Severna Park, Maryland-based mobile sleep apnea-focused company Appian Medical has raised $580,000 from angel investors to conduct validation studies and apply for FDA 510(k) clearance for its app.
Appian CEO Michael Thomas told MobiHealthNews they are also starting talks with investors to raise their series A funding round. Thomas was formerly the CEO of asthma monitoring company iSonea.
Appian Medical's app, called SnoreSounds, uses an algorithm that the company licensed from University of Queensland in Australia. According to Thomas, the algorithm listens to the sounds of snoring to diagnose whether a patient has sleep apnea. Thomas said the app will eventually replace the current "gold standard" in sleep apnea diagnosis, which is polysomnography -- a sleep map study. He also adds that although Appian is developing an app with the technology, the algorithm could be used in several different form factors.
"It's an algorithm, so we can have the app sit in the cloud, and so the app is the gateway," Thomas said. "But essentially it's anything that has a microphone, and as long as the microphone can capture the snoring, we can take it from any device. It could be in the hospital, it could be in the home, it could be from a wearable sensor, it could be from anything really."
Appian Medical is also developing a second app, called SnorKids to help kids track when they have sleep apnea recurrences. This one will not diagnose the patient, but only track them after they've been diagnosed and treated.
The company plans to start a multi-tiered FDA submission process for SnoreSounds. The first clearance will be for an app that doctors can prescribe to patients. Then, they will submit another FDA 510(k) application for over-the-counter clearance so that patients won't need a prescription to download it. Although the price of the app, which patients will pay, has not been decided yet, Thomas said sleep lab tests cost $2,000 and in home tests cost $500, so the app will be a significantly cheaper option than either of those.
The clearances, and an additional funding round, will take place over the next eight to 12 months, he said. So far, the company has done two clinical trials at the University of Queensland. The first one has 41 patients and the second had 86.
Eventually Appian Medical plans to release more sleep apnea-related paid services for diagnosis and treatment until they are a "full service provider".
"So for example, let's say a patient takes diagnostic test and they're found to have sleep apnea, what if they get worried at that point?," Thomas said. "Well, maybe we offer them an immediate video phone consultation, like a FaceTime consult with a sleep specialist for $40 or $50. So it's basically on-demand to help patients walk through the results of their study. What does it mean? What should they do?"
Thomas adds that although there are other video consultation companies offering similar services, Appian's would be specifically targeted at patients who are dealing with sleep apnea. He also is planning to add a service to help patients who are going through continous positive airway pressure therapy (CPAP).
"So essentially it's a machine that takes room air, pressurizes it, and then blows it," Thomas said. "You look like Darth Vader when you go to bed, not the most pleasant thing, but it saves your life. A lot of people don't like to use it. So there are ways that we can have texting services to help patients be adherent to their sleep CPAP therapy."