Regulatory Approval
Smith & Nephew Plc
10 May 2006
Smith & Nephew receives FDA approval for BIRMINGHAM HIP* Resurfacing system
10 May 2006
Smith & Nephew plc (LSE: SN, NYSE: SNN) announced today that the US Food and
Drug Administration (FDA) has approved the BIRMINGHAM HIP* Resurfacing
system for use in the United States. The BIRMINGHAM HIP Resurfacing system is
the only FDA-approved hip resurfacing product available for use in the US.
Hip resurfacing is an alternative to total hip replacement for patients
suffering from abnormalities of the hip, including osteoarthritis.
The BIRMINGHAM HIP Resurfacing system conserves more of a patient's bone than a
traditional hip replacement, enabling younger, more active patients to undergo
hip replacement surgery while preserving all future surgery options, including a
primary hip replacement. The design of The BIRMINGHAM HIP Resurfacing system
also offers patients a better range of natural motion with a reduced risk of
dislocation.
Sir Christopher O'Donnell, Chief Executive of Smith & Nephew plc, commented,
'BIRMINGHAM HIP Resurfacing is an important new addition to the options
available for patients in the United States. The procedure has already gained
significant market share in countries including the UK and Australia, and we
believe it has great potential in the US in patients who are considered too
young for conventional replacement surgery. We are pleased to be first to
market with a hip resurfacing product in the US, and the BIRMINGHAM HIP
Resurfacing system continues the momentum of our innovative new product launches
in orthopaedics.'
Enquiries
Investors/Media
David Yates/Debbie Scott Tel: +44 (0) 20 7831 3113
Financial Dynamics - London
Jonathan Birt Tel: +1 212 850 5634
Financial Dynamics - New York
Victor Rocha Tel: +1 901 399 6771
Smith & Nephew Orthopaedic Reconstruction
About us
Smith & Nephew is a global medical technology business, specialising in
Orthopaedic Reconstruction, Orthopaedic Trauma and Clinical Therapies, Endoscopy
and Advanced Wound Management products. Smith & Nephew is a global leader in
arthroscopy and advanced wound management and is one of the fastest growing
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 over 8,500
employees and operates in 33 countries around the world generating annual sales
of $2.6 billion.
Forward-Looking Statements
This press release contains certain 'forward-looking statements' within the
meaning of the US Private Securities Litigation Reform Act of 1995. In
particular, statements regarding expected revenue growth and trading margins
discussed under 'Outlook' are forward-looking statements as are discussions of
our product pipeline. These statements, as well as the phrases 'aim', 'plan',
'intend', 'anticipate', 'well-placed', 'believe', 'estimate', 'expect',
'target', 'consider' and similar expressions, are generally intended to identify
forward-looking statements. Such forward-looking statements involve known and
unknown risks, uncertainties and other important factors (including, but not
limited to, the outcome of litigation, claims and regulatory approvals) that
could cause the actual results, performance or achievements of Smith & Nephew,
or industry results, to differ materially from any future results, performance
or achievements expressed or implied by such forward-looking statements. 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 20F, for a
discussion of certain of these factors.
All forward-looking statements in this press release are based on information
available to Smith & Nephew as of the date hereof. All written or oral
forward-looking statements attributable to Smith & Nephew or any person acting
on behalf of Smith & Nephew are expressly qualified in their entirety by the
foregoing. Smith & Nephew does not undertake any obligation to update or revise
any forward-looking statement contained herein to reflect any change in Smith &
Nephew's expectation with regard thereto or any change in events, conditions or
circumstances on which any such statement is based.
* Trademark of Smith & Nephew. Certain names registered at the US Patent and
Trademark Office.
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