DSM Extends License to Supply CarboSil® TSPCU For Use In AxioMed Spine Corporation's Freedom® Spinal Discs
DSM, a global leader in biomedical materials sciences, and AxioMed Spine Corporation, an innovator in the field of spinal implant devices, today announced that they have revised and extended an existing licensing and supply agreement. DSM will supply its proprietary CarboSil® Thermoplastic Silicone-Polycarbonate-urethane material for use in AxioMed's Freedom® Lumbar and Freedom® Cervical Discs.
Symptomatic degenerative disc disease is one of the most common causes of low back pain and occurs when the intervertebral discs in the spine degenerate and lose flexibility, elasticity and shock absorbing characteristics. Treatment options include spinal fusion and total disc replacements (TDRs), the use of which have grown rapidly in part due to the increasing sophistication of the devices used in the procedures. In the United States, for example, more than 570 thousand spinal fusion procedures were performed in 2011, a 4.9% increase over 2010, according to the Millennium Research Group. Growth in TDR procedures has been even more dramatic, with nearly 20 thousand procedures performed in 2011, which represents an 11.9% increase over 2010 numbers. Spinal fusion joins two or more vertebrae together, immobilizing the faulty vertebrae and eliminating pain caused by abnormal motion. TDRs are designed to replace degenerated discs and allow motion in faulty vertebrae, which can lead to diminished disability and faster recovery times. TDRs also prevent the premature breakdown of discs in adjacent levels of the spine, a potential risk in fusion surgeries.
The first generations of TDRs were a ball and socket design using metal on metal materials. As the implants evolved, new materials were incorporated into their design including polymers. DSM's CarboSil® TSPCU is an advanced copolymer that combines the biocompatibility and biostability of conventional silicone elastomers with the processability and toughness of thermoplastic polycarbonate-urethanes. The material can improve in vitro and in vivo stability and helps prevent oxidative degradation, which can lead to improved patient results and longer lasting implants. The load bearing qualities of CarboSil® TSPCU help secure the total disc replacement device in place as it flexes with the natural movement of the spine. DSM's novel materials designed specifically for the spinal market are incorporated in three TDR devices, as well as eleven dynamic stabilization applications with additional applications in development
“Spinal fusion has been the standard of care for degenerative disc treatment, but recently payer groups and insurance companies have begun lowering reimbursements for fusion procedures and questioning its cost and applications to certain patient groups,” said William Fuller, Director of Business Development, Orthopedics at DSM Biomedical. “This creates an opportunity to highlight the benefits of total disc replacements and DSM material technology as AxioMed's Freedom® Lumbar Disc undergoes clinical trials in the United States.”
AxioMed first introduced the Freedom® Lumbar Disc and the Freedom® Cervical Disc in Europe and received CE Mark approvals in May 2009 and May 2012, respectively, which proved instrumental in the Freedom® Lumbar Disc device becoming the first elastomeric disc to receive an Investigational Device Exemption (IDE) from the U.S. FDA. The disc is currently under evaluation in an ongoing multi-center U.S. and EU IDE pivotal clinical study designed with efficacy, safety and economic endpoints.
“The viscoelastic material properties of CarboSil® TSPCU and proven track record of DSM's technology are ideal for our spinal discs,” said Patrick McBrayer, AxioMed's President and CEO. “Our aim is to provide patients with pain relief, reduced disability and improved lifestyle by combining our companies' innovations.”
DSM – Bright Science. Brighter Living.™
Royal DSM is a global science-based company active in health, nutrition and materials. By connecting its unique competences in Life Sciences and Materials Sciences, DSM is driving economic prosperity, environmental progress and social advances to create sustainable value for all stakeholders. DSM delivers innovative solutions that nourish, protect and improve performance in global markets such as food and dietary supplements, personal care, feed, pharmaceuticals, medical devices, automotive, paints, electrical and electronics, life protection, alternative energy and bio-based materials. DSM's 22,000 employees deliver annual net sales of around €9 billion. The company is listed on NYSE Euronext. More information can be found at www.dsm.com.
About AxioMed Spine Corporation
AxioMed's mission is to develop products focused on spinal function for patients with degenerative spine disease, thus advancing the standard of care beyond fusion and first generation discs. The Freedom® Lumbar and Cervical Discs have been developed and designed by a team of clinicians and experts in the fields of biomechanics, pathology, spinal surgery and polymer science. Focusing on restoration of the natural function of the spine, AxioMed will enhance human health through research, innovation, development and service world-wide. For more information about AxioMed, please visit our web site at www.axiomed.com.
CarboSil is a registered trademark of Royal DSM N.V.
Freedom is a registered trademark of AxioMed Spine Corporation.
Kwittken & Company for DSM
Abhi Basu, (646)-747-7174