REMSleep Holdings, Inc. manufactures medical devices to treat obstructive sleep apnea, including via continuous positive airway pressure (CPAP) therapy. REMSleep Holdings manufactures and sells CPAP masks, machines, parts and accessories under several brands. REMSleep is a Florida-based corporation with a market capitalization of approximately $748,812 as of November 18, 2020. REMSleep’s shares are listed and sold under the symbol RMSL through the over-the-counter (OTC) Pink market. REMSleep Holdings Inc. has a 52-week high and low share price of $0.0022 and 0.0368, respectively. As of November 19, 2020, REMSleep’s shares were exchanging at $0.00185/share.
According to the American Sleep Apnea Association, an estimated 22,000,000 Americans suffer from sleep apnea. As many as 80% of cases of moderate to severe apnea may go undiagnosed. On November 19, 2020, REMSleep updated the timeline for certain bio testing and regulatory requirements relating to its Deltawave Nasal Pillow Mask, also called its DeltaWave Nasal CPAP Interface. REMSleep’s new product is intended to provide greater and more efficient air movement with the requirement for less pressure than other devices.
REMSleep announced that it has initiated bio testing requirements for the DeltaWave Nasal CPAP Interface and expects to have completed those tests by the end of December 2020. With the results of the completed testing in hand, REMSleep will file a premarket submission to the Food and Drug Administration under s. 510k of the Federal Food, Drug, and Cosmetic Act. The submission is required to establish that REMSleep’s DeltaWave Nasal CPAP Interface, because intended for human use, is as safe and effective as a legally marketed device.
REMSleep anticipates entering the market with its new product in the first quarter of 2021 and reports that discussions with potential national distributors are underway. The November 11, 2019 update of this schedule was required due to additional environmental regulatory testing which delayed originally the initial arrival of the new product to market.