SPINEART ANNOUNCES THE PUBLICATION OF CLINICAL DATA FOR ITS BAGUERA®C ARTIFICAL CERVICAL DISC PROSTHESIS
Spineart announces the publication of Arthroplasty with the Baguera®C Cervical Disc Prosthesis: A Review of the Scientific Background, Clinical and Radiographic Evidences(1) in the Journal of Spine & Neurosurgery
The authors discussed peer-reviewed or published literature studying the Baguera®C cervical disc prosthesis clinical and radiological results. The goal of the review was to evaluate the clinical outcomes of cervical disc replacement with Baguera®C and discuss these in comparison with the results of other prosthesis in the literature.
The review reported the results of three case series evaluating the safety and performance of Baguera®C over an observational period of two years.
The authors concluded that cervical disc replacement with Baguera®C is a safe and effective procedure for the treatment of radiculopathy due to soft disc herniation and/or moderate uncarthrosis on 1 or 2 levels. The results showed that Baguera®C had limited or no influence on the biomechanics of adjacent levels. The rate of heterotopic ossification tended to be lower compared to other cervical disc prosthesis published in the literature.
So far, more than 15’000 BAGUERA®C disc prosthesis have been implanted worldwide. The first surgery was performed in France in January 2007.24
SPINEART SECURED A EUR 30 MILLION INVESTMENT FROM GIMV
Spineart today announces that it secured a EUR 30 million investment from Gimv[1]. These proceeds will be used to reinforce the company’s sales organization and processes, for further geographical expansion in selective markets such as the US and Europe, as well as for continued development of innovative and disruptive products.
“Gimv is the partner we need to reach the next level. Its Health & Care team’s experience in accompanying fast growing companies will help to reach Spineart’s ambitious goals. Therefore, we are very pleased to have them on board and are excited to write together the next chapter in Spineart’s history,” said Jérôme Levieux and Stéphane Mugnier-Jabob, co-founders and co-CEOs of Spineart.
Gimv is an investment company with over three decades experience in private equity and venture capital, listed on Euronext Brussels. The company identifies entrepreneurial and innovative companies with high-growth potential and supports them in their transformation into market leaders, and currently manages around 1.8 billion EUR of investments.
Peter Byloos, Partner in Gimv’s Health & Care team, comments: “Spine surgery is an attractive global market offering plenty of room for challengers such as Spineart. Next to its broad product portfolio and recognized European brand, the company differentiates itself by a strong focus on product innovation and full R&D pipeline. We look forward to share our expertise in the field of Building Companies and International Operations with Spineart’s experienced and committed leadership team”.
More information on Gimv can be found on www.gimv.com.
[1] Joint-investment by Gimv and the Gimv Health & Care Fund
SPINEART SA TO START BUSINESS IN AUSTRALIA THROUGH SPINEART AUSTRALIA PTY LTD
Spineart SA, announces today, that they will market directly its product range in Australia through the newly established entity Spineart Australia Pty Ltd.
Spineart Australia will cooperate with Sportmedtech, an Australian incorporated company located in Melbourne, VIC.
Sportmedtech team has over 10 years of experience in spine & orthobiologics in Australia with established connections to local surgeons and will be instrumental to promote Spineart’s comprehensive portfolio in the fields of MIS surgery, motion preservations, fusion, biologics and fracture treatment.
The Australian spine market, valued at approx. USD 230 million is presenting a growth opportunity for Spineart SA.
Spineart’s range associated to Sportmedtech’s connections and market knowledge is the right association to success in the challenging Australia market place.
SPINEART RECEIVES CLEARANCE FROM THE FDA TO MARKET ITS TI-LIFE TECHNOLOGY 3D TITANIUM INTERBODY DEVICES
Spineart is pleased to announce that it has received 510(k) clearance from the FDA to market its new JULIET®Ti lumbar interbody systems in the United States.
The JULIET®Ti PO, OL and TL interbody systems are the first range of titanium interbody implants benefiting from our proprietary Ti-LIFETechnology1.
Ti-LIFETechnology micro-porous scaffold mimics the bone trabecular structure and features interconnected pores of 600 μm to 700 μm and an overall porosity of 70-75% designed to enable cell colonization and promote bone in-growth2.
This technology is based on a unique algorithm associated with a state-of-the-art additive manufacturing process, often referred to as 3D printing.
The JULIET®Ti PO, OL and TL interbody systems include a full range of sizes to address different anatomies. The smooth bullet-shaped nose, lateral sides and chamfers of the implant are polished to preserve endplates, nerve roots and soft tissues during insertion.
The JULIET®Ti design features an overall reduced density to optimize imaging performance.
In accordance with the Spineart philosophy, the instrument set is ultra-compact and features multi-functional instruments.
All Spineart implants, including the entire JULIET®Ti range, are sterile packed and barcoded for increased safety, procedure compliance and cost-efficiency.
For distribution opportunities please contact us at contact@spineart.com or visit spineart.com/distributorsUSA.
1Filed patent
2Pre-clinical data may not represent clinical results.
In Vivo performance of selective electron beam-melted Ti-&Al-4V structures
Ponader, S et al., 2010
Evaluation of biological properties of electron beam melted Ti6al4V implant with biomimetic coating in vitro and in vivo.
Li, X et al., 2012
Porous titanium-6 aluminium-4 vandium cage has better osseointegration and less micromotion than a poly-ether-ether-ketone cage in sheep vertebral fusion.
Yang, J. et al., 2014
Does impaction of titanium-coated interbody fusion cages into the disc space cause wear debris or delamination?
Annette Kienle, MDa,*, Nicolas Graf, Dipl-Ing (FH)a, Hans-Joachim Wilke, PhDb
Direct three-dimensional morphometric analysis of human cancellous bone: microstructural data from spine, femur, iliac crest, and calcaneus
Tor Hildebrand, Andres Laib, Ralph Müller, Jan Dequeker, Peter Rüegsegger
Journal of bone and mineral research. Volume 14, Number 7, 1999
Porosity of 3D biomaterial scaffolds and osteogenesis
Vassilis Karageorgiou, David Kaplan
Biomaterials 26 (2005) 5474-5491
Chapter 8 – Bone Mechanics
Tony M. Keaveny, Elise F. Morgan, Oscar C. Yeh
Standard handbook of biomedical engineering and design
FIRST JULIET TI SURGERY PERFORMED IN GENEVA
Spineart is pleased to announce the world’s first implantation of the Titanium cages JULIET®Ti PO, featuring Ti-LIFETechnology, at the Clinique Générale Beaulieu in Geneva, Switzerland.
JULIET®Ti PO is a Titanium posterior cage featuring Ti-LIFETechnology a structure that mimics the bone trabecular geometry and is designed to promote bone in-growth.
Frédéric Schils, MD, neurosurgeon, successfully performed the procedure. After the surgery, Dr Schils commented: “it’s fascinating to actually benefit from the inter body cage we’d expected so long. The design made it easy to introduce while protecting the dura and the instruments are really intuitive. The Ti structure allows place for additional bone graft and is quite light suggesting interesting X-Rays possible after the surgery”
All Spineart implants are sterile packed and bar-coded for increased safety, procedure compliance and cost effectiveness.
For more information, please contact us at contact@spineart.com or visit spineart.com.
SPINEART LAUNCHES NEW TI-LIFE TECHNOLOGY 3D TITANIUM INTERBODY DEVICES
Spineart is pleased to announce that it has received CE marking for its new JULIET®Ti lumbar interbody systems.
The JULIET®Ti PO, OL and TL interbody systems are the first range of Titanium interbody implants benefiting from our proprietary Ti-LIFETechnology1.
Ti-LIFETechnology micro-porous scaffold mimics the bone trabecular structure and features interconnected pores of 600 μm to 700 μm and an overall porosity of 70-75% designed to enable cell colonization and promote bone in-growth2.
This technology is based on a unique algorithm associated with a state-of-the-art additive manufacturing process.
The JULIET®Ti PO, OL and TL interbody systems include a full range of sizes to address different anatomies. The smooth bullet-shaped nose, lateral sides and chamfers of the implant are polished to preserve endplates, nerve roots and soft tissues during insertion.
The JULIET®Ti design features an overall reduced density to optimize the imaging performances.
In accordance with the Spineart philosophy, the instrument set is ultra-compact and features multi-functional instruments.
All Spineart implants, including the entire JULIET®Ti range, are sterile packed and barcoded for increased safety, procedure compliance and cost-efficiency.
For additional product information and distribution opportunities, please contact us at contact@spineart.com.
1Filed patent
2 Pre-clinical data may not represent clinical results.
In Vivo performance of selective electron beam-melted Ti-&Al-4V structures
Ponader, S et al., 2010
Evaluation of biological properties of electron beam melted Ti6al4V implant with biomimetic coating in vitro and in vivo.
Li, X et al., 2012
Porous titanium-6 aluminium-4 vandium cage has better osseointegration and less micromotion than a poly-ether-ether-ketone cage in sheep vertebral fusion.
Yang, J. et al., 2014
Does impaction of titanium-coated interbody fusion cages into the disc space cause wear debris or delamination?
Annette Kienle, MDa,*, Nicolas Graf, Dipl-Ing (FH)a, Hans-Joachim Wilke, PhDb
Direct three-dimensional morphometric analysis of human cancellous bone: microstructural data from spine, femur, iliac crest, and calcaneus
Tor Hildebrand, Andres Laib, Ralph Müller, Jan Dequeker, Peter Rüegsegger
Journal of bone and mineral research. Volume 14, Number 7, 1999
Porosity of 3D biomaterial scaffolds and osteogenesis
Vassilis Karageorgiou, David Kaplan
Biomaterials 26 (2005) 5474-5491
Chapter 8 – Bone Mechanics
Tony M. Keaveny, Elise F. Morgan, Oscar C. Yeh
Standard handbook of biomedical engineering and design