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FDA Greenlights Medicrea K-Jaws cervical compression staple.

The Medicrea Group, a Lyon, France-based firm specializing in surgical technologies for the treatment of spinal pathologies, has earned U.S. Food and Drug Administration (FDA) approval for its K-Jaws cervical compression staple for all cervical fixation indications carried out with interbody cages.

"Given this technology's highly innovative aspect and its unique design on the market, this approval process was the longest and most complex we have ever had to administer with the FDA, but we have now reached a decisive milestone," said Chairman/CEO Denys Sournac. "Following an examination of the product's clinical data--almost 5,000 units have already been implanted outside the United States since the product's launch in 2006--the FDA has approved our cervical staple in the U.S. market for the same indications as cervical plates. This approval has given rise to the creation of a new product code in the FDA's internal classification, giving the product a unique position on the spinal column fixation device market."

The U.S. cervical fixation market currently is estimated at $1.2 billion. In the United States, there are many cervical plate and standalone cage ranges. According to Medicrea, the K-Jaws implant is considerably less invasive and much quicker to insert than any cervical plate currently on the market. Its principle, which consists in fixing two adjacent vertebra by compression around a previously inserted interbody cage, results in stability thanks to the axial localization of the compression forces at the level of the spine's vertebral bodies.

In 2009, Medicrea signed a licensing pre-agreement for the exclusive use of this proprietary technology with a major American partner regarding the marketing of the K-Jaws in the United States and, as an option, the rest of the world. Given the significantly longer-than-expected time taken to obtain FDA approval for the K-Jaws, Medicrea is no longer bound by the agreement.

"We are therefore free to openly negotiate again, which is particularly fitting given that since then other companies had indicated their interest in distributing the product subject to the company obtaining FDA approval in the United States," added Sournac. "Furthermore, our American distribution subsidiary has significantly expanded, and at this stage we don't rule out structuring this subsidiary to directly address the 5,000 American surgeons who could potentially use The K-Jaws with our own teams, backed by a network of regional agents. Over the coming quarters, we will, therefore, assess the various options open to us, external or internal, to market and promote our technology."

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Title Annotation:Washington Roundup
Publication:Orthopedic Design & Technology
Date:Sep 1, 2014
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