Startups, Devices & Diagnostics

Pitch Perfect Winner Spotlight: These medical device entrepreneurs want to get the wax out of your ears (safely)

SafKan won the medical device track for the Pitch Perfect contest at the MedCity INVEST conference in Chicago earlier this month.

OtoSet device developed by SafKan Health

In a bid to help his brother develop a solution to a longterm ear problem, Sahil Diwan is the CEO and cofounder of SafKan Health, a startup that’s developed a medical device resembling a trendy set of earphones to make the job of removing excess and impacted ear wax in a safe manner easier. The idea is that the procedure, which is currently done by primary care physicians and Ear, Nose, and Throat doctors, could be carried out by nurses in primary care settings. That could free up primary care physicians and specialists to focus on more complex patients. 

SafKan was one of a group of winners of the Pitch Perfect contest at the MedCity INVEST conference in Chicago earlier this month, winning the medical device track. 

The OtoSet device, invented by SafKan CTOand cofounder Aadil Diwan, is designed to offer an alternative to ear syringing — a procedure that 12 million patients receive each year and is the leading standard of care. Diwan noted in a phone interview that the company’s research found that primary care physicians fail to remove the wax 30 percent of the time.

The headset has disposable silicone nozzles that spray saline solution against the outer walls of the ear canal while sucking the solution and wax back into the nozzles.

Describing the market opportunity, Sahil Diwan said in a phone interview that about 29 million people have excess or impacted earwax, citing data from the American Academy of Otolaryngology. 

A number of physicians, including primary care doctors and some ENT specialists, are taking part in a Beta program to assess the OtoSet device in the coming months. They come from institutions such as University of Washington Medicine, Stanford, Cedars-Sinai, and Providence Saint John’s Health Center. 

“We talked to a physician from a large health system in our Beta program to trial the device who wanted this procedure to be handled by nurses,” Diwan said. “In the clinic, they don’t want multiple visits for a simple procedure.”

Diwan acknowledged that there are lots of devices on the market, both over the counter and clinician facing. One of those is ClearEar, founded by biomedical engineer Lily Truong and a grad of Stanford MedX’s 2012 cohort, which developed a handheld device to soften and remove ear wax.

Earlier this year SafKan, which took part in a recent Dreamit Health cohort, closed an oversubscribed Seed round of more than $1 million. The lead investor in the round was Seattle Angel Conference, which invests in four companies each year. Another investor was the Philadelphia College of Osteopathic Medicine’s Primary Care Innovation Fund led by Dean Miller, the president of the  Philadelphia Alliance for Capital and Technologies. The $5 million fund seeks to stimulate innovation and entrepreneurship in the realm of primary care, according to its website. Dreamit also took part in the Seed round, Diwan said.

Future financing rounds will be used to finish manufacturing its OtoSet for the rest of the participants in the Beta round and to support sales and marketing of the devices. The business is currently preparing to submit an application to the FDA for approval of the device.

Longterm, Diwan said the company plans to roll out a DIY consumer version of the device, hoping to do for ears what Sonicare did for teeth.

“We want to take the credibility we build for the device with clinicians and use it for a consumer program, marketed as a Class One medical device.”

 

Photo: Jack Soltysik

Shares0
Shares0