United States and is used successfully by hundreds of surgeons. ORTHOCON will continue to focus its efforts on increasing adoption of HEMASORB in the U.S. and is actively pursuing product distribution partnerships in Europe and Canada to ensure HEMASORB becomes widely available to surgical patients in these markets.

About ORTHOCON

Founded in 2005, ORTHOCON develops, manufactures, markets, and sells implantable products that stop bone bleeding. ORTHOCON's technology platform is also being developed to enable controlled, local drug delivery to the treatment site.

ORTHOCON is funded by leading international venture capital investment firms. The company occupies 8,000 square feet at its state-of-the-art facility in Irvington, New York. For more information, please visit www.orthocon.com.

Read at BioSpace.com

   

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