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Path4 and Investors Announce Creation of LDR Spine USA, Inc.
Austin, TX - January 27, 2005 LDR Medical is a European company led by former executives from JBS Spine. They have a proven track record for developing innovative yet simple solutions by involving the surgeons’ clinical perspective and ideas in the creation and development of their products, both in fusion and non-fusion devices. LDR Medical offers a complete spine portfolio and has developed innovative second-generation artificial discs for lumbar and cervical applications offering clear advantages to existing artificial discs that have been approved or are nearing approval in the U.S. market. LDR Medical’s lumbar artificial disc, Mobidisc™, has been implanted in more than 125 patients in Europe over the past year. The company’s new cervical artificial disc, Mobi-C™, recently started human implantations in Europe with impressive initial clinical results. Additionally, LDR Medical has an innovative fusion system, Easyspine™, which has been used successfully in over 2000 procedures in Europe. What makes Easyspine unique is its patent pending pedicle screw design with integrated polyaxial capability that can accommodate various thicknesses of rods. This approach provides many technical advantages and creates a system that uses one-third the inventory levels of conventional fusion systems. Other products that complete LDR Medical’s product portfolio include ROI™ and MC+™, partial vertebral body replacements for lumbar and cervical use, manufactured from state of the art PEEK-OPTIMA® material, along with BF+™, a proven synthetic bone substitute that works in conjunction with the company’s fusion products. These products will all be distributed by LDR Spine pending FDA 510(k) approval to market these devices in the U.S.A. "The Path4 team emerged as the strongest partners for us to enter the U.S. spine market," said Christophe Lavigne, president and CEO of LDR Medical "They, like us, have passion for this industry and believe in working closely with surgeons to deliver innovative solutions that improve patient care. We look forward to a long and prosperous partnership together." Steve Whitlock, a general partner with Path4, will become the president and CEO of LDR Spine USA, Inc. Mr. Whitlock commented, "The LDR team has created truly unique products that surgeons can appreciate. Their second-generation artificial discs are the only products that offer a six-degree of freedom solution to what is a six-degree of freedom problem -- no other discs have these advantages. They already have strong clinical results with human implantation and that gives us a clear advantage in the regulatory approval process." LDR Spine will be based in Austin, Texas and managed by the Path4 team. LDR Spine will be seeking approval for four products via the FDA’s 510(k) process and will seek to begin investigational device exemption (IDE) clinical studies for the two artificial discs next year. These products address the highly attractive spine segment in musculoskeletal medical devices with offerings in both fusion and non-fusion areas. About Path4 About LDR Medical LDR Medical has a unique range of innovative products for fusion and non fusion techniques, such as Mobidisc (artificial lumbar disc), Mobi-C (artificial cervical disc), ROI (Open radio transparent intersomatic implant), MC+ (Cervical modular cage), Easyspine (Spine posterior osteosynthesis), and the Alpha Screw (First polyaxial integrated connection). More information is available at www.ldrmedical.com. About Austin Ventures About the Rothschild Group About PTV Sciences
Company Contact: Copyright © 2004 PR Newswire. All rights reserved. © LDR Holding Corporation, All Rights Reserved |
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