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

   

Medical Carbon Research Institute's On-X(R) Prosthetic Heart Valve Approved In Japan; On-X Valve To Be Introduced At The Japan Society Of Cardiovascular Surgery


10/19/2005 5:12:47 PM

AUSTIN, Texas, Feb. 22 /PRNewswire/ -- Medical Carbon Research Institute L.L.C. (MCRI), today announced the approval of the On-X Prosthetic Heart Valve by the Japanese Ministry of Health, Labor and Welfare (MHLW). Japan is the second largest market in the world for mechanical valves. The On-X valve introduction will begin on February 23, during the 35th Annual Meeting of the Japanese Society for Cardiovascular Surgery in Hamamatsu, Japan. The introduction represents a joint effort by MCRI and Paramedic Co., LTD. of Tokyo, who will provide exclusive representation for the On-X valve throughout Japan. Approval by MHLW was achieved through collaboration between regulatory departments of MCRI and Paramedic and was based on clinical trials conducted in the U.S. and Europe, the first valve approval to be granted in Japan based entirely on overseas clinical data.

"It is difficult to overstate the importance of this regulatory approval to MCRI. The opening of this major new market for the On-X valve represents a significant revenue opportunity for our company. In combination with the 60% growth experienced in On-X valve sales in 2004, the approval will provide MCRI with an opportunity for continued growth of world wide market share for this advanced prosthesis," stated Clyde Baker, President of MCRI. "We are gratified by the rapid acceptance of the On-X valve by leading institutions in the United States and believe that Japanese surgeons will be particularly interested in technical differences of the On-X valve and will desire that their patients benefit from reduced valve related complications and improved hemodynamic performance documented with the use of the On-X valve."

The On-X valve is the product of a technology break-through in carbon materials manufacturing and heart valve design. These technologies provide a 100% pure carbon surface and help create a turbulent free blood flow through the valve. The result is a valve with morbid event occurrence so reduced as to justify a study with selected aortic valve replacement patients using one aspirin a day as the only anticoagulation. This study has just passed the one-year anniversary of its initiation, a milestone untouched by competitive mechanical valves.

About Cardiovascular Disease and Heart Valve Replacement

Cardiovascular disease is the number one cause of death worldwide. Heart Disease and Stroke Statistics-2005 Update, published by the American Heart Association, states that over 700,000 people undergo open-heart surgery each year, of which approximately 93,000 surgeries are to treat malfunctioning or diseased heart valves.

About MCRI

Medical Carbon Research Institute (MCRI) develops heart valve replacements that significantly improve the quality of life of patients. Jack Bokros, Ph.D., and his associates founded MCRI in 1994 to further advance prosthetic heart valve technology by capitalizing on their new form of pyrolytic carbon. The company gained FDA approval for the On-X aortic valve in 2001 and for the On-X mitral valve in 2002.

MCRI also provides OEM services to other medical products companies utilizing its patented pyrolytic carbon for use as orthopedic joint and spine prosthetic implants.

MCRI is headquartered in Austin, Texas, and maintains a wholly owned subsidiary, MCRI Deutschland GmbH, in Hannover, Germany. MCRI is a privately held company whose operations have to date been funded through equity and debt investments by its founders, strategic investors and a capital fund. More information is located at http://www.mcritx.com/ or at http://www.onxvalves.com/ .

For more information about MCRI or the On-X Prosthetic Heart Valve please contact Clyde Baker, President at 512-339-8000 ext. 269 or at cbaker@mcritx.com .

In Japan please contact Paramedic Co. Ltd (Tel) 03-3582-2222 or paramedic@pop11odn.ne.jp.

MCRI and On-X are registered trademarks of Medical Carbon Research Institute L.L.C.

Contact: Clyde Baker 512-339-8000, ext. 269 cbaker@mcritx.com

Medical Carbon Research Institute L.L.C.

CONTACT: Clyde Baker of Medical Carbon Research Institute L.L.C.,+1-512-339-8000, ext. 269, or cbaker@mcritx.com ; or Paramedic Co. Ltd,+03-3582-2222 or paramedic@pop11odn.ne.jp



Read at BioSpace.com

   

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