Sleep Systems is one of 20 medtech startups chosen as finalists in the 7th annual M2D2 $200K Challenge. Founder and CTO Chris Lyons told us about how their innovation came about and the company’s future vision.
What is the innovation you’ve entered in the M2D2 $200K Challenge?
Sleep Systems has developed a new methodology and a non-intrusive in-the-ear device to treat obstructive sleep apnea (OSA).
What inspired you to develop your device?
The inspiration for the apnea device was that I was diagnosed with moderate to severe sleep apnea and didn’t want to use the CPAP mask. I learned from my wife that moving my head into a horizontal position stopped my snoring and helped my breathing during sleep. I started researching sleep apnea and learned it’s caused by the mass of the tongue on the nasopharynx, the head region. Yet the industry had been monitoring the torso.
I applied some basic physics to the problem and concluded that the pitch and the roll angle of the head must be the real cause of obstructive sleep apnea and that a simple sensor mounted in the ear that generated an alarm when the head was in a position where the mass of the tongue could be pulled by gravity to block the airway could solve the problem. This was the inception of Sleep Systems Apnea Severity Equation, which is the basis of the new OSA treatment methodology and device. Our Equation was recently validated in a ten-subject clinical trial.
What are the most significant barriers you’ve faced and overcome?
The most significant barrier we have overcome is convincing the medical community that the pitch and roll angle of the head is the primary cause of OSA, not torso position, which has always been monitored in sleep studies. As we explained further to doctors the physics behind our apnea equation, they began to realize that we could be on to something significant. Since then, Sleep Systems has proven in clinical trials that it is the head and not the torso that controls sleep apnea severity.
Can you share a “Eureka” moment – a breakthrough in the development of your idea?
We have had multiple “Eureka” moments. The first was when I was having my second clinical sleep study for my CPAP prescription and asked the clinician if I could run an experiment by sleeping with my head at the horizontal for the duration of the study. In the morning, the clinician told me that I wouldn’t need a CPAP because I had no apnea during the night. That was Sleep Systems’ green light to file our patents.
The remaining “Eureka” moments were getting validation from doctors, clinicians, and specialists from both the Lahey and Mayo Clinics and from around the world at the AASM SLEEP 2017 conference. According to these doctors and scientists, they have just started researching the effects of head position on OSA in their own clinics. We knew from their feedback that we have something that will work for apnea sufferers.
If you win, what’s next?
If we win, Sleep Systems will have most of the funding needed to develop the next generation of prototypes required for the completion of regulatory strategy, final clinical trials, and final FDA approval.
You’re invited to meet ALL the finalists in person at the two upcoming events that will conclude the Challenge:
- Challenge Pitch-Off—Wednesday March 28 at 5:00 pm, University Crossing, 220 Pawtucket St., Lowell
- Finalist Awards & Networking Event—Tuesday April 10 at 5:00 pm, Mintz Levin, 1 Financial Center, Boston
For more information and tickets, visit https://www.eventbrite.com/e/m2d2-200k-challenge-finalist-pitch-off-awards-ceremony-tickets-43307428685