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 anesthesia in operating rooms.
The Tula system enables placement of ear tubes in the physician's office without general anesthesia for patients six months and older. Using Tula, a physician numbs the eardrum using novel, child-friendly anesthesia while the patient may sit up, play, and watch videos. A specialized tube delivery system allows the physician to place an ear tube precisely in less than half a second using an automated device.
Tula has received Breakthrough Device2 designation from the FDA, and in November 2019 received pre-market approval (PMA).
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 pediatric ENT surgeons.
Brad Cannon, president of Sports Medicine & ENT at Smith+Nephew, commented, "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."
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.
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