Sathya Elumalai found it difficult to take care of his mother’s health after she was diagnosed with four chronic diseases. Instead of guessing her health status for the day, he decided to co-found Aidar Health to get that information directly and reliably.
While founding Aidar, Elumalai also created and launched MouthLab, a device that claims to track 10 key health parameters in less than a minute. The company is part of TechCrunch Disrupt 2022’s Battlefield 200.
“For a car, you have this check engine light that helps you say, it’s time to get your car [to a] dealer or mechanic to repair it. Similarly, our device acts as a way to monitor your health every day to provide a more holistic view of an individual’s health,” Elumalai said. “So if there are any abnormalities or any changes in that health from baseline, the device can alert and inform the user of those changes and what they can do to help manage their health. Or use the same data to communicate with their doctor or caregivers to better assess health status or changes or abnormalities in health at a very early stage.”
A user holds the iPhone-sized device and places their mouth over the mouthpiece, breathes normally, and places their hands on the device as instructed. The company claims the MouthLab will record temperature, respiratory rate, heart rate, blood pressure, breathing pattern, heart rate, heart rate variability, EKG, spirometry (i.e. lung function) and oxygen saturation. Data is collected from sensors in the device from saliva, breathing, hand and lip pulse to read body parameters.
In a world where digital and remote care has become the new norm thanks to the COVID-19 pandemic, doctors have often had to go off of what their patients say, which is a good starting point but not enough for long-term care. Although tests and labs were eventually done, there was no effective way to monitor the patient’s vital signs at home.
Aidar Health was able to obtain Class II FDA 510(k) clearance earlier this month. The authorization states that the device may pose some moderate risk to consumers, but allows the company to introduce the product for commercial distribution and market it. It is not clear what risks the permit covers. According to the company, the device has gone through three clinical trials and is embarking on a study in partnership with the VA Health System.
Today, there are over 800 active users of MouthLab and Aidar Health, who use them for remote vital signs monitoring, chronic care management and other home health services – as well as “real-world evidence generation efforts with life science companies” , Elumalai said (the latter probably means participating in surveys).
“The device is being used for remote physiological monitoring (RPM), chronic care management (CCM), hospital at home ([email protected]) services with health systems and digital biomarker development, digital satellite and real-world evidence generation efforts with life science companies,” Elumalai told TechCrunch.
The Maryland-based company says it is HIPAA compliant by using its own LTE/cellular network cloud. Once data is collected, it is sent to users through the mobile app and then sent to physicians through Fast Healthcare Interoperability Resources, an API for electronic health records.
The company has decided to operate on a subscription model that costs $50-80 per patient per month. Users are provided MouthLab, web and mobile app access, and doctors can collect vital signs and analytics. Depending on the use of the service, pricing may vary.
“It’s hard to really decipher what patients are really going through,” Elumalai said. “But a device like this, before we even contact a telemedicine doctor, we can instantly provide the data to them. So they get a complete snapshot of the patient’s medical history, a longitudinal analysis of the data for the last few days.