REMSleep Holdings Inc. Issues Shareholder Letter

Rhea-AI Summary

REMSleep Holdings Inc. (OTCQB: RMSL) has announced its goal to capture 10% of the CPAP mask market within 24 months. The company recently received FDA approval for its DELTAWAVE Nasal Pillows System, which aims to address the high non-compliance rate in CPAP therapy users. REMSleep is focusing on the 36% of users who abandon CPAP therapy due to mask discomfort.

The company plans to intensify sales and marketing efforts, build relationships with key distributors, and educate medical professionals about their product's benefits. REMSleep also intends to conduct FDA clinical trials to confirm the effectiveness of their masks in alleviating COPD and CHF symptoms, potentially opening a new market. Their ultimate goal is to graduate to Nasdaq within the next 24 months.

Positive

• FDA approval received for DELTAWAVE Nasal Pillows System in July 2024
• Goal to capture 10% of CPAP mask market within 24 months
• Plans to conduct FDA clinical trials for COPD and CHF symptom relief
• Aim to graduate to Nasdaq within 24 months
• Increasing interest from distributors requesting product samples

Negative

• Currently trading on OTCQB, not yet on major exchanges
• Facing competition from well-funded, large companies in the CPAP market

Company Unveils Internal Corporate Goal of Capturing 10% of the CPAP Mask Market Within 24 Months

CLEARWATER, Fla., Aug. 06, 2024 (GLOBE NEWSWIRE) -- REMSleep Holdings, Inc. (OTCQB: RMSL), a leader in innovative sleep apnea products, published the following letter to shareholders.

Dear REMSleep Shareholders and Interested Investors:

Our company’s primary focus is two-fold. First, we are dedicated to providing high-quality products and experiences for CPAP therapy to support our customers and their families. Second, we are intensely focused on the significant market opportunity represented by the estimated 36% of people who abandon CPAP therapy due to mask discomfort. Of the entire market of CPAP therapy users, it is estimated that up to 50% become non-compliant within six months. Therefore, the 36% subset of the total non-compliant market, which is our initial target audience, represents a substantial opportunity.

People ask me all the time, “How can a small company compete with very large companies that are well funded?” The answer to that question is what places our company in such an enviable position. First, we don’t have to be their first choice for the mask (our mask is actually referred to as the DELTAWAVE Nasal Pillow System). All we have to be, is the choice that works. Second, the manufacturers of the CPAP machines want our masks to work. The CPAP market is a very unique market in that the mask wags the tail of the machine. If our mask works, that leads to more machines sales, more tubing sales, and more peripheral sales in general which ultimately builds the overall CPAP therapy market. Our masks ensure higher compliance rates for the machine manufacturers.

Our shareholders have seen some statistics about the CPAP market, but the true scale of this market is truly astonishing. CPAP machines are used to treat sleep apnea, so to understand the CPAP market, one must first consider the immense size of the sleep apnea market. In terms of its sheer scope, it ranks among the largest medical markets globally. Here are some key statistics to highlight this:

• According to the American Medical Association, it is believed that more than 30 million people have sleep apnea in the United States
• Only 6 million sleep apnea cases have been diagnosed in the United States
• It is estimated that 936 million people have obstructive sleep apnea globally
• It is estimated that between 1/3 and 1/2 of all people that start CPAP will quit within the next 12 months

As mentioned in our January 2023 shareholder letter, our goal was to obtain marketing clearance for our patented mask by submitting a 510(k) application to the United States Food and Drug Administration (FDA). To support this effort, we brought on Judy Strzepek as Senior Director for Regulatory Compliance and Regulatory Submission. Her extensive experience, collaboration with our new testing partner (specializing in respiratory class II medical device testing, cleaning, and validation), and deep understanding of FDA procedures were invaluable during the approval process. On October 6, 2024, we announced the submission of our 510(k) application to the FDA. The FDA responded with questions and requested additional testing, mainly focusing on the shelf life of our mask. It is with great pleasure and excitement that I can announce that our patented DELTAWAVE Nasal Pillows System received full marketing approval from the FDA in July 2024.

As a result of this approval, we now have a singular focus. We will rapidly build the sales of our DELTAWAVE Nasal Pillows System so that we can help patients and families improve their experience with CPAP therapy. We believe that our patented mask is one of the most important developments in the CPAP market to help sleep apnea patients since Philips Respironics debuted the first CPAP machine in the United States in 1985.

To the satisfaction of our shareholders, our company is now fully committed to aggressively pursuing a 10% market share of the CPAP mask market in the United States within the next 24 months. We are intensifying our sales and marketing efforts, focusing on building strategic relationships with carefully selected key distributors across major distribution areas in the country. A significant portion of our resources is dedicated to educating these distributors about the advantages of our mask over existing options. In tandem with this, we are also informing medical professionals about the benefits of our mask in comparison to other alternatives. Our core marketing message emphasizes three key points: First, our mask will enhance compliance rates among users who might otherwise discontinue CPAP therapy due to discomfort; Second, we aim to be the preferred secondary option if a patient discontinues their initial CPAP therapy. Third, we will ultimately be the first choice among CPAP users. Since we announced our 510K approval, we have received inquiries from distributors that are requesting product samples of our masks. As we receive the product sample requests, the outreach is coupled with a 4-step approach to rapidly expanding our products’ availability in the marketplace through an education of patients, distributors and medical professionals.

It is our goal to capture 10% of the overall mask market within the United States over the next 24 months. We believe this market goal is realistic based on our key marketing message. “We don’t have to be the first choice. However, we need to be the one that works”. It is important to focus on these key numbers. As many as 50% of all people that try CPAP therapy stop using their machines. Out of the 50%, 36% stop because of mask discomfort.

Our next-generation masks have demonstrated promising internal indications of relief for individuals suffering from Chronic Obstructive Pulmonary Disease (COPD) and/or Congestive Heart Failure (CHF), in addition to their sleep apnea. We expect and intend to conduct formal FDA clinical trials to confirm the effectiveness of REMSleep masks in alleviating COPD and CHF symptoms. At present, no CPAP masks on the market address these multiple conditions. Successful clinical trials will provide REMSleep with a competitive edge in a new market for traditional CPAP masks. This achievement will be a crucial step in showcasing the superiority of REMSleep products, enhancing sales, marketability, and overall profitability. From the outset, our goal has been to position the company for acquisition. Entering this new market should significantly increase REMSleep's overall value and create a sense of urgency for potential buyers. We are currently assessing potential hospitals and sleep centers to conduct these future studies.

Finally, it is important that I address the financial markets for a moment. Our goal of capturing 10% of the overall mask market in the next 24 months is real and achievable. As our shareholders know, we trade on the OTCQB. Our number 1 financial markets goal is to graduate to Nasdaq within the next 24 months. With our goal of capturing 10% of the overall mask market within 24 months, we certainly believe that Nasdaq is a short-term goal as opposed to a long-term dream.

We recognize that the key to achieving our goals is the support of our loyal shareholders. I am thankful for our board of directors who help govern our company with unparalleled dedication and guidance. As to the patients and families who will place their trust in our products in the past, now and in the future, we remain committed to helping you achieve a happier and healthier future.

Thank you,

Tom Wood
Chief Executive Officer
REMSleep Holdings, Inc.

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 a difference and improve the condition of those suffering from sleep apnea.

Forward-looking Statements

This press release may contain forward-looking statements regarding the Company. All statements, other than statements of historical fact included herein, are "forward-looking statements" including statements regarding the Company's future prospects and risks in investing in Company's common stock. These statements are based upon the Company's current expectations and speak only as of the date hereof. Financial performance in one period does not necessarily mean continued or better performance in the future. The Company's actual results in any endeavor may differ materially and adversely from those expressed in any forward-looking statements as a result of various factors and uncertainties, which factors or uncertainties may be beyond our ability to foresee or control. Other risk factors include the status of the Company's common stock as a "penny stock" and those risk factors stated in reports filed with the U.S. Securities and Exchange Commission or SEC on its EDGAR website (www.sec.gov)

Contact:

REMSleep Holdings, Inc.
14175 ICOT Blvd
Suite 300
Clearwater, FL 33760
Email: twood@remsleep.com

IR Contact:
Preya Narain
Info@preya.co
https://www.preya.co

FAQ

What is REMSleep Holdings Inc.'s (RMSL) main product?

REMSleep Holdings Inc.'s main product is the DELTAWAVE Nasal Pillows System, a CPAP mask that recently received FDA approval in July 2024.

What is REMSleep's (RMSL) market share goal for the next 24 months?

REMSleep Holdings Inc. aims to capture 10% of the CPAP mask market in the United States within the next 24 months.

When did REMSleep Holdings Inc. (RMSL) receive FDA approval for their CPAP mask?

REMSleep Holdings Inc. received FDA approval for their DELTAWAVE Nasal Pillows System in July 2024.

What percentage of CPAP users abandon therapy due to mask discomfort, according to REMSleep (RMSL)?

According to REMSleep Holdings Inc., 36% of CPAP users abandon therapy due to mask discomfort.

What additional medical conditions does REMSleep (RMSL) plan to address with their CPAP masks?

REMSleep Holdings Inc. plans to conduct FDA clinical trials to confirm the effectiveness of their masks in alleviating symptoms of Chronic Obstructive Pulmonary Disease (COPD) and Congestive Heart Failure (CHF).