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It turns out even highly-successful professionals can be plagued by everyday annoyances.

Aadil Diwan, Co-Founder and CTO of SafKan, is both an enterprising biomedical engineer, and an ordinary guy who’s been inundated with the overproduction of earwax since childhood. This malady, although seemingly trivial, meant frequent trips to the doctor to get the wax removed.

Sometimes, his wax production was so prolific that he would wake up in the morning and be completely unable to hear out of his left ear.

After Aadil graduated from the University of Arizona and began his career as a biomedical engineer, he was still dealing with the nagging problem of excessive earwax.Eventually, he learned that the technology behind how earwax is removed hasn’t changed in 200 years.

In 1821, an otologist began using a bladder syringe to remove earwax and that has remained the standard of care ever since.

So Aadil set out to come up with a better solution and began to envision a device that looks like a headset but that both irrigates the ear, which is what primary care physicians do, and also sucks with micro-suction, which ENTs do.

Aadil told his idea to his brother Sahil Diwan, who has almost a decade of experience launching and growing companies. Together, they began talking to doctors to feel out the potential interest in such a device and were elated by the positive feedback they received.

After talking to 110 physicians over three months, they learned that as long as they could keep the device within a reasonable price point, the physicians could absolutely see it becoming a new standard in care.

The Diwan brothers pulled together an engineering team in which three of the members have PhD’s in computer and electrical engineering. The team dove right in and began to develop the prototypes for what would soon be named OtoSet.

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3D printing has been invaluable in allowing the team to keep costs down as they can easily print the devices for testing in clinical trials. They’ve also been able to find the right advisors along the way, such as health accelerators which put them in front of the right investors.

It was while pitching their product at a conference that they were able to meet people from the cultivate(MD) team.

SafKan Clinical Trials and Next Steps

SafKan has begun manufacturing these devices and testing them in clinical trials. Their second clinical trial is currently underway where they are testing hard cases, such as unusually narrow ear canals or especially copious amounts of wax.

The next step will be to launch their beta program where physicians at UW Medicine Seattle, and Stanford Medicine’s Cedars-Sinai will be the first to test the OtoSet and provide feedback.

By the time they get FDA clearance, they are hoping to have a device that both physicians and patients will love.

Benefits of the SafKan OtoSet

One of the most important benefits OtoSet will offer to physicians is saving them from having to perform a 20 to 30-minute procedure that often puts them behind schedule and which nurses are not trained to perform.

One cycle on the OtoSet takes under a minute and the whole procedure, including cleaning the device, can be completed in 5 minutes.

Furthermore, the procedure can be easily implemented by a nurse with minimal training in the device.

Health systems are intrigued that OtoSet will reduce the number of unnecessary referrals from the primary care setting to the ENT setting and even keep patients from having to visit their primary care physician in the first place.

Instead, the procedure can be done at an urgent care or similar clinic.

With upwards of 10,000 earwax removals performed each year, that’s a lot of time saved for physicians and specialists.

Patient Experience With The SafKan OtoSet

OtoSet works through both pulse irrigation and continuous suction.

First, the device is placed on the patient’s head, much like a pair of headphones.

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The nurses are trained to make sure the tips are fitting properly into the ear canal and entering deep enough to be effective. However, the tips are not long enough to reach the eardrum or cause any damage.

Next, the nurse will select a button for either the left ear, right ear, or both ears at the same time.

When the nurse hits start, the device begins to perform a pre-wash that irrigates the ear canal with warm water and saline that sits for about 30 seconds, allowing the wax to soften and break down.

Next, the suction process begins to dislodge the wax and siphon it into a disposable outflow container.

Because the tips that enter the patient’s ears are also disposable, the nurse simply needs to perform a wipe down of the device and then store it.

OtoSet can run 100 procedures per charge, so it can always be used without needing to be connected to an outlet.

SafKan OtoSet Safety

The number one concern of physicians is wanting to know exactly what safety precautions are being taken to ensure there is no way this device could cause harm to a patient’s eardrums.

The first answer is that the pressure on the device is regulated by using pumps that are running at their maximum capacity, so there is never a possibility of them ever putting out any additional pressure.

Secondly, the device is designed so that the water always sprays towards the wall of the ear canal and never directly at the fragile eardrum.

With a bladder syringe, the water is being pushed straight at the eardrum creating the potential for damage. This indirect spraying design actually dislodges more wax because it hits several different spots inside the canal.

Many people are interested in the device’s accuracy, so they appreciate seeing SafKan’s many before and after pictures demonstrating OtoSet’s effectiveness.

The beta program will publish further case studies to show the outcomes.

cultivate(MD)’s Decision to Invest In SafKan

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As we learned about OtoSet’s technology and how SafKan is run, we saw a number of indications that SafKan is a company we would like to invest in through our cultivate(MD) fund.

We saw a company that was able to build a team of self-motivated engineers who moved quickly towards production in just a year and a half.

We were also impressed by how resourceful they had been with the investment money they had already received.

It soon became clear to us that this was a team of efficient workers with a great idea, serving an under-appreciated problem.

We expect SafKan to see great success with its product and are pleased to be able to partner with them in building their innovative technology.