Published on June 30, 2011 at 5:51 AM
- 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."