The US Food and Drug Administration (FDA) has granted marketing approval for France-based Medicrea Group’s K-JAWS cervical compression staple for all cervical fixation indications carried out with interbody cages.
The French firm specialises in the development of innovative surgical technologies for treatment of spinal pathologies.
Compared with currently available cervical plate on the market, the K-JAWS implant is less invasive and much quicker to insert, according to the company.
Medicrea chairman and CEO Denys Sournac said: "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 every had to administer with the FDA, but we have now reached a decisive milestone.
"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 US 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 company had signed a licensing pre-agreement in 2009 for the exclusive use of this proprietary technology with a major American partner, regarding the marketing of the K-JAWS in the US and, as an option, the rest of the world.
Denys SOURNAC said: "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 US.
"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."