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Wednesday, June 29, 2022

REMSleep Holdings Inc (OTCMKTS: RMSL) Heating Up as Co Awaits FDA Decision on DeltaWave & Looks to Up List to Fully Reporting OTCQB

EMSleep Holdings Inc (OTCMKTS: RMSL) continues to move steadily higher in recent trading surpassing $0.03 on increasing volume. While the overall markets have been weak, RMSL continues to be strong, is under heavy accumulation and is quickly attracting legions of new shareholders who are bidding RMSL higher. Management has been working hard behind the scenes with its securities attorney to gather information and complete an application to apply for OTCQB tier designation.  The Company also has a 510(k) submission for its DeltaWave CPAP MASK with the FDA and expects a decision in the next 2 weeks. RMSL has a fast-growing shareholder base; ready liquidity and the $0.048 highs of summer 2021 in its sights, a break over and its blue skies ahead for RMSL. 

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RMSL is making big moves recently securing an agreement with an overseas manufacturer for the import of 1500 nasal CPAP machines. REMSleep is currently building out a 10,000 square foot office warehouse in Largo, Florida that is recently leased. The new facility will help the company in its push to create more CPAP devices to alleviate the ongoing shortage. CPAP machines is also turning into a hot industry; according to online studies, 50 to 70 million adults in the United States have a sleep disorder and an estimated 22 million Americans are living with moderate to severe sleep apnea. With the current shortage of CPAP devices, the quality of sleep for so many individuals are being affected. 

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REMSleep Holdings Inc (OTCMKTS: RMSL) is a medical device manufacturer dedicated to forever changing the level of treatment provided to obstructive Sleep Apnea patients. The Company’s 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. RMSL diligently strive for our products to make the difference and improve the condition of those suffering from Sleep Apnea. 

The Company makes a number of products related to apnea including its FDA approved CPAP Masks which stop people from snoring while sleeping; REMSleep recently negotiated an agreement with an overseas manufacturer for the import of 1500 nasal CPAP machines. The devices will be ready in mid-April, with a large quantity of additional units being delivered in the months to follow. The United States has been experiencing a major shortage of availability for CPAP machines. This occurrence has been due to a recent recall from a well-known manufacturer, as well as global supply disruption and congestion, leaving many suffering from sleep apnea, quite alarmed. 

REMSleep is currently building out a 10,000 square foot office warehouse in Largo, Florida that is recently leased. The Company is aware that they will probably need to rent a much larger shipping warehouse later this year if the current CPAP shortage continues. The new facility will help the company in its push to create more CPAP devices to alleviate the ongoing shortage. To accommodate for the expected growth. The company is also looking to grow its staff as well as engage in a strong marketing campaign and website revamp for its product. 

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REMSleep Holdings NEW DeltaWave CPAP MASK is Uniquely Different proving a more comfortable anti snoring mask that allows for normal breathing. Recently submitting their 510k for the device, the Company worked hard to complete all the tests required by the FDA however they failed the retest due to what is believed to be a faulty analysis by the testing company. The company believes they can narrow down the exact part of the device that is failing the test and quickly resolve this matter. They have committed to a new third party lab to redo the test and provide results within the next few weeks. 

Last week RMSL responded to the Additional Information request pertaining to their current 510(k) application to the U.S. Food and Drug Administration (FDA) for its patented DeltaWave device, a nasal mask CPAP interface. The FDA’s acceptance of review of the 510(k) submission is a result of RemSleep’s years of development, research and design that has been invested into the DeltaWave. The product’s unique interface provides comfortable fit, less pressure and adequate air flow, which allows users to maintain a regular respiratory rate of 14 breaths per min while enjoying comfort and quietness. The DeltaWave matches the normal human respiratory rate with comfort and performance, which is critical, and because of that, we anticipate the DeltaWave to be a potentially major disruptor in the marketplace. The company anticipates receiving a decision from the FDA in approximately thirty days and will keep shareholders informed on all progress. 

CEO Tom Wood stated: “This submission is expected to be the final step and pivotal moment for our company. It will dramatically strengthen the commercialization of our brand and make the DeltaWave a premier product that reinforces our commitment to providing accessible, comfortable and quality care for so many who seek treatment for sleep apnea.” 

Sleep apnea is a potentially serious sleep disorder in which breathing repeatedly stops and starts. If you snore loudly and feel tired even after a full night’s sleep, you might have sleep apnea. According to online studies, 50 to 70 million adults in the United States have a sleep disorder and an estimated 22 million Americans are living with moderate to severe sleep apnea.

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Currently trading at a $43 million market valuation RMSL has a strong balance sheet with $2.3 million in the treasury and manageable debt of just over $1 million. Besides filling orders for its FDA approved CPAP Masks, the Company is currently building out a 10,000 square foot office warehouse in Largo, Florida to expand its production capacity and recently secured an agreement with an overseas manufacturer for the import of 1500 nasal CPAP machines. The Company has a 510(k) submission for its DeltaWave CPAP MASK with the FDA and expects a decision in the next 2 weeks. From a technical standpoint RMSL is getting interesting, currently under heavy accumulation the stock is moving steadily higher in great support and steady buying. We first put the word out on RMSL on April 18 when the stock was $0.013 in our article: “REMSleep Holdings Inc (OTCMKTS: RMSL) Getting Noticed as Co Fills Orders for its CPAP MASKs and Looks to get its new DeltaWave CPAP Approved We will be updating on RMSL when more details emerge so make sure you are subscribed to Microcapdaily so you know what’s going on with RMSL.

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Disclosure: we hold no position in RMSL either long or short and we have not been compensated for this article

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