REMSLEEP HOLDINGS INC - RMSL STOCK NEWS

RemSleep Holdings (OTC PINK: RMSL) has responded to the FDA's Additional Information request regarding its 510(k) application for the DeltaWave device, a nasal mask CPAP interface. This pivotal submission is expected to enhance the commercialization of the DeltaWave, known for its comfort and adequate airflow, potentially disrupting the sleep apnea market. The company anticipates an FDA decision in around 30 days and is committed to keeping shareholders informed on progress.

RemSleep Holdings (OTC PINK: RMSL) issued a corporate update highlighting challenges with its DeltaWave device's FDA 510k submission. The company failed a cytotoxicity retest due to faults by a third-party lab, prompting a commitment to retest with a new lab. Despite this setback, the company is advancing with new distribution agreements for CPAP machines, with FDA-approved devices unaffected by current chip shortages. They signed a three-year lease for a larger facility and are working towards OTCQB tier designation to enhance operations.

RemSleep Holdings (OTC PINK: RMSL) has secured an agreement with an overseas manufacturer to import nasal CPAP machines amidst a significant shortage in the U.S. A first order of 1,500 units is expected to ship by mid-April, with plans for presales to boost revenues. This move aims to alleviate the ongoing CPAP device scarcity resulting from recent recalls and global supply chain issues. To support growth, RemSleep is relocating to a larger facility and enhancing its marketing efforts. The company addresses the needs of the 22 million Americans suffering from sleep apnea.

RemSleep Holdings (OTC PINK: RMSL) announced a strategic partnership with Preya Co and MCAP Mediawire to enhance communication with shareholders and strengthen their outreach efforts. This move comes in anticipation of the expected DeltaWave 510k approval and market release, addressing the high demand from both the public and medical community. CEO Tom Wood emphasized the importance of maintaining open communication with investors to add value. Preya Co offers expertise in investor relations, while MCAP Mediawire provides robust news distribution services.

REMSleep Holdings, Inc. (OTC PINK: RMSL) announced that the FDA requires additional testing for its 510K submission regarding product development. The company plans to initiate testing promptly. Furthermore, proceeds from the Reg A offering will support ongoing product development, expected patent applications, and inventory buildup pending 510K approval. The press release also contains forward-looking statements highlighting risks, including the potential inability to secure financing and regulatory challenges that could affect business outcomes.

REMSleep Holdings, Inc. (OTC PINK: RMSL) has announced that its submission K212087 has passed the acceptance review. The submission was found to contain all necessary elements for a substantive review, and a lead reviewer has been assigned to the case. The company plans to provide further updates as they become available.

This announcement follows the regulatory protocol and demonstrates the company's progress in its submission process, which may have implications for future developments.

REMSleep Holdings, Inc. (OTC PINK: RMSL) has filed a 510K submission for its DeltaWave CPAP pillows interface mask. The submission, numbered K212087, was received on July 6, 2021. This marks a significant step for the company in advancing its product offerings in the sleep treatment market. The DeltaWave Nasal Pillows System aims to enhance patient comfort and efficacy in CPAP therapy. The press release includes forward-looking statements that caution against placing undue reliance on future projections and highlights potential risks associated with financing, competition, and regulatory matters.