FDA Clears PICO* Single Use Negative Pressure Wound Therapy System From Smith & Nephew, Expanding Patient Access

ST. PETERSBURG, Fla., Jan. 6, 2012 /PRNewswire/ -- Smith & Nephew plc (LSE: SN, NYSE: SNN), the global medical technology business, announces the FDA clearance of the pocket-sized PICO* system, a single use Negative Pressure Wound Therapy (NPWT) system.  PICO is cleared for use both in a hospital and homecare setting and expands the use of NPWT from the traditional wound care population to include a wider range of patients undergoing orthopaedic surgery, plastic surgery and general surgical procedures.  This FDA clearance follows the recent successful launch of PICO in Europe, Canada, and Australia.

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"PICO is novel and beneficial in several regards," said Dr. Raymond Dunn, Chairman of Plastic Surgery, University of Massachusetts. "The seven day duration should allow us to more rapidly transition care for patients with post-operative wounds and skin grafts to the outpatient setting.  With the simple pump, on-off design and absence of any canister or reservoir for fluid, patients can manage their NPWT at home much more easily, without additional nursing visits. This saves the healthcare system money and improves patients' quality of life." 

Smith & Nephew has been a leader in the wound care market for more than a century. The company has employed years of customer feedback and market research in the PICO system's design to ensure a patient friendly experience that addresses the needs and preferences of clinicians and payers as well. 

Clinicians can be confident that the PICO system is providing NPWT safely and effectively in a wide range of wounds and care settings. The PICO system is indicated for chronic, acute and traumatic wounds, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts, and closed surgical incisions.  The PICO system is as easy to apply as a conventional wound dressing, reducing the need for the staff time, intensive training and administrative paperwork associated with traditional NPWT.  The simple application technique can be viewed online via an MS Tag included on the packaging.

For the patient, the PICO system's one-button pump is easy-to-use and its small size and silent operation provide a discreet, unobtrusive way to carry on daily life with NPWT. The disposable device works with a revolutionary dressing technology that manages fluids, eliminating the need for bulky canisters. The system can be worn on a wound up to a week, depending on the level of exudates.  Its gentle silicone wound contact layer helps minimize pain at a dressing change.

For the Payer, the PICO system is more affordable than traditional NPWT, and can significantly reduce therapy costs associated with traditional NPWT. The PICO system is available off-the-shelf and therefore may reduce the occurrence of delayed hospital discharges.

"We are the first company to deliver effective, single use, disposable NPWT using the combination of a small, portable pump and advanced dressing technology," said Thomas Dugan, President, Smith & Nephew Advanced Wound Management, North America. "The PICO system demonstrates our commitment to innovation and reinforces our pledge to help reduce the human and economic cost of wounds."

Clinicians and patients can also refer to the 24/7 negative pressure wound therapy hotline, 866-998-NPWT (6798), for more information about the NPWT portfolio of products from Smith & Nephew.

For more information about the PICO system, please visit our mobile compatible website at www.possiblewithpico.com or follow the @woundcare Twitter handle for the latest news from the Advanced Wound Management division of Smith & Nephew. Register at www.twitter.com today.

About Smith & Nephew

Smith & Nephew is a global medical technology business with global leadership positions in Orthopaedic Reconstruction, Advanced Wound Management, Sports Medicine, Trauma and Clinical Therapies. The Company has distribution channels, purchasing agents and buying entities in over 90 countries worldwide. Annual sales in 2010 were nearly $4.0 billion.

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.

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, payors 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 and our success in integrating acquired businesses; and numerous other matters that affect us or our markets, including those of a political, economic, business or competitive 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 Wound Management

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