DSM Biomedical, a global company serving the medtech and biotech industries
and part of Royal DSM N.V., announces two customers, AxioMed Spine and
Sunshine Heart, are celebrating commercial and clinical success of their
medical devices made with proprietary DSM Biomedical polymers.
AxioMed® Spine Corp. has recently received CE Mark approval for its Freedom®
Lumbar Disc, an elastomeric total spinal disc replacement device. The CE Mark
clears AxioMed to introduce the medical device into the European Union market.
Using a patented silicone-urethane copolymer under exclusive license from DSM
Biomedical, AxioMed's lumbar disc is designed to replicate the natural
function of a human disc. The Freedom® Lumbar Disc was developed and designed
by AxioMed clinicians and experts in the fields of biomechanics, pathology,
and spine surgery in combination with DSM Biomedical experts in polymer
science and processing. The material characteristics of DSM Biomedical's
polymer, in combination with AxioMed's implant design, provides
three-dimensional motion that mimics the natural biomechanics of the spine.
"We believe our Freedom® disc may represent the next generation of technology
for treating degenerative disc disease," said Patrick McBrayer, AxioMed's
President and CEO. "The goal of our technology is to restore the natural
function of the spine. DSM Biomedical's polymer is well-suited to this goal.
Its viscoelastic properties allow for compression, rotation and translation,
while simultaneously providing load transfer and damping."
Sunshine Heart Inc. recently announced that The Ohio State University Medical
Center has successfully completed the first two implants of the Company's
C-Pulse™ heart assist system under a 20-person clinical trial approved by the
FDA. C-Pulse is designed as a non-blood contacting heart assist therapy for
treating patients with moderate to severe heart failure, a condition in which
the heart progressively loses its ability to efficiently pump blood throughout
the body. The C-Pulse device, which must pulsate up to 750,000 times per week,
is made with two DSM Biomedical polymers.
"We started working with DSM Biomedical on an exploratory development program,
advanced to a manufacturing program, and in result have developed a very
durable Cuff for the C-Pulse," said Donald Rohrbaugh, CEO of Sunshine Heart.
"We are very pleased with the partnership that has developed between Sunshine
Heart and DSM Biomedical."
"We are very happy to partner with these two emerging medtech companies,"
added Bob Ward, President and CEO of DSM PTG, a part of DSM Biomedical. "The
major milestones achieved by AxioMed Spine and Sunshine Heart occur within one
year of the acquisition of The Polymer Technology Group (PTG) by DSM. Today,
the combined resources of the former PTG and DSM ensure continued investment
in new technology for delivering biomedical materials that advance or enable
the development of next-generation medical devices."
About DSM Biomedical
DSM Biomedical develops novel
materials-based solutions to meet the present and future needs of the medical
device and pharmaceutical industries. Building on the expertise and strengths
of DSM and its acquisition of DSM PTG (formerly The Polymer Technology Group),
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® TPU and
CarboSil® TSPU, 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™ Drug Delivery approach, which is based on
DSM's core strengths in polymers combined with its extensive in-house library
of synthesis methods, formulation and processing techniques. For more
information, visit www.dsmbiomedical.com
.
DSM - the Life Sciences and Materials Sciences Company
Royal
DSM N.V. creates innovative products and services in Life Sciences and
Materials Sciences that contribute to the quality of life. DSM's products and
services are used globally in a wide range of markets and applications,
supporting a healthier, more sustainable and more enjoyable way of life. End
markets include human and animal nutrition and health, personal care,
pharmaceuticals, automotive, coatings and paint, electrical and electronics,
life protection and housing. DSM has annual net sales of EUR 9.3 billion and
employs some 23,500 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 Sunshine Heart
Sunshine Heart (ASX: SHC) (
www.sunshineheart.com) is a global medical device company, committed to
the commercialization of C-Pulse™ an implantable, non-blood contacting, heart
assist therapy for the treatment of people with moderate heart failure.
C-Pulse reduces the symptoms of heart failure through the use of
counterpulsation technology which enables an increase in cardiac output, an
increase in coronary blood flow and reduction in the heart's pumping workload.
The Company has received approval from the U.S. Food and Drug Administration
(FDA) to conduct a 20 person U.S. feasibility clinical trial with C-Pulse and
patient enrolment and implants have commenced. Sunshine Heart listed on the
ASX in September 2004 has a presence in Australia, New Zealand and the United
States of America.