SleepX applies to the Helsinki Committee for approval on its clinical trial with the SleepX PRO smartphone application SleepX PRO is designed to diagnose sleep apnea using only a smartphone, and with no physical contact
Boca Raton, Florida
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March 23, 2022 07:53 AM Eastern Daylight Time
SleepX, a subsidiary of AppYea (OTC: APYPD) focusing on the development of accurate wearable monitoring solutions to treat sleep apnea and snoring, announces it has applied to the Helsinki Committee for approval to begin its planned clinical trial on the SleepX PRO application.
This follows the company’s recent update that it intends to test the SleepX Pro application at a hospital sleep lab. The trial is the first step towards applying for an FDA approval under the first-of-its-kind medical device category for contactless detection of sleep apnea to be performed through the Artificial Intelligence (AI) analysis of breathing during sleep. As the request is submitted under a medical device category and the trial is touchless, the company expects the process to be quick and take up to a few months.
SleepX Pro which is designed to diagnose sleep apnea using only a smartphone, requiring no physical contact with the subject. The global sleep apnea devices market size is valued at USD 3.7 billion as of 2020 with a 6.2% CAGR, reaching USD 6.1 billion by 2028, according to Grand View Research’s report.
“Poor sleep is associated with the compromised immune system, heart problems, reduce physical and mental performance, mood problems, obesity and many other health problems”, said Neil Kline, Founder & former CEO of the American Sleep Association, and a SleepX Board Member. “Unfortunately, most people with sleep disorder breathing problems, like sleep apnea, are undiagnosed and untreated. Our goal in this unique technology is to raise the awareness to the problem and to improve people’s awareness that they can live healthier and more fulfilling lives.”
“SleepX PRO makes for a unique, quick and friendly diagnosis tool that will prevent subjects from having to spend nights at sleep labs while saving the healthcare system and insurance companies hundreds of millions of dollars”, said Boris (Bary) Molchadsky, President and CEO of SleepX, and Chairman at AppYea. “We plan to make our diagnosis solution highly accessible, so people get tested easily.
SleepX is an Israeli research and development company recently acquired by AppYea. The company had developed a unique product for monitoring and treating sleep apnea and snoring. The technology is protected by several international patents and the company plans to start serial production in 2022. The company currently focuses its activities on the development and commercialization of its flagship product DreamIT.
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