- Smith & Nephew said Friday it acquired Tusker Medical, which two months ago achieved FDA premarket approval for a treatment designed for children or adults with recurrent ear infections.
- The Menlo Park, California-based medtech developed the Tula System, an ear tube delivery system that can be used via local anesthesia alone in a doctor's office. Smith & Nephew plans to begin selling the product in the U.S. in the first quarter of 2020.
- Smith & Nephew did not disclose financial terms of the deal but said it was financed from existing cash and debt facilities. It expects all Tusker employees to join Smith & Nephew.
Tusker is one of the few breakthrough device-winning firms that can boast having already received U.S. marketing authorization, too. According to an FDA spokeperson, the agency doled out 136 breakthrough device designations in 2019, but just five breakthrough devices received a marketing go-ahead last year. The Tula system was one of three of those devices to make it to market via a more rigorous PMA submission. FDA's review took just under six months.
Tula is a system for inserting tympanostomy tubes, a treatment option when antibiotics fail to adequately resolve ear infections. The tubes ventilate the middle ear in an attempt to avoid fluid buildup behind the eardrum.
The 222-patient study supporting the FDA approval found the procedure successful in 86% of children younger than 5 and 89% in patients between the ages of 5 and 12. FDA authorized the device's use in patients as young as 6 months old.
At one point, Tusker's technology was under the purview of Johnson & Johnson, which acquired it from Acclarent in 2009 but later spun it out to life sciences fund Apple Tree Partners, which formed Tusker in 2016.
Smith & Nephew is slated to report full year 2019 financial results on Feb. 20. In its most recent quarter, Smith & Nephew's ENT business revenues grew slightly to $37 million, which the company attributed to adoption of its low thermal tissue removal product Coblation in tonsil and adenoid procedures.