ResApp Health Ltd (ASX: RAP) shares are edging higher today after the company updated the market on its recent meeting with the United States Food and Drug Administration (FDA) for SleepCheck. In the minutes after market open, the ResApp share price reached an intra-day high of 9.3 cents but have partially retreated. At the time of writing, the ResApp share price is trading 2.22% higher at 9.2 cents.
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What's driving the ResApp share price?
The ResApp share price is on the move today after the company advised it has received a clear path to gain regulatory approval for its SleepCheck app to be used in the United States.
ResApp will pursue a 510(k) regulatory pathway for SleepCheck as a prescription only device. The 510(k) approach is the fastest route to market and relies on prior clearance that was granted for a predicate device.
The company stated that it plans to commence a human factors study in the United States beginning the third quarter of FY21. A human factors study employs representatives to assess the product's user interface design. The study requires a minimum of 15 people to run and is much shorter and cheaper than traditional clinical studies. ResApp in the past has carried out similar studies in Australia.
The 510(k) application is scheduled to be submitted at the end of the third quarter of FY21, with a decision from the FDA due 90 days after.
If successful in attaining the 510(k) clearance, ResApp will move to the next steps of making SleepCheck available to consumers, through a telemedical visit. Healthcare providers would conduct a virtual consultation and prescribe SleepCheck to sleep apnoea suffers. A specific code will be given out to patients allowing them to download SleepCheck from the Apple Inc (NASDAQ: AAPL) store or Alphabet Inc's (NASDAQ: GOOGL) (NASDAQ: GOOG) Google Play store.
What is SleepCheck?
SleepCheck is direct-to-consumer mobile application that assesses a person's risk of obstructive sleep apnoea by analysing their breathing and snoring. It requires no accessories or hardware other than the user's smartphone to make an assessment.
It is estimated that 42 million American adults suffer from sleep disordered breathing (SDB). This includes three in ten men and almost one in five women who possibly have sleep apnoea. Current predictions suggest around 75% of SDB cases remain undiagnosed.
Other developments
As part of its announcement, ResApp also reported it has received advice on the requirements to progress its over-the-counter (OTC) approval. The FDA stated that this process will entail further clinical and human factors studies to support its application. In response, ResApp will seek to commence a US laboratory-based clinical study during the fourth quarter of FY21.
The company will provide further updates in the coming months including the broader application's progress.
What did management say?
ResApp CEO and managing director, Dr Tony Keating, commented on the meeting. He said:
We expect to commence the US human factors study in beginning of next year. The study will be short and cost-effective, and will provide the required data for our 510(k) submission. ResApp will also move forward with the US clinical study needed for OTC approval of the product.
Sleep apnoea is a major health concern in the US, exacerbated by a large number of undiagnosed cases. SleepCheck would provide a low cost, easily accessible screening tool that could potentially reduce the health and economic impact of an increasingly common respiratory condition.
