2014

Statement regarding RENASYS™ NPWT in the United States

LONDON, June 23, 2014 /PRNewswire/ -- Smith & Nephew (LSE: SN; NYSE: SNN), the global medical technology business, announces that it has temporarily ceased commercial distribution of the RENASYS Negative Pressure Wound Therapy product line in the United States.

This action follows instruction from the FDA to obtain new regulatory clearances through the premarket notification (510K) process in respect of certain design enhancements made to RENASYS systems. The applications for clearance have now been filed and are awaiting action.

This action only affects RENASYS products in the United States. Other NPWT products, including PICO™, Smith & Nephew's portable, canister-free system, are not affected.

Smith & Nephew is working cooperatively with the FDA to address its concerns in order to resume distribution of RENASYS products in the United States as soon as possible and regrets any disruption caused to customers.

Sales of RENASYS products in the United States accounted for less than 5% of global Advanced Wound Management revenue in 2013.

About Smith & Nephew
Smith & Nephew is a global medical technology business dedicated to helping healthcare professionals improve people's lives. With leadership positions in Orthopaedic Reconstruction, Advanced Wound Management, Sports Medicine and Trauma & Extremities, Smith & Nephew has around 11,000 employees and a presence in more than 90 countries. Annual sales in 2013 were more than $4.3 billion. Smith & Nephew is a member of the FTSE100 (LSE: SN, NYSE: SNN).

For more information about Smith & Nephew, please visit our corporate website www.smith-nephew.com, follow @SmithNephewplc on Twitter or visit SmithNephewplc on Facebook.com

Forward-looking Statements
This document may contain forward-looking statements that may or may not prove accurate. For example, statements regarding expected revenue growth and trading margins, market trends and our product pipeline are forward-looking statements. Phrases such as "aim", "plan", "intend", "anticipate", "well-placed", "believe", "estimate", "expect", "target", "consider" and similar expressions are generally intended to identify forward-looking statements. Forward-looking statements involve known and unknown risks, uncertainties and other important factors that could cause actual results to differ materially from what is expressed or implied by the statements. For Smith & Nephew, these factors include: economic and financial conditions in the markets we serve, especially those affecting health care providers, payers and customers; price levels for established and innovative medical devices; developments in medical technology; regulatory approvals, reimbursement decisions or other government actions; product defects or recalls; litigation relating to patent or other claims; legal compliance risks and related investigative, remedial or enforcement actions; strategic actions, including acquisitions and dispositions, our success in performing due diligence, valuing and integrating acquired businesses; disruption that may result from transactions or other changes we make in our business plans or organisation to adapt to market developments; and numerous other matters that affect us or our markets, including those of a political, economic, business, competitive or reputational nature. 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 20-F, for a discussion of certain of these factors. Any forward-looking statement is based on information available to Smith & Nephew as of the date of the statement. All written or oral forward-looking statements attributable to Smith & Nephew are qualified by this caution. Smith & Nephew does not undertake any obligation to update or revise any forward-looking statement to reflect any change in circumstances or in Smith & Nephew's expectations.

™Trademark of Smith & Nephew. Certain marks registered US Patent and Trademark Office.

SOURCE Smith & Nephew



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