FH Group Extends Total Disc Replacement Product Lines with DSM’s Bionate® PCU

New license promises to advance innovation in total disc replacement field

DSM Biomedical, a global leader in biomedical materials science, today announced the company has entered into a licensing agreement with orthopedic device manufacturer and distributor, FH Group.

The agreement grants FH Group the use of Bionate® PCU, a proprietary DSM Biomedical polymer, in its LP-ESP® (lumbar) and CP-ESP (cervical) disc replacement products. DSM Biomedical’s Bionate® PCU was chosen as the material for the disc replacement elastomer core based on its biocompatibility and elastomeric quality, enabling the implant to mimic motion of the human disc.

In 2006, the LP-ESP® received CE Mark approval and the first clinical implantations were performed. Currently, LP-ESP is used worldwide and offers one of the longest clinical histories of any elastomer disc replacement, with over three years of clinical follow-up.

“The development of the technology was a research-intensive, 10-year process that involved collaboration among a number of esteemed groups, individuals and companies including Commissariat à l’Energie Atomique – the most prestigious French government-funded technological research organization in cooperation with Professor Roy Camille of the renowned La Pitié hospital in Paris and Université Pierre et Marie Curie in Paris (UPMC),” said J.M. Idier, CEO, FH Group. “DSM Biomedical played a pivotal role in the process by providing biocompatible Bionate® PCU for this spinal implant,” he added.

“DSM Biomedical has been very successful in expanding our collaborative relationships with medical device manufacturers looking to extend their product offerings with novel or next generation devices,” said Rob Evans, Global Business Director, Biomaterials, DSM Biomedical. “We are excited about our work with FH Group, an organization which shares our company’s vision to deliver products that work to improve clinical outcomes for patients.”

About DSM Biomedical 
DSM Biomedical develops novel materials-based solutions to meet the present and future needs of the medical device and biopharmaceutical industries. The company’s product portfolio includes coatings, drug delivery platforms and a wide range of biomedical materials for use in short- and long-term implantable medical devices. Key product brands include Bionate® PCU and CarboSil® TSPCU, two of the most extensively tested biomedical polymers ever developed. Both polymers have excellent biostability, high strength and abrasion resistance, making them candidate materials for load-bearing orthopedic implants. ComfortCoat® hydrophilic and antimicrobial coating technology for catheters, guidewires and stent delivery systems; and Dyneema Purity®, a high-performance polyethylene fiber technology developed specifically for use in medical applications, such as orthopedic implants. The company also markets the Trancerta™ family of bioresorbable materials for drug delivery. This portfolio is based on DSM’s core strengths in materials science combined with its extensive in-house library of synthesis methods, formulation and processing techniques. For more information, visitwww.dsmbiomedical.com.

DSM – the Life Sciences and Materials Sciences Company 
Royal DSM N.V. creates solutions that nourish, protect and improve performance. Its end markets include human and animal nutrition and health, personal care, pharmaceuticals, automotive, coatings and paint, electrical and electronics, life protection and housing. DSM manages its business with a focus on the triple bottom line of economic performance, environmental quality and social responsibility, which it pursues simultaneously and in parallel. DSM has annual net sales of about €8 billion and employs some 22,700 people worldwide. The company is headquartered in the Netherlands, with locations on five continents. DSM is listed on Euronext Amsterdam. More information: www.dsm.com.

About FH Group 
FH ORTHOPEDICS designs and manufactures high-quality medical devices for orthopedic, trauma and spine applications.  Headquartered in France with global operations and distribution, FH Orthopedics has a 40-year history of collaborating with expert surgeons, leading hospitals and development partners to bring innovative orthopedic solutions to market across a broad range of applications.  The company’s portfolio includes two elastomeric total disc replacements designed to address lumbar and cervical pathologies. Key product brands for the spine are the LP-ESP® and CP-ESP®. In other fields, flagship products include the TLS® for ACL and PCL repair and the ARROW® and TELEGRAPH® for Shoulder arthroplasty and trauma. For more information: http://www.fhorthopedics.com/lombar-disc-lp-esp.html.