First step towards treatment of spinal disorders with Artelon®


First step towards treatment of spinal disorders with Artelon®

Västra Frölunda, Sweden, April 8, 2009
Artimplant is taking its first step towards treatment of spinal disorders with
its proprietary biomaterial Artelon®. An Artelon® implant will now be used for
investigational treatment of osteoarthritis of the lumbar facet joints. The
investigator, Schulthess Clinic Spine Center, plans to start enrolling patients
during the second quarter of 2009. 

Schulthess Clinic Spine Center in Zürich has received the letter of confirmation
from Swissmedic to commence the clinical investigation of an Artelon® implant.
The aim of this pilot clinical investigation is to evaluate the feasibility of
treating painful osteoarthritis of the lumbar facet joints of the spine with an
Artelon® implant. The pain relief provided by this treatment will be examined
and the patients will be followed up for two years. The study will form the
basis for documenting the safety and ease of use of the Artelon® implant in
spine applications and establishing the post-surgical instructions.

Artimplant has more than nine years' clinical experience of Artelon® in the
treatment of osteoarthritis in small joints in the hand, wrist and foot. The
principles behind helping the body to heal and regain functional joints do not
differ to any great extent from one part of the body to another. Applying the
Artelon® resurfacing concept to the facet joint is a logical step for Artimplant
and is in line with the trend in spine surgery towards motion preservation.
Compared to other spine surgery alternatives the procedure is simple. Implanting
the Artelon® device is less invasive than most other spine procedures and can be
performed through the patient's back. Thereby the patient can resume normal
activities after a short recovery period.

Arthritis of the lumbar facet joints is a source of significant low back pain.
Like other joints in the body that are covered with articular cartilage, the
lumbar facet joints can be affected by arthritis. Normally, the facet joints fit
together snugly and glide smoothly, without pressure. If pressure builds up on
the joint surface, the cartilage is eroded. As a disc thins with aging and from
daily wear and tear, the space between the two spinal vertebrae shrinks. This
causes the facet joints to press together. Facet joints can also become
arthritic due to a back injury earlier in life. The body responds to this extra
pressure by developing bone spurs. Eventually, the joint surfaces become
arthritic. When the articular cartilage degenerates, or wears away, the bone
underneath is uncovered and rubs against bone. The joint becomes inflamed,
swollen and painful. 

The treatment for facet arthritis typically proceeds in a stepwise fashion.
Initially, anti-inflammatory medication is usually combined with some form of
physiotherapy. When primary treatment is no longer effective, surgery is an
option. Traditionally, fusion has been the standard approach. The basis of the
fusion concept is to immobilize the joint and hence the elimination of pain,
believed to originate from friction between the degenerated joint surfaces
during motion. While this approach can be effective in relation to the joint in
question, it is often accompanied by various drawbacks, such as loss of function
and overload of adjacent structures. Consequently, joint fusion is ultimately
abandoned in general orthopedics and replaced by artificial joint surgery. In
the spine, motion-preserving technology is still in a state of development and
expectations for the future are high. Some disc replacement and dynamic
stabilization products are available on the market. However, it is estimated
that more than 50 percent of patients with chronic back pain exhibit some or
most of that pain in the facet joints. A recently approved procedure known as
Total Disc Replacement (TDR) addresses degenerative disc disease (DDD) but fails
to treat degenerative facet joints, which usually contributes to back pain in
patients with DDD. Recent studies of patients who underwent TDR surgery indicate
that over 50 percent of patients have progression of facet joint disease two
years after the TDR procedure. Additionally, symptomatic facet joints are the
leading contraindication for TDR present in approximately 90 percent of patients
requesting TDR but later undergoing other spinal procedures. 

According to different U.S. National Institutes of Health back pain is the
second most common medical condition for which people seek medical treatment.
The spinal market is the third-largest and fastest-growing segment in the
orthopedic industry. Medtech Insight Inc. has estimated the total value of the
U.S. spinal market for 2008 at USD 2 billion. The majority of the value is
estimated to come from fusion implants that immobilize segments of the spinal
column. Future growth however, projected to add over USD 1 billion through to
2012, is anticipated to come from motion-preserving implants. The aim of the
Artelon® facet solution is to relieve pain and maintain the native function of
the facet joint. It is a game-changing technology that adds force to the
projected evolution. According to P&M Corporate Finance it is estimated that the
worldwide facet replacement market will grow from USD 5 million in 2009 to USD
500 million in 2015.

Artimplant's business operations are based on exploring the Company's unique
biomaterial platform Artelon®. There is considerable interest in Artimplant and
the technology the company controls. A positive result from this study,
performed by the Schulthess Clinic, will create a scientific and commercial
basis for the use of Artelon® in the facet application. Moreover, it will create
a foundation for other treatments of spinal disorders with Artelon® and increase
the interest in Artimplant.

Schulthess Clinic Spine Center, comments; 
“By using a new biologically based motion preserving technique, a physiological
treatment of degenerative facet joint disease (“facet syndrome”) of the lumbar
spine is introduced. We expect considerable advantages compared to the actual
fusion procedures.”

Hans Rosén, CEO Artimplant, says;
“We are very enthusiastic about the cooperation with Schulthess Clinic Spine
Center. The study is driven by an apparent clinical need to find a cure for
patients with chronic back pain related to osteoarthritis in lumbar facet
joints. At present there are no effective treatment options for this large
population of patients. The market potential for Artelon® in the treatment of
facet osteoarthritis is of significant value.”

For additional information, please contact:
Hans Rosén, CEO, phone +46 (0)31-746 56 00, +46 (0)708 58 34 70,
hans.rosen@artimplant.com

Katrin Gisselfält, VP Research & Development, phone +46 (0) 31 746 56 00, +46
(0)709 85 54 15, katrin.gisselfalt@artimplant.com 

Further information is available at www.artimplant.com. To subscribe to future
press releases please go to
www.artimplant.com/investors-media/subscribe-to-press-releases.html

Artimplant
Artimplant is a biomaterials company focused on solutions to problems in
orthopedic and oral surgery. We restore health through the development,
production and marketing of degradable implants that regenerate body functions
and improve quality of life. Our products, made from Artelon®, meet unmet
clinical needs and are marketed in a growing number of therapy areas. Artimplant
produces implants for treatment of osteoarthritis in hands and feet, for
shoulder and other soft tissue injuries as well as oral surgery and veterinary
medical applications. 

Artimplant is a public company listed on the NASDAQ OMX Stockholm Exchange in
the Small Cap segment and in the healthcare sector.

Schulthess Clinic
The Schulthess Clinic in Zurich, Switzerland, is one of Europe's leading
orthopedic hospitals. Its central mission is to free people from pain and
restore their mobility. As a top orthopedic hospital it specializes in the
sophisticated treatment of the musculoskeletal system for patients with joint,
back, hand and foot disorders. The Schulthess Clinic has a proven track record
with vast experience and high caseload of over 14,000 surgical interventions a
year. The Schulthess Clinic is also home to the Swiss Olympic Medical Center,
the FIFA Medical Assessment and Research Center and the FIFA Medical Center.
More information can be found in the Schulthess Clinic Corporate Video,
www.schulthess-klinik.ch/data/_flashfilms/11EN_KWS.html  

Forward-looking statements
This press release contains forward-looking statements as defined in the U.S.
Private Securities Litigation Reform Act of 1995. Readers are cautioned not to
place undue reliance on these forward-looking statements. Actual results may
differ materially from those indicated by these forward-looking statements as a
result of risks and uncertainties impacting the Company's business including
increased competition; the ability of the Company to expand its operations and
to attract and retain qualified professionals; technological obsolescence;
general economic conditions; and other risks detailed from time to time in the
Company's filings.

This is information which Artimplant is required to make public pursuant to the
Swedish Financial Instruments Act and the Swedish Securities Exchange and
Clearing Operations Act and/or stock market agreements. This information was
made available for publication on April 8, 2009 at 12:15 pm (GMT+1).

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