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Smith & Nephew Takes Single Injection PMA to Next Stage

RALEIGH and DURHAM, N.C., Aug. 19 /PRNewswire-FirstCall/ -- Smith & Nephew (NYSE: SNN; LSE: SN) Biologics & Spine is proceeding to the next stage in the approval process for the U.S. launch of DUROLANE(R) Single Injection, Stabilized Hyaluronic Acid.

Representatives from the product developer, Q-Med AB of Sweden ("Q-Med"), and their global commercial partner, Smith & Nephew met today with the FDA's Orthopaedic and Rehabilitation Devices Advisory Committee to discuss clinical evidence for the use of DUROLANE(R) in the treatment of knee pain caused by osteoarthritis ("OA").

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

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(R) Joint Fluid Therapy as a treatment for knee OA continues to increase and we are exploring its potential for other indications."

Q-Med CEO and founder Bengt Agerup said: "We are continuing the clinical development of DUROLANE(R) in collaboration with Smith & Nephew to provide satisfactory clinical evidence of DUROLANE(R)'s performance. We remain committed to our goal of providing U.S. physicians and patients access to a non-animal single injection product."

Ken Reali, SVP and General Manager of Biologics & Spine, added: "Our meeting with the Advisory Committee on single injection DUROLANE(R) 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(R). 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.

For media enquiries please call Katie Cralle, Brunswick Group 917 535 4543.

Editors Notes:

  1. DUROLANE(R) is produced using the unique NASHA(TM) (Stabilized Non-Animal Hyaluronic Acid) technology, a patented process for the production of stabilized hyaluronic acid. DUROLANE(R) 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. DUROLANE(R) 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(R) 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.

Forward-Looking Statements

This press release contains certain "forward-looking statements" within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. In particular, statements regarding planned growth in our business and in our operating margins discussed under "Outlook" are forward-looking statements as are discussions of our product pipeline. These statements, as well as the phrases "aim", "plan", "intend", "anticipate", "well-placed", "believe", "estimate", "expect", "target", "consider" and similar expressions, are generally intended to identify forward-looking statements. Such forward-looking statements involve known and unknown risks, uncertainties and other important factors (including, but not limited to, the outcome of litigation and regulatory approvals) that could cause the actual results, performance or achievements of Smith & Nephew, or industry results, to differ materially from any future results, performance or achievements expressed or implied by such forward-looking statements. Please refer to the documents that Smith & Nephew has filed with the U.S. Securities and Exchange Commission under the U.S. Securities Exchange Act of 1934, as amended, including Smith & Nephew's most recent annual report on Form 20F, for a discussion of certain of these factors. All forward-looking statements in this press release are based on information available to Smith & Nephew as of the date hereof. All written or oral forward-looking statements attributable to Smith & Nephew or any person acting on behalf of Smith & Nephew are expressly qualified in their entirety by the foregoing. Smith & Nephew does not undertake any obligation to update or revise any forward-looking statement contained herein to reflect any change in Smith & Nephew's expectation with regard thereto or any change in events, conditions or circumstances on which any such statement is based.

SOURCE Smith & Nephew
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