TAMPA, Florida—RemSleep Holdings Inc., a medical device manufacturer dedicated to treatment provided to Obstructive Sleep Apnea (OSA) patients, provided an update on its testing protocol for 510K clearance of its DeltaWave CPAP Mask as well as developments for its next-generation masks which it said has shown internal indications of relief from those suffering with certain comorbidities in conjunction with their sleep apnea.
The company previously announced DeltaWave testing was targeted to be completed in 14-18 weeks prior to submission for 510K clearance. The original timeline put the target towards mid to end of March of this year. After further review and discussion with the company’s partnering lab and compliance director, the timeline has been extended seven to eight weeks. One of the lengthier tests in the protocol (Cytotoxicity) had been restarted roughly halfway through the testing process due to a contaminated sample. The source of contamination could not be identified but it was determined to not come from the mask itself. Out of caution for any impact on the final results, the test was halted, and a new test started with a sealed DeltaWave sample from the original sample batch provided to the testing lab.
The current test is on track to be completed towards the middle to end of May as previously announced on the company's Twitter feed. RemSleep Holdings said there was no product failure in the test; rather, it was procedurally driven due to an observation of contamination once the test had already begun. While these issues cannot be foreseen and every step is taken to prevent them, it is also standard practice to provide additional, sealed samples for testing in an event such as this. While the delay was unexpected and frustrating, preparing for the possibility ahead of time resulted in the delay being relatively minimal.
The company recently announced a new test is being run in addition to those in the original protocol. The additional test was deemed prudent due to the ongoing recalls and scrutiny in the CPAP industry and to alleviate any potential concerns going forward based on these ongoing changes. However, due to the lengthier Cytotoxicity test being restarted, the additional test will have no impact on the May timeframe. To date, all completed tests have provided the results as expected and the company remains confident the remaining tests will show similar results. Once these tests have ended, the company expects it will take three to six weeks for risk management assessments to be completed, third party certification of toxicology results and final compilation to submit to the FDA for 510K clearance.
The company said it recently received positive news on its next-generation DeltaWave masks with respect to design and performance. RemSleep believes this provides significant support to the design being unique for respiratory masks and ultimately what the company considers to be the pathway for relief for those aforementioned sufferers. The company continues to evaluate medical centers &andsleep study centers to perform tests and trials demonstrating relief from a clinical standpoint. RemSleep believes the potential for these masks to compete in the institutional and residential spaces will position the company in a much better position strategically and financially over DeltaWave alone.
As the company previously discussed in the shareholder letter at the beginning of the year, CPAP device sales continue to be a focus. While RemSleep had several promising commitments early on that started the initiative and fell through, the last several months have shown several new sales channels opening up with orders being taken. While equipment sales are important for revenue and cash flow, ultimately the company is looking at sales of these devices to establish new sales channels and relationships to partner with once the DeltaWave line of masks are cleared.
“Obviously the stopping and restarting of a critical test is frustrating as a CEO, shareholder and a product designer," RemSleep CEO, Tom Wood, said. "The regulatory landscape has changed dramatically since the last product I brought to market and the increased scrutiny of respiratory devices and masks in general certainly isn’t making it any easier. While frustrating, it also reaffirms the decision we made to hire Ms. Strzepek with her specific, regulatory experience with respiratory masks, to oversee the 510K process. She remains invaluable to navigating this fluid environment and addressing any issues ahead of time that could be cause for concern on the administrative and procedural processes. Despite these challenges, I have never been more confident or excited for the impact I believe RemSleep can have on the market with the DeltaWave as well as the next-generation devices as we near the end of the testing process. It can be a difficult balance trying to share that confidence and excitement while dealing with the day-to-day issues, delays and waiting, but I hope that passion we must make these products successful continues to be seen and understood by our shareholders.”
The company will continue to update investors as information becomes available and is confirmed. RemSleep appreciates the ongoing questions and interest in the DeltaWave products and will follow up accordingly in press releases, on the company website: remsleep.com, and through the company Twitter feed: @RemsleepInc.
