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Wednesday, August 3, 2011

MEDICREA'S GRANVIA®-C: Launch of a Pre-Ide Pilot Trial With a View to Initiating the Approval Process in the United States

MEDICREAJune 30, 2011 - LYON, France -
  • Worldwide (outside of USA): Marketing schedule reaffirmed and launch in 6 new countries over the second half of the year
The MEDICREA Group (FR0004178572-ALMED) (Paris:ALMED), listed on Alternext by NYSE Euronext Paris, a medical device company specialized in the development of innovative surgical technologies for the treatment of spinal pathologies, reaffirmed its ambitious marketing schedule for GRANVIA®-C, its next-generation cervical disc prosthesis, and also announced the launch of a pre-IDE pilot trial with a view to initiating the approval process in the United States.

  • GRANVIA®-C: a patented technological feat.
A flagship product of MEDICREA’s Research & Development laboratories, GRANVIA®-C is the first cervical disc prosthesis that allows “natural” physiological movement and extreme longevity, thus providing patients with very similar functionalities to those of healthy cervical discs.
In terms of biomechanics, cervical mobility is offered by 6 degrees of freedom, through differentiated centers of rotation and a patented mobile core with an integrated shock absorber system. In terms of material, the prosthesis’ high-tech ceramic design allows both a reduction in friction and optimal wear and fatigue resistance, giving the prosthesis a very long lifespan. Furthermore, using ceramic also ensures that it is perfectly MRI1 compatible, unlike the cervical prostheses currently on the market, whose metallic components result in MRI artifacts incompatible with visualizing the spinal cord, discs and soft tissue around the zone concerned.

Matching MEDICREA’s development philosophy of “innovating for next-generation vertebral implantology”, the GRANVIA®-C prosthesis is supplied with a disposable sterilized inserter. This has a number of advantages: it is easy to insert so saves significant time, and therefore enhances patient wellbeing and lowers hospital costs. Furthermore, this also minimizes the risk of infection and optimizes traceability, resulting in an unparalleled improvement in safety conditions...

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...About MEDICREA :

MEDICREA specializes in the design, development, manufacture and distribution of orthopedic implants dedicated to spinal surgery.
In a $9 billion market, MEDICREA is a very dynamic small to medium-sized business of 100 employees with unique innovation capabilities. The Company enjoys an excellent and ever-improving reputation and develops unique relationships with the most visionary and creative spine surgeons in France, the UK, and the USA. Products developed and patented by MEDICREA provide neurosurgeons and orthopedic surgeons specialized in the spine with new and less-invasive surgical solutions that are faster and easier to implement than traditional techniques. The Group’s headquarters are based in Lyon, France, and it also has a manufacturing facility located in La Rochelle as well as three distribution subsidiaries in the USA, the UK and France... MEDICREA's Press Releases - Communiqués de presse de MEDICREA -