EarFlo Seeks to Revolutionize Treatment for Common Child Ailment 

by | Jan 31, 2023 | Companies

Most parents have spent a sleepless night with a child in pain from an ear infection, and many turn to surgically implanted ear tubes to alleviate the issue of chronic or recurring ear infections causing hearing loss that can lead to developmental delay. While the surgical procedure is relatively simple, it becomes complicated – and potentially more risky – because of the need for general anesthesia. But now an innovative new solution from a team participating in Fogarty’s Company Accelerator Program (CAP) will make solving the problem as easy as drinking from a cup, thanks to its new EarFlo device.

Ear infections a frequent childhood ailment

Otitis Media with Effusion (OME) is one of the most commonly occurring childhood illnesses in the United States with more than 2.2 million cases diagnosed each year at an estimated annual cost of $4 billion. As many as 90% of children will have at least one episode of OME by age five, and between 30 to 40% of children have recurrent episodes.

OME typically arises when the eustachian tubes are not functioning normally. As a child swallows, their eustachian tube, which connects the nasal cavity to the middle ear, equalize pressure. When the tubes are not working properly, fluid accumulates in the middle ear, causing hearing loss. OME is the most common cause of acquired hearing loss in childhood.

If the condition persists, ear tube surgery is typically recommended as an effective treatment. In this procedure, a ventilation tube is placed into the eardrum that drains the fluid and allows air to enter the middle ear to prevent a re-accumulation of fluid. 

Surgery no easy fix

When Dr. Matt Oldakowski, a biomedical engineer from Perth, Australia, and Dr. Jozef Bartunek, a cardiologist from Aalst, Belgium, were fellows in the Stanford Biodesign Global Faculty in Training (GFIT) program, part of their work involved shadowing ear nose and throat (ENT) specialists and looking for compelling problems to solve. One of the clinical mentors was Dr. Peter Santa Maria, a surgeon scientist and associate professor at Stanford, and as Matt followed him during his rounds, he noticed that one of the most common procedures was tube surgeries. 

“It was really routine – essentially only a five-minute procedure – but because the patient needed anesthesia, it required a longer check-in and recovery process, while increasing the risk of complications,” said Matt. It occurred to him that this could be avoided with a non-invasive way to treat the problem, and that was the genesis of EarFlo.  

The co-founding team behind EarFlo brings a wealth of expertise to the table. Matt is the CTO of EarFlo as well as being the co-director of Biodesign Australia and Perth Biodesign, along with CEO Intan Oldakowska, who is also co-director of Biodesign Australia and Perth Biodesign. Steve Kargotich is Stanford’s SPARK Global executive director, and Peter is an associate director at Stanford SPARK, in addition to his work as an ENT specialist. The entire team hails from Perth, Australia. 

Relief is just a drink away

Disguised as a sippy cup, the EarFlo medical device is designed to non-invasively treat OME in order to prevent developmental delay earlier and avoid surgery. As the child drinks from the cup, their nose presses into a silicone mask that delivers a gentle puff of air into the nasal cavity, coordinated with swallowing, to open the eustachian tube. The device is equipped with a pressure sensor to precisely control pressure and indicate when the treatment has been successfully administered.

“What we found in pilot clinical testing was that the amount of pressure needed to open the tubes is much lower than what previous devices have been using,” said Matt. “So we’re able to make our device much more comfortable for the child because it’s at a lower pressure.” 

While most current commercially available devices are developed for adults, they aren’t feasible or approved to be used in children under four who are most commonly afflicted by OME and at the greatest risk of developmental delay. “We’re confident we can translate our preliminary clinical data into a really great outcome,” said Intan. “We have a very compelling need and a big problem, and we’ve got a good device that can solve it for the young children that have no other non-invasive solutions.” 

Fogarty Innovation to put EarFlo on the path to success

As the newest member of Fogarty’s CAP, the team will participate in the six-month program that supports early-stage companies by helping them take their ideas to the next milestone. Successful CAP participants may later join Fogarty’s Company-in-Residence program, a next-level immersive support program that can last for two to three years.

In addition to assistance from Fogarty, EarFlo has been well-supported with several grants, including two Stanford-Coulter Translational Research grants, the UCSF-Stanford Pediatric Consortium, the Western Australia Telethon Trust Grant and the Child Health Research Grant from the Western Australian Department of Health, among others. 

EarFlo is currently in the preliminary clinical trial stage and is slated to launch in late 2024, pending results from clinical trials.

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