REMSleep provides update on DeltaWave
By HME News Staff
Updated 11:42 AM CDT, Tue March 29, 2022
TAMPA, Fla. – REMSleep has engaged a new third-party lab to redo testing for its DeltaWave as part of the 510k process for the nasal CPAP interface. The company says it has received a negative result on a cytotoxicity test due to incorrect procedures performed by a previous lab and has failed a re-test due to a faulty analysis by a testing company. “The failed test is not a result of management; we have run into a problem that we had not anticipated,” said CEO Tom Wood. “While we like to keep our shareholders informed as much as possible and try to provide timelines as to when significant events will occur, a lot of those timelines are reliant on third parties working together cohesively to give us timely, accurate results that we can share.” REMSleep believes it can narrow down the exact part of the device that is failing the test, quickly resolve the matter and have results from the new lab within the next few weeks. In the meantime, the company continues to initiate new distribution agreements for its ResVent auto-titrating CPAP device, which it says has not been affected by the current chip shortage. It has also signed a three-year lease on a 10,000-square-foot property to accommodate growth.
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