Menu Spineart Search form Search Company Technologies Product platforms Education Clinical Distributors News 2017 2016 2015 2014 2013 2012 2011 2010 2009 2008 2007 2006 2005 24 November 2016 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. 20 September 2016 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 30 August 2016 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. 18 July 2016 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 14 July 2016 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. 13 July 2016 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. 1 Filed 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 5 July 2016 SPINEART ANNOUNCES PUBLICATION OF CLINICAL DATA FOR ITS BAGUERA®C ARTIFICAL CERVICAL DISC PROSTHESIS Spineart announced today the results published in the Journal of Spine from a multicenter European prospective registry for the BAGUERA ®C cervical disc prosthesis: Radiographic Outcome and Adjacent Segment Evaluation Two Years after Cervical Disc Replacement with the BAGUERA ®C Prosthesis as Treatment of Degenerative Cervical Disc Disease(1). A retrospective analysis of a large range of radiographic parameters was performed by an independent evaluator: 99 patients, treated for symptomatic degenerative disc diseases, by one- or two-level arthroplasty, using a total of 123 BAGUERA® C prostheses were included. Radiographic images at the treated and adjacent levels, as well at the overall cervical region, were analyzed. The results, 2 years after treatment by arthroplasty using BAGUERA® C, demonstrate good mobility at the treated and adjacent levels, disc height restoration and clear evidence of adjacent levels preservation. There were no signs of subsidence of the prostheses. Measures at the adjacent levels showed no signs of degeneration or kyphosis. Occurrence of heterotopic ossifications was considered low compared to data published by independent evaluators for other disc prosthesis. The publication further established cervical arthroplasty using the BAGUERA®C disc prosthesis as a safe, effective and motion preserving surgical treatment. The author also considered the results encouraging in terms of adjacent level disease protection. So far, more than 15'000 BAGUERA® C disc prosthesis have been implanted successfully worldwide. The first surgery was performed in France in January 2007. This implant is not available in the USA. For more information, please contact us at contact@spineart.com (1) «Radiographic Outcome and Adjacent Segment Evaluation Two Years after Cervical Disc Replacement with the Baguera®C Prosthesis as Treatment of Degenerative Cervical Disc Disease». Fransen et al., J Spine 2016, 5:2 (Journal of Spine ISSN: 2165-7939) http://www.omicsgroup.org/journals/spine-abstract.php?abstract_id=71753 13 June 2016 15 000 BAGUERA®C implanted Spineart is pleased to announce that, as of the 1st of June 2016, more than 15'000 BAGUERA® C have been successfully implanted worldwide. The first surgery was held in France in January 2007. The success of BAGUERA® C can be attributed to the implant’s key features which are its anatomical shape, shock-absorption, guided mobile nucleus and MRI compatibility. All Spineart implants are sterile packed and barcoded for increased safety, procedure compliance and cost-efficiency. This implant is not available in the USA. For more information, please contact us at contact@spineart.com 31 March 2016 International Course in San Diego The Education Department is pleased to announce that another International course was successfully completed on February 26th and 27th in San Diego, USA. The course was focused on degenerative cervical disc diseases and minimal invasive techniques with 16 attendees and 4 faculty members from 6 different countries. 18 February 2016 Announcement of FDA approval PERLA® Spineart announces that it has recently received 510(k) clearance from the U.S. FDA to market the PERLA® posterior cervico-thoracic fixation system. The system is intended for stabilization of spinal segments as an adjunct to fusion of the cervical spine (C1 to C7) and the thoracic spine (T1 to T3). PERLA® features a comprehensive implant range including preferred angle lateral mass and smooth shank screws, as well as nine different types of connectors for greater flexibility intraoperatively. Transitional rods (CoCr or Titanium) are available to extend the construct to the lumbar spine. In accordance with the Spineart philosophy, the instrument set is ultra-compact and features multi-functional instruments. All Spineart implants, including the entire PERLA® 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.us. 12 February 2016 First Baguera® surgery performed at the Cayman Islands The BAGUERA®- C cervical disc replacement has now been performed on two patients in the Cayman Islands by Drs. Lowell Stanley and Matthew Philips. Dr. Stanley is a graduate of the University of Kentucky Medical School and trained in neurosurgery at University of Texas Southwestern Medical School. Dr. Philips graduated from Yale University School of Medicine and completed his residency and spine fellowship at The University of Pennsylvania. The surgeries were performed at the Georgetown Hospital in conjunction with Cayman Brain and Spine and the Cayman Spine Centre, a state of the art facility dedicated to the treatment of spine conditions with particular focus on cervical surgical conditions. Since 2007, more than 13.500 BAGUERA® C have been implanted successfully worldwide. The success of the BAGUERA® C can be attributed to its main key features such as its anatomical shape, shock-absorption, guided mobile nucleus and MRI compatibility. All Spineart implants are sterile packed and barcoded for increased safety, procedure compliance and cost-efficiency. 6 February 2016 Spanish MIS Course hosted in Seville, February 4-5, 2016 Held in the reputed Nisa private Clinic, this course brought together 25 Neuro and Trauma surgeon from all over Andalucía: Seville, Cadiz, Huelva, Cordoba, Malaga and Granada. This course was hosted by three of the most experienced MIS surgeons in Spain who monitored the practical cadaver sessions and the theoretical lectures, which included several discussion on clinical cases. The audience was diverse and included both experts and novice surgeons who shared their experience with MIS techniques. 29 January 2016 Arab Health Spineart SA participated in the largest healthcare exhibition in the Middle East and Asia on January 24-28 in Dubai. The 2016 meeting showcased SCARLET®AC‐T and TEKTONA® (Vertebral Compression Fractures device), our last innovative products. We used this conference as an opportunity to meet with our distributors from the Middle East and new partners in the area. We are already making plans to participate in the 2017 meeting which will be hosted on January 30-February 2. Feel free to contact Mr Emmanuel SURCIN, Senior Sales Manager EMEA, for further information at esurcin@spineart.com. 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