Menlo Park, Calif.-based startup Tusker Medical Inc. has received U.S. FDA approval to market its breakthrough-designated system for inserting tympanostomy tubes into the eardrum to treat recurrent ear infections. The Tubes Under Local Anesthesia (Tula) system is the first delivery system for tympanostomy tubes, commonly known as ear tubes, that can be performed in young children under local anesthesia in a doctor’s office.

Tympanostomy tubes are inserted into the eardrum when antibiotics fail to adequately treat ear infections. Typically implanted by an ear, nose and throat (ENT) surgeon, the tubes help to drain fluid that accumulates in the middle ear during an infection and keep the area aerated and fluid free for a prolonged period of time. Most tube placements occur between the ages of 1 and 3, when the canal connecting the middle ear and the nose is smaller and more level than in adults, making it harder for fluid to drain out of the ear.

Huge market opportunity

In the U.S., tympanostomy tube procedures are the most common surgery performed under general anesthesia or children, and overall management of otitis media costs the healthcare system over $4 billion each year. An estimated 667,000 children younger than 15 years receive ear tubes annually in the U.S. By age 3, roughly 1 in 15 children has had tubes implanted. As the average OR-based procedure costs thousands of dollars, the Tula system, which requires neither an operating room nor general anesthesia, could be a real cost saver. It also avoids the risks of putting children under general anesthesia.

According to Zion Market Research, the worldwide market for tympanostomy tubes is expected to hit $102 million by 2025, growing at a compound annual growth rate of 1.8% between now and then. Key players in the space include Thermo Fisher Scientific Inc., Olympus Corp. and Grace Medical Inc.

The Tula system consists of the ionic anesthetic Tymbion, Tusker Medical tympanostomy tubes and several devices for inserting the anesthetic and tubes into the ear drum. A low-level electrical charge delivers the anesthesia to the eardrum prior to tube placement, allowing for quick and needle-free numbing of the tympanic membrane. With a single push of a button, the tube delivery system is designed to make a tiny incision in the eardrum and insert the tube in less than 500 milliseconds. Parents can remain with children during the procedure, and young children can sit on their parent’s lap if preferred.

The system is approved for use in adults and children as young as 3 years of age. It should not be used in children younger than 6 months who are allergic to some local anesthetics, as well as patients with preexisting eardrum problems, such as perforated eardrum.

‘Expand patient access’

“Today’s approval offers patients an option for the treatment of recurrent ear infections that does not require general anesthesia,” said Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health. “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 anesthesia and minimal discomfort.”

The FDA based its decision on Tusker Medical’s pivotal, multicenter, IDE-approved OTTER clinical trial, which evaluated the safety and effectiveness of the Tula system in 222 pediatric patients ages 6 months through 12 years in the U.S. and Canada. Results from the study show a procedural success rate of 86% in children younger than 5 and 89% in children ages 5 to 12. The most common adverse effect was inadequate anesthesia during the procedure.

Tusker Medical won a breakthrough device designation from the FDA for its Tula system, giving it increased access to agency staffers and guidance during the development and submission process.

The company was founded in 2016 by life sciences fund Apple Tree Partners with technology spun out of Johnson & Johnson Inc (J&J). J&J acquired the technology when it purchased Acclarent Inc., a company focused on ENT solutions, in 2009.

Tusker has raised about $34.5 million in three funding rounds, the latest being a $7 million financing that closed in April 2018. The company’s CEO is Amir Abolfathi, the founder of Sonitus Medical Inc., which closed its doors in 2015 after a negative coverage ruling from CMS on its Soundbite hearing system. The device was resurrected by Sonitus Technologies Inc., another Abolfathi company, as Molar Mic for military and rescue operations and snagged a U.S. Department of Defense contract in 2018.

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