EnsoData looks for FDA clearance after $550,000 fundraising round

Soon after a half-million dollar fundraising round, EnsoData is bringing on a “dream team” of consultants to help its sleep apnea diagnosis tool get federal clearance.

The round, announced yesterday and led by HealthX Ventures, will help the Madison startup as it looks to submit an application with the U.S. Food and Drug Administration, said co-founder and CEO Chris Fernandez.

“We’re going to double down on getting our submission together, write it out and prepare to send it as quickly as we can,” Fernandez said.

The company’s software eases the process for clinicians who analyze patients’ sleep data to see whether they have sleep apnea.

The vast majority of that data is analyzed manually right now, taking up countless hours of clinicians’ time and leading to patient wait times of several months. That’s one of the reasons why most people with sleep apnea go undiagnosed, leading to complications such as diabetes or strokes later on, Fernandez said.

“We are really trying to make this process faster and more efficient so more people can get the treatment they need and transform their quality of life,” he said.

Fernandez and his co-founder, Sam Rusk, both came up with the idea while getting their engineering degrees at UW-Madison.

But though they initially worked on the project with business students, they lacked business backgrounds themselves. That changed after they were part of the first cohort of gener8tor’s gBETA program, aimed at helping startups with ties to Wisconsin colleges.

“Going into it, we didn’t know a ton about business, startup economics, pitch decks, executive summaries, any of that stuff,” Fernandez said. “The gBETA program helped us get all of that together.”

And shortly after that program, EnsoData completed a fellowship with arguably the top accelerator in the world, Y Combinator, whose alums include Dropbox and Airbnb. During the fellowship, Fernandez said, the company met with “as many sleep clinics and possible,” giving them invaluable feedback on their product.

EnsoData is currently testing out its software with data from four clinics. Just like clinicians who do it by hand, it goes through patients’ sleep data and scores them in the same way that the American Academy of Sleep Medicine recommends, looking for the abnormalities that cause people to lose sleep.

“We’re not doing anything different, but we’re trying to do it 100 times faster and more consistently,” he said. “The clinics we’ve talked to thinks it makes a transformative difference.”

— By Polo Rocha,