RemSleep Holdings Inc. Provides a Shareholder Update
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.
- New distribution agreements for CPAP machines expected to increase sales.
- Devices are FDA approved and unaffected by the chip shortage.
- The company signed a three-year lease for a larger facility to support growth.
- Failed a cytotoxicity retest impacting FDA submission timeline.
- Dependence on third-party labs has caused delays in product testing.
Tampa, FL, March 28, 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, provides a corporate update to the company’s shareholders.
When submitting a 510k for a device such as the DeltaWave, there are a myriad of tests that need to be carried out to prove to the FDA that the device is safe and effective. The company has diligently carried out these tests through independent testing labs. There have been no issues aside from a negative result on a cytotoxicity test due to incorrect procedures performed by a third-party lab. This roadblock required the company to perform a retest. The company has failed the retest due to what is believed to be a faulty analysis by the testing company. The company believes they can narrow down the exact part of the device that is failing the test and quickly resolve this matter. They have committed to a new third party lab to redo the test and provide results within the next few weeks.
“From a new location, to staffing, to new distribution agreements, website updates, and working on our submission, we have been working around the clock on growing every aspect of our company. The failed test is not a result of management, we have run into a problem that we had not anticipated. 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 which we can share,” said CEO Tom Wood.
In the meantime, the company forges ahead with its new distribution agreement for CPAP machines. The company hopes to dramatically increase the quantities of devices received and sold in the near future.
The devices are FDA approved and compare very favorably both technically and overall in regard to the quality and their functionality. Additionally, the manufacturer of these devices has not been affected by the current chip shortage that the global markets have been experiencing. About eighty percent of the CPAP machines will be sold primarily to durable medical equipment dealers and distributors, with the balance being sold direct to consumer. RemSleep will be selling the machines to durable medical equipment dealers at the low end of the price range shown on the company’s website, while a price point for direct-to-consumer sales has not yet been established. In the near future, these machines will be paired with the DeltaWave mask. The company has tested the machine’s compatibility with the DeltaWave mask and has found that the pairing works beautifully.
The new three-year lease for the 10,000 square foot property is officially the company’s first facility. The company decided to enter this lease because their projections that they will need a larger facility going forward. If the current CPAP shortage continues, the company is aware that they will probably need to rent a much larger shipping warehouse later this year.
The company is currently working with its securities attorney to gather information and complete an application to apply for OTCQB tier designation. The corporate website is currently under development to reflect a series of changes with updates continuing daily.
“We are optimistic about our strategies going forward, to bring in revenues to our company, as well as aiming to submit our 510k using the extension granted through the FDA,” said Tom Wood.
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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