French spinal device company The MEDICREA Group has announced that the FDA has approved the K-JAWS® Cervical Compression Staple for all cervical fixation indications carried out with interbody cages.
The U.S. cervical fixation market, estimated at $1.2 billion is occupied by relatively homogenous cervical plate and standalone cage ranges that differ little from each other. Medicrea is aiming to upset the applecart with its K-JAWS® implant, which it says is considerably less invasive and much quicker to insert than any cervical plate currently on the market. The principle involves fixing two adjacent vertebra by compression around a previously-inserted interbody cage, resulting in claimed exceptional stability thanks to the axial localization of the compression forces, at the level of the spine’s vertebral bodies.
As far as commercializing the device, Medicrea tells us that back in 2009 it entered into a licensing pre-agreement for the exclusive use of this proprietary technology with a major American partner, including 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 this agreement so will presumably be shortly confirming new distribution plans.
“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,” says Denys SOURNAC, Chairman and CEO of MEDICREA. “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.”
On the termination of the previously existing commercial agreement Sournac says; “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. 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.”
Source: Medicrea Group, Business Wire