RemSleep Holdings Inc. Announces 510(k) Submission for DeltaWave
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.
- FDA 510(k) submission expected to strengthen commercialization of DeltaWave.
- DeltaWave offers a comfortable fit, adequate airflow, and matches normal respiratory rates.
- Potential market disruptor for sleep apnea treatment.
- Dependence on FDA approval timeline may introduce uncertainty.
Tampa, FL, May 06, 2022 (GLOBE NEWSWIRE) -- RemSleep Holdings Inc (OTC PINK: RMSL), a medical device manufacturer dedicated to forever changing the level of treatment provided to obstructive sleep apnea patients, today announced that the company has responded to the Additional Information request pertaining to their current 510(k) application to the U.S. Food and Drug Administration (FDA) for its patented DeltaWave device, a nasal mask CPAP interface.
“This submission is expected to be the final step and pivotal moment for our company. It will dramatically strengthen the commercialization of our brand and make the DeltaWave a premier product that reinforces our commitment to providing accessible, comfortable and quality care for so many who seek treatment for sleep apnea,” said CEO Tom Wood.
The FDA’s acceptance of review of the 510(k) submission is a result of RemSleep’s years of development, research and design that has been invested into the DeltaWave. The product’s unique interface provides comfortable fit, less pressure and adequate air flow, which allows users to maintain a regular respiratory rate of 14 breaths per min while enjoying comfort and quietness. The DeltaWave matches the normal human respiratory rate with comfort and performance, which is critical, and because of that, we anticipate the DeltaWave to be a potentially major disruptor in the marketplace.
The company anticipates receiving a decision from the FDA in approximately thirty days and will keep shareholders informed on all progress.
To learn more about how the unique design can improve performance, comfort, and rest, please visit our website and watch the DeltaWave product demo: https://remsleep.com/testimonials/
We encourage shareholders to visit our official Twitter account for further updates: https://twitter.com/RemsleepInc
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.
Forward-Looking Statements
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.
Investor Relations Contact:
Preya Narain
347-837-0626
info@preya.co
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