|[August 01, 2014]
MEDICREA's K-JAWS® Obtains FDA Approval for Its Marketing in the United States
LYON, France --(Business Wire)--
The MEDICREA Group: (Paris:ALMED) (FR0004178572-ALMED), which
specializes in the development of innovative surgical technologies for
the treatment of spinal pathologies and is listed on Alternext - Paris,
announces that the FDA has approved the K-JAWS® Cervical Compression
Staple for all cervical fixation indications carried out with interbody
MEDICREA has just obtained FDA approval to market its K-JAWS®
Cervical Compression Staple in the United States "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."
This breakthrough innovation targets an American cervical fixation
market estimated at $1.2 billion that is today occupied by relatively
homogenous cervical plate andstandalone cage ranges that differ little
from each other.
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
exceptional 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 KJAWS®,
MEDICREA is no longer bound by this 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. 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."
concludes Denys SOURNAC.
Next publication: 2014 first-half
results and third-quarter sales: October 14th 2014, after
ABOUT MEDICREA (www.medicrea.com)
MEDICREA specializes in the design, development, manufacture, and
distribution of orthopedic implants dedicated to spinal surgery. In a
$10 billion market, MEDICREA is a very dynamic small to medium-sized
business of 130 employees with unique innovation capabilities. The
Company enjoys an excellent and ever-improving reputation and develops
unique relationships with the most visionary and creative spine surgeons
in France, the UK, and the USA. Products developed and patented by
MEDICREA provide neurosurgeons and orthopedic surgeons specializing in
the spine with new and less-invasive surgical solutions that are faster
and easier to implement than traditional techniques. The Group's
headquarters are based near Lyon, France, and it also has a
manufacturing facility for surgical instruments and implants located in
La Rochelle as well as three distribution subsidiaries in the USA, the
UK, and France.
MEDICREA is listed on ALTERNEXT Paris
ISIN: FR 0004178572
- Ticker: ALMED
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