RemSleep Holdings Inc. (OTCQB: RMSL), a medical device manufacturer dedicated to forever changing the level of treatment provided to Obstructive Sleep Apnea (OSA) patients, provides an update on its testing protocol for 510K clearance of its DeltaWave CPAP Mask as well as a correction on previous update on the Cytotoxicity testing.
It was previously announced the Cytotoxicity test was restarted due to contamination. That statement was incorrect. The Cytotoxicity test was started significantly later than was originally communicated to RemSleep and was scheduled to be completed mid to late May. The MLA (Mouse Lymphoma Assay) test was the test which experienced the contamination that had to be restarted once the contamination was identified and deemed to potentially compromise test results. The mid to end of May timeline remained valid for testing completion.
About a week ago, RemSleep was informed that the MLA test had once again shown signs of contamination towards the end of the test. The test sample was disposed of before RemSleep could determine the source, or origin of the contamination. At that time, rerunning the test would not represent a material shift in the timeframe due to the Cytotoxicity test starting later than what had previously been communicated to the company. This time, due to the second issue of contamination and remaining tests being completed, the sample was isolated and it was determined the contamination was from mold. Due to the nature of the testing, it is extremely difficult to locate the source of mold contamination. Furthermore, due to the nature of mold, it can develop quickly, whereas with this test it was found near the end and may have developed about midway through the test.
Both MLA tests were run by a contracted lab through our primary lab partner. This is due to our primary lab not having the equipment to run this specific test. This is one of two tests that were contracted to outside labs. It is critical to note that the remaining tests have all been run through our primary lab and there have been no contamination or handling issues in any other tests in the protocol. As previously noted, RemSleep went through a strict protocol in preparing the DeltaWave samples for this testing which involved preparing them in a clean room, sterile environment. Additional samples have been prepared for retesting and the company has taken an additional step of shrink wrapping the entire sample prior to shipping to ensure no contamination can be derived from the handling during the shipping process. FDA protocol directs the testing lab to test the unit in question directly from the packaging without any modification, cleaning, sterilization, etc. While RemSleep is confident the precursor to the mold development did not come from handling in the sample preparation at the company facility with the prior samples, this additional abundance of caution was taken to further rule out any possible source of contamination while the Deltawave was in company hands.
The Deltawave itself has passed all tests with no issues, so at the end of the day we know Deltawave will get past testing, of which there was never any doubt from the beginning. There was significant discussion about the impact the mold contamination had on the actual test results and moving forward with the MLA results for submission despite the contamination. In the end, there is no way to conclusively prove the mold contamination had no material affect (positive or negative) on the test results and the company was advised to rerun the test. While this will once again delay 510K submission, the successful test results minus the contamination issue validates the company’s assertion and/or belief that the DeltaWave is inherently safe due to the materials used. Along those lines, the company wants to iterate in no uncertain terms that all materials used in the design and manufacture of the DeltaWave device are Class VI Medical Grade and these materials are used safely by millions of Americans every day in FDA cleared devices throughout the US.
The company has prepared the new samples as noted above and have been shipped to the testing lab, which will be received by the testing lab 6/1/2023. The company has been assured the new test will take priority and will not be put into a que to start on a later date, which happened previously (with the Cytotoxicity test) resulting in an extended timeline. The company is waiting for confirmation on when the test will be started and how long it will take once started. Further, our primary lab is evaluating the handling of the test by the 3rd party lab to mitigate any chance of further mold contamination on their end. Based on previous notes provided to our primary lab on the original contamination, it is believed that the first test may also have been due to mold due to several similarities. While it is no comfort to the current situation, the company was informed this isn’t an unusual issue with this particular MLA test.
“Obviously we are extremely frustrated and disappointed by this second issue of contamination,” stated RemSleep CEO, Tom Wood. “The frustration is exasperated by not being able to ascertain the source or place where the contamination occurred. You do everything as advised in the handling of the sample products and still can’t be 100% sure. We took the additional steps in this latest sample and assume our partner lab will be able to further mitigate any potential issues on the contracted lab’s end and finally get the DeltaWave submitted for 510K clearance. On a positive note, the successful completion of all the remaining tests as well as no negative indications in the MLA test validate what we believed from the start of this very long process: the DeltaWave is safe as well as being effective. We were looking to expound upon the prior notice of RemSleep receiving the design patent for the DeltaWave along with successful completion of all tests. Now that we must repeat the MLA test again, this milestone accomplishment is clearly overshadowed. We are looking at formats for an investor call or interactive Q&A where we can go into more detail about how these events unfolded and answer investor questions. Further, we would like to provide more detail of the significance of the design patent and how it validates that the DeltaWave is truly unique and how the design aspects of the DeltaWave give us the results we have achieved. It is difficult to give depth into these issues in print. Once we get some of these questions on timeline answered, we will follow up with investors on a conference call or some type of interactive Q&A session format. It is frustrating, but shadows are not falling.”
Finally, while the retesting timeline is being finalized, it is expected to the original compilation timeframe that was provided will be shortened as much of that work can be performed while the RMA test is being rerun.
RemSleep appreciates the ongoing patience and understanding of investors and inherently understands the frustration and concerns of another setback. The company and will follow up accordingly in press releases, on the company Website: www.remsleep.com, and through the company Twitter feed: @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. www.remsleep.com
https://twitter.com/RemsleepInc
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Preya Narain
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