Tampa, FL, Nov. 08, 2022 (GLOBE NEWSWIRE) -- RemSleep Holdings Inc. (OTCQB: RMSL), a medical device manufacturer dedicated to forever improving the level of treatment provided to obstructive Sleep Apnea patients, is pleased to announce that the expected last battery of testing will commence this week for final FDA submission of the company’s signature DeltaWave mask.
The series of additional tests that were identified in the prior GXP analysis are expected to take approximately 14-18 weeks to complete including a toxicologist opinion and final submission preparation. The tests will be conducted by our previously announced lab partner and supervised by our Senior Director for Regulatory Compliance, Judy Strzepek. In addition to final testing for the DeltaWave, RemSleep continues to pursue patent rights for the previously mentioned new masks and are investigating future clinical trial parameters to determine efficacy for the treatment of COPD and CHF.
As previously discussed, the company has had a number of triumphs and setbacks.
“We again faced an unforeseen obstacle that prevented starting this battery of tests in the expected timeframe which subsequently resulted in the delayed communication. Particularly, the GXP analysis identified an issue around proper ISO testing protocols mandating that the testing device must be received by the 3rd party testing company in the original, unopened manufacturer packaging, just as consumers would expect to receive while purchasing off the shelf. This protocol was just one of several key deficiencies that were not identified by our previous FDA 510K submitter, and the company was made aware by Ms. Strzepek and the new testing lab while conducting the GXP analysis,” said Tom Wood, CEO.
Because of this oversight, the company had to source, manufacture, and ship new inventory in addition to designing, printing, and assembling new packaging for final assembly specifically labeled for FDA testing. This was inexpensive but time consuming in the design, manufacturing, and shipping for all parties involved. The delay was further exasperated by several national holidays and Covid lockdowns that affected our third-party manufacturer. As a result of these delays, the company concurrently explored using a U.S. based third-party manufacturer for the trial packaging and subsequent ramp up to commercial production.
While the company is continuing to evaluate U.S. based manufacturing for commercial ramp up and production in the future, in the interest of expediency, we remained with the current supplier for this trial run. Finally, the company lost almost a week to secure vital information and inventory due to mandatory evacuation orders of our office and staff with the expected impact of the Tampa area by Hurricane Ian.
Due to missing past, self-imposed deadlines where the company was not in direct control of the outcome, and once again having the timeframe in the hands of a 3rd party; we chose to not provide an update until the product was in hand at the partnered testing lab and a timeframe could be firmly established.
We will provide regular updates over the final testing phase. The company understands that this is a difficult time for investors and sincerely appreciates the patience exhibited, the suggestions and concerns our investors have provided throughout, and the continued enthusiasm displayed for RemSleep.
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
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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
info@preya.co
