Tampa, FL, November 08, 2022 — McapMediaWire — 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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