TIDMSN.
RNS Number : 7923A
Smith & Nephew Plc
24 January 2020
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 700,000(1)
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 Device(2) 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(TM) 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
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"aim", "plan", "intend", "anticipate", "well-placed", "believe",
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or those of our suppliers; competition for qualified personnel;
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(Trademark of Smith+Nephew. Certain marks registered US Patent
and Trademark Office. TYMBION) (is a trademark of Tusker)
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END
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