REMSleep Transitions to Commercial Execution with Expanded FDA Application and Three-Pronged Market Strategy

REMSleep Holdings, Inc., developer of the FDA-cleared DeltaWave CPAP mask system, has provided a strategic outlook for Q1 2026 as the company transitions from foundational infrastructure work to full commercial execution. CEO Thomas Wood stated that after building operational systems, manufacturing capabilities, and distribution networks in 2025, all the pieces are finally in place to run the business properly. The company now outlines how its assets, including a 20-person nationwide sales force and enterprise inventory systems, will be deployed in the first quarter.

A key element of the strategy is an expanded 510(k) application submitted to the FDA in early December. This supplemental application seeks to expand DeltaWave's indicated use beyond traditional CPAP therapy to include use with BiPAP and other positive pressure ventilation devices, as well as approval for institutional single-patient use in hospital settings. The original clearance was narrowly focused on home-use CPAP therapy, which excluded COPD patients on non-invasive ventilation and hospital applications. Operations manager Jeff Marshall noted that the original filing was overly conservative, emphasizing that DeltaWave's core design features, especially CO2 rebreathing reduction, are arguably more valuable for patients on BiPAP or ventilation support. The application is being handled by a regulatory consulting firm that works with major manufacturers like Philips and ResMed, with a response expected by early to mid-January. If approved, this expanded clearance opens institutional sales channels with higher price points and positions DeltaWave for clinical settings where pulmonologists and respiratory therapists make buying decisions.

REMSleep's go-to-market strategy for Q1 focuses on three distinct channels. First, the company is targeting the 20-30% of new CPAP patients who fail their initial mask interface, positioning DeltaWave as a backup option for DME providers when standard masks don't work. Second, internet provider partnerships are expanding, with two online CPAP retailers already on repeat orders after initial trials, and discussions underway with additional internet-based distributors. Third, pending FDA approval, institutional sales will target hospital respiratory departments, long-term care facilities, and rehabilitation centers, offering bulk purchasing potential despite longer sales cycles. The company is targeting 1,500-1,600 masks per month as a sustainable benchmark to generate sufficient cash flow to support operations while broader initiatives develop. Wood emphasized that the goal is not explosive growth but proving the business can operate, generate cash, and scale methodically.

Reflecting on 2025, Wood acknowledged inconsistent communications with shareholders and learned that being quiet while fixing problems creates more issues. The company has committed to maintaining regular operational updates throughout Q1 with specific progress metrics. Regarding capital strategy, REMSleep is exploring multiple paths to secure growth capital, including traditional private placements and strategic partnerships, with the focus on creating enough traction to shift the conversation from risk to opportunity. The company enters 2026 with infrastructure complete and initial market validation, expecting Q1 to be a defining period that determines whether years of work were worth it. For more information, visit remsleep.com.