Tusker Medical's Tula System Receives FDA Approval for Office-Based Ear Tube Placement Under Local Anesthesia

VCBeat (WeChat ID: vcbeat) learned from foreign media that on November 25, 2019, local time, Tusker Medical, an otolaryngology medical solutions provider headquartered in Menlo Park, California, announced that its Tula in-office delivery system had received FDA marketing approval for the treatment of recurrent ear infections.

It is understood that ear infections are common among children in the United States, with five out of six children experiencing at least one episode before the age of three. Although doctors typically prioritize prescribing antibiotics, surgical intervention under general anesthesia—specifically the insertion of tympanostomy tubes (ear tubes) into the eardrum—is recommended when treatment fails or infections recur. Statistical data indicate that approximately 670,000 American children under the age of 15 undergo this high-cost ear tube surgery annually.

Tusker Medical’s Tula system is the first middle ear tube delivery system designed for use under local anesthesia. The system comprises the anesthetic Tmbion, a middle ear catheter, and several devices required to deliver the ear tubes and anesthetic to the tympanic membrane. It utilizes a low-level electrical current to deliver the local anesthetic to the tympanic membrane, enabling rapid and painless myringotomy and ear tube insertion after approximately 10 minutes. This novel treatment approach not only eliminates the risks associated with general anesthesia but also obviates the need for operating room scheduling, as the procedure can be performed in a physician’s office, thereby reducing healthcare costs.

“This approval provides patients with a new option for treating recurrent ear infections without the need for general anesthesia,” said Dr. Jeff Shuren, Director of the FDA’s Center for Devices and Radiological Health. “Given that millions of children suffer from ear infections each year, it is crucial to have safe and effective treatment options available for this susceptible patient population.”

It is reported that the FDA’s decision was based on the results of the multicenter, pivotal OTTER clinical trial conducted by Tusker Medical in the United States and Canada. The trial enrolled 222 children aged 6 months to 12 years and aimed to evaluate the safety and efficacy of the Tula System. Study results showed a surgical success rate of 86% in children under 5 years of age and 89% in children aged 5–12 years. The most common adverse event was inadequate anesthesia during the procedure.

The FDA noted that the Tula System has been approved for use in adults and children aged 6 months and older, but is not suitable for patients under 6 months of age with allergies to local anesthetics, nor for patients with tympanic membrane abnormalities.

Tusker Medical was founded in 2016 by the life sciences fund Apple Tree Partners. The company is dedicated to providing innovative technologies to otolaryngologists and their patients, with its core medical technology spun out from Johnson & Johnson. According to Crunchbase, Tusker Medical has completed three rounds of financing, raising a total of approximately $34.5 million, with its most recent being a $7 million venture capital round closed in April 2018.

(Compiled by Hu Lushuang)