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REMSleep's DeltaWave System Gains Early Traction as Sales Infrastructure Activates

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Early Adopting Customers Report Strong Retention, Repeat Orders; DME Distribution Network Preparing for Broader Rollout

REMSleep Holdings, Inc. (OTCQB:RMSL)

Most DMEs run tight formularies," Marshall explained. "We're not asking them to replace those. We're saying, 'When your patient comes back after 30 days, saying the mask doesn't work, try DeltaWave.”
— Jeff Marshall

BLACKSHEARS, GA, UNITED STATES, December 22, 2025 /EINPresswire.com/ -- REMSleep Holdings, Inc. (OTCQB: RMSL), developer of the FDA-cleared DeltaWave™ CPAP mask system, today reported initial market traction as the company's sales infrastructure moves from soft launch to active commercialization.

Following last week's announcement of completed operational infrastructure, REMSleep can now confirm that early market response is validating the product's core value proposition: patients who try DeltaWave tend to stick with it.

The numbers are still small. This isn't a victory lap, but they're telling. Two early adopting customers have placed multiple repeat orders after initial trials. One of those providers has now deployed approximately 70 DeltaWave units with zero returns reported. For context, mask fit failures are the leading cause of CPAP therapy abandonment, with studies showing 20-30% of new patients requiring a second mask within the first 90 days.

"Zero returns doesn't mean the sample size is conclusive," said Thomas Wood, CEO and founder. "But it does mean we're seeing the expected response that the product lives up to its’ brand promise.' Home Medical Equipment providers will not promote masks that have a high patient return rate."

**The Soft Launch Strategy:**

Since mid-October, REMSleep's 20-member sales force has been demonstrating DeltaWave to DME providers and sleep labs without aggressively pushing for large commitments. The strategy was deliberate: get the product into real-world use, gather feedback, and avoid overpromising before the full replacement parts ecosystem was ready.

That ecosystem is now in place. Replacement part inventory, comprised of five distinct SKU configurations, covering pillows, tubing, and headgear combinations, have cleared final manufacturing and are en route to U.S. fulfillment operations. Once received, customers will enjoy quick delivery with a minimum of 3 months of supply on the shelf, having the security that they can run their business model.

Additionally, REMSleep's applications for PDAC coding (Pricing, Data Analysis, and Coding) are progressing through the standard review process. These codes allow DME providers to integrate DeltaWave seamlessly into their existing ordering and insurance reimbursement systems. The company expects coding approval before year-end based on typical processing timelines.

**Rescue Mask Positioning:**

Jeff Marshall, REMSleep's operations manager, said the company is testing a specific go-to-market approach with promising early results: positioning DeltaWave as a "rescue mask" for patients who fail their initial CPAP interface.

"Most DMEs run tight formularies," Marshall explained. "We're not asking them to replace those. We're saying, 'When your patient comes back after 30 days, saying the mask doesn't work, try DeltaWave.' That's a much easier conversation than asking them to overhaul their workflow and supply chain."

Industry data suggests roughly 20% of new CPAP patients require a second mask within the first three months of therapy. Out of 1,000 new patients, over 200 of them will require mask replacements. If DeltaWave can capture even a fraction of that rescue market across the nationwide sales network, it will provide a foundation for growth.

**What's Changed Since October:**

The October 1 press release noted that sales representatives were "waiting for further instruction" while replacement parts were being manufactured. That waiting period is over.

The WinWeb ERP system went live last week, providing real-time inventory visibility, automated order processing, and full chain-of-custody tracking. Sales reps now have the tools to take orders, confirm delivery timelines, and provide DME customers with the documentation they need for compliance.

"October was aspirational," Wood said. "We thought we'd be further along. Turns out building a real medical device company takes longer than you think, even when you already have FDA clearance. The good news is we're not cutting corners to hit artificial deadlines anymore."

**Onshore Manufacturing Discussions Advancing:**

REMSleep continues working with a leading medical device manufacturer and distributor based in the US, on a potential agreement to handle U.S.-based assembly and warehousing. The arrangement would reduce per-unit shipping costs significantly by manufacturing DeltaWave close to our customers.

The teams continue to work closely on this project to ensure a best-in-class customer experience with a high focus on quality while scaling this large project. Once final agreements are in place, we expect to start scaling production within Q2 2026.

**Looking Ahead:**

With inventory systems operational, replacement parts arriving, and early adopters showing retention, REMSleep is positioned for what the company expects to be a more aggressive commercial push in Q1 2026.

The company is targeting monthly volumes in the 1,500-1,600 unit range as an initial sustainable threshold—enough to generate meaningful cash flow while broader marketing initiatives and distribution partnerships develop.

Next week's update will outline the company's Q1 strategy in more detail, including the expanded 510(k) application currently under FDA review and plans for direct-to-consumer sales channels.

**About REMSleep Holdings, Inc.**

REMSleep Holdings, Inc. (OTCQB: RMSL) is a medical device company focused on improving outcomes for patients requiring positive airway pressure therapy. The company's DeltaWave™ system is FDA-cleared and designed to address common compliance challenges in CPAP therapy through its patented interface technology.

**Forward-Looking Statements**

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements involve risks and uncertainties that could cause actual results to differ materially from those expressed or implied, including but not limited to: the timing of inventory deliveries, PDAC coding approvals, market acceptance of the DeltaWave system, the development of manufacturing partnerships, and the company's ability to achieve targeted sales volumes. REMSleep undertakes no obligation to update these forward-looking statements.

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