Smith & Nephew Introduces Advanced Biocomposite Material for Use in Arthroscopic Surgery

     Smith & Nephew Introduces Advanced Biocomposite Material for Use in
                             Arthroscopic Surgery

PR Newswire

LONDON, Nov. 7, 2013

LONDON, Nov. 7, 2013 /PRNewswire/ -- Smith & Nephew (NYSE:SNN;LSE:SN), the
global medical technology business, announced the US launch of the HEALICOIL™
^ REGENESORB Suture Anchor at today's Arthroscopy Association of North America
(AANA) Fall Course in Las Vegas. Building on the success of the innovative
HEALICOIL PK design, this new suture anchor is the first device to use the
company's proprietary REGENESORB material – an advanced biocomposite that has
been shown in pre-clinical studies to be absorbed and replaced by bone within
24 months.[i] 

(Photo: http://photos.prnewswire.com/prnh/20131107/CL12216 )
(Logo: http://photos.prnewswire.com/prnh/20131030/CL06769LOGO )

"The HEALICOIL REGENESORB Suture Anchor is a perfect marriage of implant
design and material," says orthopaedic surgeon, Scott Trenhaile, Clinical
Assistant Professor of Surgery, University of Illinois College of Medicine at
Rockford. "Within this one implant, I get the bone ingrowth and mechanical
strengths of the original HEALICOIL, as well as the bioabsorption advantages
that come from gradually transferring the stresses to the healing bone as the
anchor is steadily absorbed."

Most biocomposite implants utilize the osteoconductive properties of beta
tricalcium phosphate (β-TCP) to provide 18 months of sustained bone
formation.[ii] While this is effective in creating a "scaffold" for enhancing
new bone formation,[iii] REGENESORB goes one step further by adding a second
osteoconductive component, calcium sulfate. Calcium sulfate has been shown to
work in the early stages of bone healing and is associated with increased
levels of local growth factors.[iv]

All HEALICOIL Suture Anchors use a unique, open-architecture design that
eliminates the inner diameter material found in traditional, solid-core
anchors. Pre-clinical testing has demonstrated that this design allows for new
bone to fill the spaces between the threads and within the central channel by
12-weeks after implantation.[v] In addition, the extended, fully-threaded
HEALICOIL REGENESORB anchor design was shown in biomechanical testing to
provide more threaded engagement than other biocomposite anchors; delivering
greater pullout strength in poor-quality, osteoporotic bone.[vi] Additionally,
the HEALICOIL inserter engages nearly 100% of the anchor's length, which
minimizes stress and provides predictable insertion into hard bone by
distributing torque along the entire length of the anchor.[vii]

"When we introduced the HEALICOIL PK Suture Anchor, its design set a new
standard for innovation in our industry," says Brad Cannon, President,
Endoscopy, Trauma and Extremities for Smith & Nephew. "With HEALICOIL
REGENESORB, we combined the benefits of that design with an advanced material
to raise the standard even higher."

Designed primarily for shoulder rotator cuff repair, the HEALICOIL REGENESORB
Suture Anchor is also indicated for use in the knee, elbow, foot and ankle.

Editor's notes:
Pre-clinical testing is based on laboratory research and not clinical testing
on actual patients. Therefore, it is not necessarily indicative of actual
clinical results. The biomechanical testing was conducted in 5pcf (pounds per
cubic feet) bone block, a substance with a density equivalent to the
worst-case, poorest-quality decorticated humeral bone.

The rotator cuff, which is made up of a group of four muscles whose tendons
converge to help stabilize and move the shoulder, is subject to a considerable
amount of wear and tear with regular daily activities – especially repetitive
overhead motions. Current Smith & Nephew estimates are that over 1 million
rotator cuff procedures are performed on an annual basis globally to alleviate
persistent pain and help patients regain a full range of motion.

About Smith & Nephew
Smith & Nephew is a global medical technology business dedicated to helping
improve people's lives. With leadership positions in Orthopaedic
Reconstruction, Advanced Wound Management, Sports Medicine and Trauma, Smith &
Nephew has around 11,000 employees and a presence in more than 90 countries.
Annual sales in 2012 were more than $4.1 billion. Smith & Nephew is a member
of the FTSE100 (LSE: SN, NYSE: SNN).

Forward-looking Statements
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Smith & Nephew, these factors include: economic and financial conditions in
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and customers; price levels for established and innovative medical devices;
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Nephew has filed with the U.S. Securities and Exchange Commission under the
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most recent annual report on Form 20-F, for a discussion of certain of these
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& Nephew does not undertake any obligation to update or revise any
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Nephew's expectations. 

^™ Trademark of Smith & Nephew. Certain marks registered US Patent and
Trademark Office. All Trademarks acknowledged.

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[i] In vivo animal testing has demonstrated that the composite material is
bioabsorbable and is replaced by bone. Implants (9x10 mm) were implanted in
ovine cancellous bone and compared to an empty defect (9x10 mm) at 6, 12, 18,
and 24 months (n=6). Micro-CT analysis demonstrated that by 24 months, bone
in-growth into this material (289.5 mm3) was significantly greater (p<0.05)
than bone in-growth into an empty defect (170.2mm3) and reaches a bone volume
not statistically different from intact bone (188.2 mm3). Results of in vivo
simulation have not been shown to quantitatively predict clinical performance.
Data on file at Smith & Nephew in report 15000897

[ii] Costantino PD, Friedman CD. Synthetic Bone Graft Substitutes.
Craniofacial Skeletal Augmentation and Replacement (1994) 27(5):1037-1074.

[iii] Ogose et al. Histological assessment in grafts of highly purified
beta-tricalcium phosphate in human bones. Biomaterials (2006), 27(8):
1542–1549.

[iv] Walsh et al. Response of a Calcium Sulfate Bone Graft Substitute in a
Confined Cancellous Defect. Clin. Orthop. and Rel. Res. (2003) 406:228-236.

[v] Validation 15001193 and in WRP TE024-94. Note: Animal data is not
necessarily indicative of human clinical outcomes. These results have not been
demonstrated in humans having a variety of bone quality based on specific
disease states such as osteoporosis. The effect of formation of new bone on
pullout strength was not shown.

[vi] Report Number 15002036 HEALICOIL Suture Anchor competitive testing. Data
on file. August 2013

[vii] Report Number 15002036 HEALICOIL Suture Anchor competitive testing. Data
on file. August 2013

SOURCE Smith & Nephew

Website: http://www.smith-nephew.com
Contact: Media, Joe Metzger, Smith & Nephew, +1 (978) 749-1330, or
Investor/Analyst, Phil Cowdy, Smith & Nephew, +44 (0)20 7401 7646
 
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