Tampa, FL , June 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 provides a corporate update and letter from CEO Tom Wood .
Dear Shareholders,
On Friday the 27th of May, we were informed by the FDA after months of waiting, the DeltaWave will be reclassified under 510K review as an implantable device. Consequently, additional testing is now required under this new classification. Management was advised to withdraw the current 510K application and resubmit after the new testing parameters have been satisfied. RemSleep is presently engaging the professionals perfectly suited to perform all new testing requirements and will fast-track this new requirement to submit the new 510K without delay. RemSleep has written acknowledgment from the FDA reviewer that all the testing submitted to date will be applicable to the new 510K submission. We worked diligently to comply with all known requirements to ensure that the current submission was accurately prepared, but due to the recent CPAP-related recalls, and other various complaints, DeltaWave’s 510K status has been an evolving, fast-moving target within the FDA.
Regardless, RemSleep takes full responsibility for all issues. Frankly, RemSleep is in a stronger position because in previous submissions we were not provided definitive guidelines. The last correspondence we received from the reviewer was accompanied with information providing a definitive guideline of requirements that we are now aware must be met to satisfy this new classification. This, along with a guarantee that all current test results are admissible, leaves us optimistic, since we are now proceeding without the previous uncertainties. Although disheartened by this setback, we expect to get this new 510K submission approved in a timely manner, and subsequent 510K submissions should go through the validation process much easier. Simultaneously we are planning to soon submit the next 510K on our next-generation Nasal Pillows interface, which we believe will be the new standard of world-class.
Our OTCQB application status is in the final stages of being completed by our securities attorney.
We will continue to update our shareholders. We understand your frustrations, and thank you for your patience during this time
NEVER ARGUE WITH STUPID PEOPLE. THEY WILL DRAG YOU DOWN TO THEIR LEVEL AND BEAT YOU WITH EXPERIENCE.” - Mark Twain
