MEDICREA launches GRANVIA-C pre-IDE pilot trial for treatment of spinal pathologies

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 today 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 MRI 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.

• GRANVIA^®-C: already a proven success, just 9 months after its launch.

GRANVIA^®-C's substantial technological breakthrough was rewarded by its first CE marking from end-2009. The immediate marketing success of this prosthesis, launched in France, the United Kingdom and Benelux in the autumn of 2010, exceeded the Company's expectations: sales of GRANVIA^®-C accounted for 36% of the acceleration in activity of the MEDICREA Europe Francophone subsidiary and 27% of that of MEDICREA Technologies UK. Altogether, GRANVIA^®-C sales accounted for 5% of total Group sales in 2010. The marketing of GRANVIA^®-C is currently being extended, in accordance with the business plan. Since the start of 2011, GRANVIA^®-C is also available in Spain, Italy, Portugal and even Malaysia.

• Prosthetic cervical discs: One of the spinal implant market's most promising segments.

A relatively young market estimated at $150 million in 2010, the cervical disc prosthesis market is extremely dynamic, with an estimated 5-year annual growth rate of over 35% worldwide (compared to less than 3% for cervical cages) and over 44% for the United States alone. All in all, the global cervical disc prosthesis market is expected to exceed one billion dollars within the coming 6 or 7 years.

With over 6,000 procedures carried out in 2010 and a high unit price for prostheses, Germany represents over a half of the European market.

• 2011 outlook: A presence in new European countries and launch of a pre-IDE pilot trial with a view to initiating the approval process in the United States

The scope of the GRANVIA^®-C marketing plan reflects the Company's belief in the very substantial medical value of its prosthesis, which it considers to be unequalled today on the world market.

MEDICREA is currently preparing the marketing of GRANVIA^®-C in Germany within the framework of its launch in German-speaking countries, which is slated for early 2012. In the rest of the world, the implant is expected to be registered in a number of Latin American and Asian countries over the second half of this year.

Lastly, MEDICREA reaffirmed its ambition to obtain approval for the marketing of GRANVIA^®-C in the United States. To this aim, and in accordance with the process required by the FDA, MEDICREA has just launched a pre-IDE (Investigational Device Exemption) multicentre pilot trial that will involve 60 patients who will be monitored over a two-year period.

Denys Sournac, Chairman and CEO, comments: "We are very proud of the excellent reception given to GRANVIA^®-C by the surgical community. Highly innovative, GRANVIA^®-C highlights our engineering teams' unique ability to design very high value-added solutions whose technological innovation represents a clear break with the current offer. Given the excellent results recorded by GRANVIA^®-C just a few months after its marketing began, the ongoing growth in its sales since the start of 2011 and the marketing launch plan still to be implemented over the remainder of the year, we are able to confirm that we anticipate an increase in activity of around 40% over the year as a whole. At the same time, the success of GRANVIA^®-C is also helping boosting our Company's reputation around the world."

Source: MEDICREA