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

Update on patent infringement case against Hologic, Inc.

ANDOVER, Mass., April 6, 2011 – 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

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