SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C.
20549
Report of Foreign Private Issuer
Pursuant to Rule 13a-16 or 15d-16
of the Securities Exchange Act of
1934
January 24, 2020
Commission
File Number 001-14978
SMITH & NEPHEW
plc
(Registrant's
name)
Building 5, Croxley Park,
Hatters Lane, Watford, Hertfordshire, WD18 8YE,
England
(Address
of registrant's principal executive offices)
[Indicate
by check mark whether the registrant files or will file
annual
reports
under cover Form 20-F or Form 40-F.]
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1934.]
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If
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in connection with Rule 12g3-2 (b) : 82- n/a.
Smith+Nephew acquires Tusker Medical, Inc., developer of
Tula, a new system for in-office delivery of ear tubes to treat
recurrent or persistent ear infections
The FDA-approved 'Breakthrough Device' is the first system that can
be used to place ear tubes in young children using local
anaesthesia in the physician-office setting
This acquisition is highly complementary to Smith+Nephew's ENT
portfolio, with the same customer and patient
populations
24 January 2020
Smith+Nephew (LSE:SN, NYSE:SNN), the global medical technology
business, today announces that it has acquired California-based
Tusker Medical, Inc. ("Tusker"), the developer of the Tula System,
an in-office solution for tympanostomy tubes (commonly known as ear
tubes). The acquisition supports Smith+Nephew's strategy to invest
in innovative technologies that address unmet clinical
needs.
Every year in the United States alone, approximately
700,0001 children
undergo tympanostomy tube placement surgery to address recurrent
ear infections or persistent fluid in the middle ear. These
procedures are traditionally performed under general anaesthesia in
operating rooms.
The Tula system enables placement of ear tubes in the physician's
office without general anaesthesia for patients six months and
older. Using Tula, a physician numbs the eardrum using novel,
child-friendly anaesthesia while the patient may sit up, play, and
watch videos. A specialised tube delivery system allows the
physician to place an ear tube precisely in less than half a second
using an automated device.
Tula received Breakthrough
Device2 designation
from the FDA, and on 25 November 2019 received pre-market approval
(PMA). At this time, Jeff Shuren, M.D., director of the FDA's
Center for Devices and Radiological Health,
said:
"Today's approval offers patients an option for the treatment of
recurrent ear infections that does not require general anaesthesia.
As millions of children suffer from ear infections every year, it
is important to have safe and effective treatments available to
this susceptible patient population. This approval has the
potential to expand patient access to a treatment that can be
administered in a physician's office with local anaesthesia and
minimal discomfort."
Tusker is highly complementary to Smith+Nephew's existing ENT
business, with the same customer and patient populations.
Smith+Nephew's COBLATION technology is widely used in tonsillectomy
and soft tissue management, and is used by both general and
paediatric ENT surgeons.
Brad Cannon, President of Sports Medicine & ENT at
Smith+Nephew, said:
"The Tula System is a truly innovative option for physicians
treating incredibly common ear conditions. It is a game-changer
when treating children, removing the risk and stress of general
anaesthesia for patients and caregivers. Tula is a highly
complementary addition to our ENT portfolio, and we are excited to
significantly improve the treatment options for surgeons and
patients with the launch of this technology."
Amir Abolfathi, President & Chief Executive Officer at Tusker,
said:
"I am immensely proud of the paediatric-focused technology
that we have developed, and to receive PMA approval along with
Breakthrough Device designation from the FDA. Smith+Nephew is
well-placed to accelerate and broaden the launch of Tula and we
look forward to working together to improve the quality of life of
the millions of children who suffer from ear infections every
year."
Tula consists of the Tula Iontophoresis System that induces local
anaesthesia using TYMBION™ and the Tula Tube Delivery System
that creates a myringotomy and inserts a tympanostomy
tube. Smith+Nephew expects to begin commercial launch of Tula
in the US in the first quarter of 2020. All
Tusker employees are expected to join
Smith+Nephew.
The transaction was financed from existing cash and debt
facilities. The commercial terms have not been
disclosed.
ENDS
Enquiries
Investors
|
|
Andrew
Swift
|
+44 (0)
1923 477433
|
Smith+Nephew
|
|
|
|
Media
|
|
Charles
Reynolds / Francesca Dunning
|
+44 (0)
1923 477314
|
Smith+Nephew
|
|
|
|
Charis
Gresser / Ayesha Bharmal
|
+44 (0)
20 7404 5959
|
Brunswick
|
|
References
1
Source: Hall et al. Ambulatory Surgery Data From Hospitals and
Ambulatory Surgery Centers: United States, 2010; National Health
Statistics Reports, 102, Feb 28 2017
2 According to the FDA, to qualify
for Breakthrough
Device designation, "a
device must be intended to treat or diagnose a life-threatening or
irreversibly debilitating disease or condition and meet one of the
following criteria: the device must represent a breakthrough
technology; there must be no approved or cleared alternatives; the
device must offer significant advantages over existing approved or
cleared alternatives; or the availability of the device is in the
best interest of patients." http://bit.ly/39OMSGX
About Smith+Nephew
Smith+Nephew is a portfolio medical technology business that exists
to restore people's bodies and their self-belief by using
technology to take the limits off living. We call this purpose
'Life Unlimited'. Our 16,000+ employees deliver this mission every
day, making a difference to patients' lives through the
excellence of our product portfolio, and the invention and
application of new technologies across our three global
franchises of Orthopaedics, Advanced Wound Management and Sports
Medicine & ENT. Founded in Hull, UK, in 1856, we now operate in
more than 100 countries, and generated annual sales of $4.9 billion
in 2018. Smith+Nephew is a constituent of the FTSE100 (LSE:SN,
NYSE:SNN). The terms 'Group' and 'Smith+Nephew' are used to refer
to Smith & Nephew plc and its consolidated subsidiaries,
unless the context requires otherwise.
For more information about Smith+Nephew, please
visit www.smith-nephew.com and
follow us on Twitter, LinkedIn, Instagram or Facebook.
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, payers 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 or other
problems with quality management systems or failure to comply with
related regulations; litigation relating to patent or other claims;
legal compliance risks and related investigative, remedial or
enforcement actions; disruption to our supply chain or operations
or those of our suppliers; competition for qualified personnel;
strategic actions, including acquisitions and dispositions, our
success in performing due diligence, valuing and integrating
acquired businesses; disruption that may result from transactions
or other changes we make in our business plans or organisation to
adapt to market developments; and numerous other matters that
affect us or our markets, including those of a political, economic,
business, competitive or reputational 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.
TYMBION is a trademark of Tusker
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf
by the undersigned thereunto duly authorized.
Smith
& Nephew Plc
(Registrant)
Date: January
24, 2020
By: /s/
Susan Swabey
-----------------
Susan
Swabey
Company
Secretary