Business
Smith+Nephew acquires Tusker Medical, Inc.
Smith+Nephew acquires Tusker Medical, Inc..
About this update from Smith & Nephew Plc
[{"type":"text","content":"\n \nRNS Number : 7923A Smith & Nephew Plc 24 January 2020 \n\n \nSmith+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\nThe 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\nThis acquisition is highly complementary to Smith+Nephew's ENT portfolio, with the same customer and patient populations\n24 January 2020\n \nSmith+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.\nEvery 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. \nThe 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. \nTula 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:\n\"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.\" \nTusker is...