Smith+Nephew (LSE: SN, NYSE: SNN), the global medical technology business, is pleased to announce the market introduction and first commercial procedure of its Tula System an in-office solution for placement of tympanostomy tubes (commonly known as ear tubes).

The Tula System gives ENT surgeons an option to place ear tubes in an awake child during an office visit without the need for general anaesthesia. The physician numbs the eardrum using a novel, child-friendly anaesthesia while the patient may sit up, play, and remain with their parent. A specialized tube delivery system allows the physician to place an ear tube in less than half a second, minimizing the amount of time the child needs to remain still. Most children return to normal activities immediately following the Tula procedure.1,2

The first procedure utilizing the Tula System since receiving FDA approval was successfully performed yesterday by Dr. Ritvik Mehta, MD, Otolaryngologist of California Head and Neck Specialists and investigator in the Tula Pivotal Clinical Study. 'This personally hits home as my daughter had ear tube placement performed in the operating room,' explained Dr. Mehta. 'Even though I'm in a position to know exactly what to expect, it was a stressful event. I'm genuinely excited to be able to perform the same ear tube procedure, but in an office setting where children and families may avoid exposure to the risks and stresses of general anaesthesia - fasting, separation and after effects. This is a significant improvement to what we as ENTs can offer our patients.'

Acute otitis media (commonly referred to as an ear infection) is one of the most prevalent childhood ailments in the United States, with an estimated annual cost of $2.8 billion.3 Every year in the United States alone, approximately 700,000 tympanostomy tube procedures are performed on children to address symptoms related to recurring ear infections and fluid in the middle ear.4

'I really like the Tula System because it gives parents the option of getting their child's ear tubes placed without a general anaesthetic,' said Dr. Lawrence Lustig, Department Chair of Otolaryngology-Head & Neck Surgery Columbia University School of Medicine and New York Presbyterian Hospital and Principal Investigator of the Tula Pivotal Clinical Study. 'From a parent's perspective, this is an enormous advantage - less time off work, and performed in an office setting. This technology represents a broader movement in our field towards patient-centered therapies.'

'We are very excited to deliver a truly disruptive technology that elevates the standard of care by providing an alternative to general anaesthesia-based tympanostomy,' said Brad Cannon, President, ENT and Sports Medicine for Smith+Nephew. 'And, by better utilizing limited healthcare resources and freeing up precious OR space, it may potentially save the overall healthcare system hundreds of millions of dollars.'

The Tula System is now available in select markets in the United States and will be available nationwide by the beginning of 2021.

Contact:

David Snyder

Tel: +1 978-749-1440

Risk Statement

The Tula System is intended to create a myringotomy and insert a tympanostomy tube using the Tula Tube Delivery System in pediatric (aged 6 months and older) and adult patients indicated to receive tympanostomy tubes. The Tula System is used to deliver a tympanostomy tube under local anesthesia induced using the Tula Iontophoresis System and TYMBION, a combination of an amide local anesthetic and an alpha- and beta-adrenergic agonist. Contraindications include certain abnormal ear anatomy, sensitivity/allergy to lidocaine or other local anesthetics, and reliance on electrically sensitive medical implants such as a pacemaker. Risks may include, but are not limited to, inadequate local anesthesia, dizziness, and common tympanostomy procedure risks.

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 17,500+ 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 $5.1 billion in 2019. 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.

Forward-looking Statements

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