Smith & Nephew Announces FDA Approval Of An Amended Label For SUPARTZ(R) Joint Fluid Therapy

MEMPHIS, Tenn., March 9 /PRNewswire-FirstCall/ -- Smith & Nephew Trauma division , today announced that the U.S. Food and Drug Administration (FDA) approved a label amendment for SUPARTZ(R) Joint Fluid Therapy. Although SUPARTZ Joint Fluid Therapy is still indicated for five weekly injections, the amendment to the directions for use and the precaution section of the labeling now allow physicians to choose as few as three weekly injections for their patients with osteoarthritis knee pain if the physician judges the patients would experience benefit.(1)

Joint Fluid Therapy is a treatment for osteoarthritic knee pain using intra-articular injections of hyaluronic acid. SUPARTZ Joint Fluid Therapy was the first hyaluronan joint fluid therapy commercially available for human use in treating osteoarthritis (OA). It has a long clinical history with more than 150 million injections of SUPARTZ Joint Fluid Therapy prescribed globally. It was approved in the US by the FDA in 2001.

"Joint fluid therapy can provide relief for debilitating knee pain without drugs or surgery," said Ken Reali, vice president and general manager for the Smith & Nephew Clinical Therapies division. "This approval provides both doctors and patients with greater options and control over their treatment of osteoarthritis knee pain."

Today, as many as 20 million Americans suffer from knee OA, and that number is expected to increase with the aging population and rising obesity rates. By the age of 65, approximately 80% of Americans have some sign of OA. Increases in life expectancy and aging populations are expected to make it the fourth leading cause of disability by 2020.

"This is a significant benefit for my patients because I can now treat each patient individually with SUPARTZ Joint Fluid Therapy, based on their osteoarthritis knee symptoms," said Dr. Orrin Troum of the Keck School of Medicine at the University of Southern California. "This precaution removal allows me to address each patient's needs individually, which is my goal in ensuring the optimal treatment outcome."

SUPARTZ Joint Fluid Therapy is covered by Medicare and most private payors.

About us

Smith & Nephew is a global medical technology business, specializing in Orthopaedic Reconstruction, Orthopaedic Trauma, Endoscopy and Advanced Wound Management products. Smith & Nephew is a global leader in arthroscopy and advanced wound management and is one of the fastest growing 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 has over 8,500 employees and operates in 33 countries around the world generating annual sales of $2.6 billion.

(1) This benefit was noted in a study where patients treated with 3 injections were followed for ninety days

Editors notes

SUPARTZ Joint Fluid Therapy, a three-to-five injection course of hyaluronic acid, is indicated for the treatment of pain from osteoarthritis of the knee in patients who have failed to respond adequately to conservative, non-pharmacologic therapy and simple analgesics, e.g., acetaminophen.

SUPARTZ is a Trademark of the Seikagaku Corporation. SUPARTZ is to be capitalized in all references. Forward-Looking Statements

This press release contains certain "forward-looking statements" within the meaning of the US Private Securities Litigation Reform Act of 1995. In particular, statements regarding expected revenue growth and 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, claims 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.

CONTACT: Victor Rocha of Smith & Nephew, +1-901-399-6771, orvictor.rocha@smith-nephew.com

Web site: http://www.smith-nephew.com/