Tampa, FL, September 1, 2023 – RemSleep Holdings Inc. (OTCQB: RMSL), a medical device manufacturer dedicated to forever changing the level of treatment provided to Obstructive Sleep Apnea (OSA) patients, provides an update on its testing protocol for 510K clearance of its DeltaWave CPAP Mask.
RemSleep has completed the testing protocol for 510K clearance and all tests have successfully passed including the Cytotoxicity and MLA tests which were the subject of past issues requiring retesting. The company previously provided an estimate of 3-6 weeks for compiling these results and has reduced that estimate to 2-4 weeks before submitting to the FDA for 510K clearance.
RemSleep CEO, Tom Wood, commented: “This is a substantial and critical milestone for RemSleep and the DeltaWave mask. It has taken significantly longer to get to this point than we had ever envisioned due to the unforeseen delays and administration issues, but in the end, the successful results demonstrate what we have confidently stated and believed from the start: the DeltaWave mask, and the materials used in the manufacture of the mask, are safe. It has been a frustrating road with so many issues coming out that were beyond our control, but the testing is over and we expect to submit to FDA before the end of September. During this extended time, we secured a design patent for the DeltaWave, made significant progress on the development of the next generation masks, and have continued to reach out to distributors and channel partners for the eventual product launch. While this has been a tough learning curve, we expect to be able to employ the knowledge gained to move our next generation masks through the clearance process and into the market significantly faster & with less expense.
We would like to thank our investors for their continued support and invite new investors to visit our website at www.remsleep.com for more information on how the DeltaWave goes beyond the normal sleep apnea mask for performance. There is an informational video on the key points of difference as well as testimonials from users and clinicians on what these PODs mean to real world sleep and productivity for DeltaWave users. Finally, for those still affected by the CPAP recalls and shortages, we have our ResPlus CPAP device available for purchase via our website.”
About RemSleep Holdings Inc.
RemSleep Holdings Inc. is a medical device manufacturer dedicated to forever changing the level of treatment provided to obstructive Sleep Apnea patients. Our focus is primarily designing and manufacturing devices and products for the treatment of Sleep Apnea and other respiratory conditions. With over 30 years of collective experience in CPAP therapy, the RemSleep team has extensive knowledge and understanding of CPAP and the challenges of patient compliance. We diligently strive for our products to make the difference and improve the condition of those suffering from Sleep Apnea. www.remsleep.com
Some statements in this release may contain forward-looking information. All statements, other than of historical fact, that address activities, events or developments that the Company believes, expects or anticipates will or may occur in the future (including, without limitation, statements regarding potential acquisitions and financings) are forward-looking statements. Forward-looking statements are generally identifiable by use of the words “may”, “will”, “should”, “continue”, “expect”, “anticipate”, “estimate”, “believe”, “intend”, “plan” or “project” or the negative of these words or other variations on these words or comparable terminology. Forward-looking statements are subject to a number of risks and uncertainties, many of which are beyond the Company’s ability to control or predict, that may cause the actual results of the Company to differ materially from those discussed in the forward-looking statements. Factors that could cause actual results or events to differ materially from current expectations include, among other things, without limitation, the inability of the Company to obtain sufficient financing to execute the Company’s business plan; competition; regulation and anticipated and unanticipated costs and delays, and other risks disclosed in the Company’s public disclosure record on file with the relevant securities regulatory authorities. No information in this press release should be construed as any indication whatsoever of the Company’s future revenues, results of operations or stock price. Although the Company has attempted to identify important factors that could cause actual results or events to differ materially from those described in forward-looking statements, there may be other factors that cause results or events not to be as anticipated, estimated or intended. Readers should not place undue reliance on forward-looking statements. The forward-looking statements included in this news release are made as of the date of this news release and the Company does not undertake an obligation to publicly update such forward-looking statements to reflect new information, subsequent events or otherwise unless required by applicable securities legislation.
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SOURCE: RemSleep Holdings Inc
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