DSM Extends License to Supply CarboSil® TSPCU For Use In AxioMed Spine Corporation’s Freedom® Spinal Discs

  DSM Extends License to Supply CarboSil® TSPCU For Use In AxioMed Spine
  Corporation’s Freedom® Spinal Discs

License for Use of Advanced Materials Technology in the Treatment of
Symptomatic Degenerative Disc Disease, a Common Cause of Low Back Pain is

Business Wire

BERKELEY, Calif. -- October 24, 2012

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

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

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

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
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