Q-Med and Smith & Nephew takes DurolaneTM PMA in USA to next stage

Q-Med and Smith & Nephew takes DurolaneTM PMA in USA to next stage

Q-Med has together with its global partner Smith & Nephew agreed to the next
stage in the approval process for the US launch of DurolaneTM Single Injection,
Stabilized Hyaluronic Acid.

Representatives from Q-Med AB, Sweden, and Smith & Nephew met August 19th with
the FDA's Orthopaedic and Rehabilitation Devices Advisory Committee to discuss
clinical evidence for the use of DurolaneTM in the treatment of knee pain caused
by osteoarthritis (“OA”).

The FDA Advisory Committee did not recommend DurolaneTM for immediate approval,
requesting further information as part of the Premarket Approval (“PMA”) process
for the product. Q-Med plans to work with Smith & Nephew and the FDA to provide
the data required.

Smith & Nephew and Q-Med have an exclusive relationship for the global
development and commercialization of Durolane. It is already marketed in 20
countries, including Canada, and has been used to treat the symptoms of OA in
more than 350,000 patients worldwide. 

Q-Med's CEO and founder Bengt Ågerup said, “We are continuing the clinical
development of Durolane in collaboration with Smith & Nephew to provide
satisfactory clinical evidence of Durolane's performance. We remain committed to
our goal of providing U.S. physicians and patients access to a non-animal single
injection product.”

Mark Augusti, President of Smith & Nephew Biologics & Spine, said: “We are
committed to expanding our range of HA therapies in the United States. Use of
our multi-injection SUPARTZ® Joint Fluid Therapy as a treatment for knee OA
continues to increase and we are exploring its potential for other indications.”

Ken Reali, SVP and General Manager of Biologics & Spine, added: “Our meeting
with the Advisory Committee on single injection Durolane provided some very
useful and valuable feedback on our Premarket Approval application. We intend to
work with our Q-Med partners and the FDA to initiate the next steps in making
this highly successful global product available to U.S. patients.”

Smith & Nephew and Q-Med have an exclusive partnership for the global
development and commercialization of Durolane. It is already marketed in 32
countries, including Canada, and has been used to treat the symptoms of OA in
more than 350,000 patients worldwide. 

Editors Notes:

1. DurolaneTM is produced using the unique NASHATM technology, a patented
process for the production of stabilized hyaluronic acid. DurolaneTM is a
transparent gel which contains high levels of HA (Hyaluronic Acid). HA is a
naturally occurring molecule that provides lubrication and cushioning in a
normal joint. Durolane is injected into knee joints affected by osteoarthritis
to relieve pain, restore lubrication and cushioning.
2. DurolaneTM is currently marketed in some 32 countries, including Canada,
Europe, Scandinavia, the Middle East, the Far East and South America. Outside
the United States, it is approved for the treatment of osteoarthritis of the hip
and knee.
3. SUPARTZ® is a registered trademark of Seikagaku Corp.


About Smith & Nephew - Smith & Nephew is a global medical technology business,
specializing in Orthopaedics, including Reconstruction, Trauma and Clinical
Therapies; Endoscopy and Advanced Wound Management. Smith & Nephew is a global
leader in arthroscopy and advanced wound management and is one of the leading
global orthopaedics companies. Smith & Nephew is dedicated to helping improve
people's lives. The Company prides itself on the strength of its relationships
with its surgeons and professional healthcare customers, with whom its name is
synonymous with high standards of performance, innovation and trust. The Company
operates in 32 countries around the world. Annual sales in 2008 were $3.8
billion.

Queries should be addressed to:
Bengt Ågerup, President and CEO
Tel: +46 70 974 9025

Per Langö, Senior Director Corporate Development
Tel: +46 73 387  1521


Q-Med AB is a medical device company. The company develops, manufactures,
markets, and sells primarily medical implants. The majority of the products are
based on the company's patented technology, NASHA™, for the production of
stabilized non-animal hyaluronic acid. The product portfolio today contains:
Restylane® for filling lines and folds, contouring and creating volume in the
face, Macrolane™ for body contouring, Durolane™ for the treatment of
osteoarthritis of the hip and knee joints, Deflux® for the treatment of
vesicoureteral reflux, VUR, (a malformation of the urinary bladder) in children,
and Solesta™ for the treatment of fecal incontinence. Sales are made through the
company's own subsidiaries or distributors in over 70 countries. Q Med today has
about 650 coworkers, with approximately 400 at the company's head office and
production facility in Uppsala, Sweden. Q-Med AB is listed in the Mid Cap
segment of the NASDAQ OMX Nordic. 


Q-Med AB (publ), Seminariegatan 21, SE-752 28 Uppsala, Sweden. Corporate
identity number 556258-6882.
Tel: +46 18 474 90 00. Fax: +46 18 474 90 01. E-mail: info@q-med.com. Web:
www.q-med.com.