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Smith & Nephew plc (SNN)'s TRUCLEAR System: A Gold Standard for Removal of Intrauterine Polyps and Fibroids


4/6/2011 7:31:13 AM

ANDOVER, Mass., April 6, 2011 /PRNewswire/ -- Smith & Nephew's (NYSE: SNN; LSE: SN) Endoscopy Division today announced that its TRUCLEAR System, an operative hysteroscopy device for the removal of intrauterine polyps and fibroids, has surpassed the 30,000 procedure milestone.

The TRUCLEAR System is a first-of-its kind device that pairs the visualization capabilities of a hysteroscope with minimally invasive tissue removal capabilities, allowing a fast and thorough capture and removal of intrauterine polyps and fibroids; and provides healthcare practitioners in obstetrics, gynecology and reproductive health with a uniquely user-friendly technique.

It's widely believed that 3 out of 4 women in U.S. will have a fibroid at some point in their lifetime. According to a Medtech Insight November, 2007 report, abnormal uterine bleeding caused by uterine fibroids and polyps affect more than 4 million women in the U.S.

"The TRUCLEAR System was designed to overcome the primary challenges with current treatments," said Mira Sahney, GM, Gynecology for Smith & Nephew Endoscopy. "The system is optimized to thoroughly and efficiently remove tissue so that physicians are not required to make multiple, time-consuming insertions into the uterine cavity. This helps to reduce the risk of damage, which may also help preserve the chances of a future pregnancy."

According to recently published research**, hysteroscopic polypectomy and myomectomy in women with infertility, and without other gynecological symptoms, is effective in achieving a better pregnancy rate with fewer reported complications.

The TRUCLEAR System is designed to cleanly remove tissue from the uterine cavity, leaving the hysteroscopic view unobscured and ultimately allows healthcare practitioners greater clarity to complete a given procedure. Unlike other treatment options that use a high-frequency electric current, the TRUCLEAR System uses a simple mechanical approach to remove fibroids and polyps.

"The TRUCLEAR System has quickly become the standard of care that women deserve," commented Robert M. Biter, M.D., founder, Seaside Women's Health, San Diego, Calif. "It is a safe and effective way to diagnose and treat causes of abnormal uterine bleeding and risk of pregnancy loss. TRUCLEAR has truly revolutionized my practice."

UPDATE: Patent Infringement Litigation against Hologic, Inc.

Smith & Nephew has a patent infringement lawsuit pending in the U.S. District Court in Massachusetts against Hologic (Bedford, Mass.) (NasdaqGS: HOLX), claiming their MyoSure Tissue Removal System infringes a patent specifically used for the TRUCLEAR System and for minimally invasive treatment of intrauterine polyps and fibroids. The lawsuit was initially filed against Interlace Medical (Framingham, Mass.) which was subsequently acquired by Hologic in January, 2011.

Contact: Joe Metzger
SVP, Corporate Communications
Smith & Nephew Endoscopy
(978) 749-1330
joe.metzger@smith-nephew.com

Trademark of Smith & Nephew. Certain Marks Reg. U.S. Pat. & T.M. Off.

**Lieng M, Istre O, Qvigstad E. Treatment of endometrial polyps: a systematic review. Acta Obstet Gynecol Scand. 2010 Aug;89(8):992-1002; Bosteels J, Weyers S, Puttemans P, Panayotidis C, Van Herendael B, Gomel V, Mol BW, Mathieu C, D'Hooghe T. The effectiveness of hysteroscopy in improving pregnancy rates in subfertile women without other gynaecological symptoms: a systematic review. Hum Reprod Update. 2010 Jan-Feb;16(1):1-11

About Smith & Nephew

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

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.

SOURCE Smith & Nephew


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