MEDICREA has acquired all intellectual property related to the compressive mini-frame technology used in its C-JAWS® spinal implant. The transaction was concluded for €1.0 million in cash. This acquisition includes five registered US patents and one European registered patent covering the fifteen major European States, as well as an application for registration for two patents in the USA, one patent in Europe, and one patent in China and Hong Kong.
In collaboration with leading French spine surgeons, MEDICREA began development of the C-JAWS® in 2004 using licensed patents. This invention, as well as its subsequent versions, surgical instruments, and current developments, is now a technology fully owned by MEDICREA.
The C-JAWS® has been approved in Europe as a cervical fixation system and in the United States as an interbody cage buttress. There is no other implantable medical device like C-JAWS® on the cervical fixation market, which was estimated at $850 million in 2007, with the United States representing nearly 85%. In conjunction with the IMPIX-C® cervical interbody cage, the combination product targets a market segment estimated at $1.2 billion.
Through its effectiveness (with ongoing clinical studies), extreme ease of use, and rapid implantation in the patient during surgery, this implant marks a major innovation over the traditional technique of cervical fixation. C-JAWS® is the only implant on the market which allows spinal stabilization around the previously-inserted interbody cage, thanks to a unique compression effect.
In just a few minutes, the surgeon is able to fix, insert, and compress the C-JAWS® implant, all with a single surgical instrument, by simple distraction of its diamond-shaped titanium structure. This contrasts with an operating time of 30-60 minutes for the traditional fixation technique, with cervical plate and screws. The time saved in the operating room represents significant progress for the patient, and also translates to greater availability of the surgeon for additional operations.
The very small size of C-JAWS® places it in the "mini-invasive" category, in line with the growing number of miniature surgical implants. This is a fundamental trend, visible in all new product developments at MEDICREA.
Several clinical trials, retrospective and prospective, involving nearly two hundred patients are currently under way in some major European hospitals. These trials aim to verify the effectiveness and the safety of C-JAWS®. The intermediate results of the principal multicenter prospective trial, which involves 83 patients, have so far been excellent. They emphasize the rapidity of bone fusion as well as patient satisfaction. 98% of patients treated with the C-JAWS® and the IMPIX-C® cage and monitored for six months declare that they are satisfied or very satisfied with the outcome of the procedure: Improvement of Neck Disability Index (NDI) from 20.6 +/- 8.8 at baseline to 10.1+/-7.9 after 6 months and pain relief (Visual Analogic Scale) from de 6.1 +/- 2.8 at baseline to 2.6+/- 2.1 after 6 months. The definitive results of this clinical trial will be made public in 2009, and should contribute to a strong rise in C-JAWS® and IMPIX-C® cage sales effective from the second half of 2009.
MEDICREA also announces the CE marking certification for its K-JAWS™ Cervical, an implant combination product composed of a C-JAWS® and an IMPIX-C® cervical cage, now approved as a single product in Europe. MEDICREA expects to have approval in the United States by the end of 2008. The FDA is currently reviewing the product file.
Denys Sournac, President and CEO of MEDICREA Group says, "Since MEDICREA received CE marking certification in 2006, nearly two thousand patients have undergone C-JAWS® surgeries. We estimate that C-JAWS® sales will increase significantly in 2009 with publication of the results of several clinical trials currently underway and the FDA approval of K-JAWS™ in the United States. Approximately six thousand American surgeons are potential users of this product. Since March 2007, three hundred thirty patients have been operated with C-JAWS® in the USA by some thirty surgeons. Our goal is to have three hundred US surgeons who are regular K-JAWS™ Cervical users in the next 18 to 24 months. We are not excluding the possibility of formalizing a structural partnership agreement with one of the leading orthopedic corporation in the United States, which would give us an even bigger share in the cervical-fixation market"
The acquisition of all intellectual property pertaining to this technology marks a major step for MEDICREA, whose C-JAWS® and now K-JAWS™ are key elements in Group development. This acquisition strengthens the strategic value of MEDICREA's R&D, with innovation being one of the Group's main drivers of long-term growth.
MEDICREA specializes in the design, development, manufacture and distribution of implants and instruments dedicated to spinal surgery. In a $6B market, which is growing at a rate of 20% per annum, MEDICREA is a dynamic company demonstrating innovative capabilities that differentiate it from competitors. MEDICREA enjoys an excellent reputation and benefits from unique relationships with highly skilled spine surgeons. Products developed and patented by MEDICREA provide surgeons with new, less invasive surgical solutions, which are faster and easier to implement than traditional techniques. The Group operates from its headquarters based in Lyon, France with a manufacturing facility located in La Rochelle, France and three distribution subsidiaries in the USA, the UK and in France.
ISIN code: FR 0004178572
Alternext Code: ALMED
More information at www.medicrea.com
Denys Sournac, President and Chief Executive Officer
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Fabrice Kilfiger, Chief Financial Officer
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Analysts and Investor Relations
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