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. After building operational systems, manufacturing capabilities, and distribution networks throughout 2025, the company enters the new year with what CEO Thomas Wood described as having all necessary pieces in place for proper operation.
The company recently submitted a supplemental 510(k) application to the FDA in early December, seeking to expand DeltaWave's indicated use beyond traditional CPAP therapy. The application requests clearance for use with BiPAP and other positive pressure ventilation devices, as well as approval for institutional single-patient use in hospital settings. According to operations manager Jeff Marshall, the original 510(k) clearance was overly conservative in focusing exclusively on home-use CPAP therapy, despite DeltaWave's core design features being potentially more valuable for patients on BiPAP or ventilation support. The supplemental filing leverages existing clearance and is being handled by a regulatory consulting firm that works with major manufacturers like Philips and ResMed. If approved, this expanded clearance would open institutional sales channels with higher price points than home care markets and position DeltaWave for clinical settings where pulmonologists and respiratory therapists make purchasing decisions.
REMSleep's go-to-market strategy for Q1 focuses on three distinct channels with different risk profiles and sales cycles. First, the company is targeting the 20-30% of new CPAP patients who fail their initial mask interface by positioning DeltaWave as a backup option when standard masks don't work. Second, internet provider partnerships are already showing progress, with two online CPAP retailers on their second and third orders after initial trials. Third, institutional sales will activate if the supplemental FDA application is approved, targeting hospital respiratory departments, long-term care facilities, and rehabilitation centers with longer sales cycles but bulk purchasing potential.
Rather than projecting explosive growth, REMSleep is focused on reaching what Marshall called a "float threshold" of 1,500-1,600 masks per month as an initial sustainable benchmark. At that volume, the company can maintain operations and continue funding product development without constant capital raises. Wood emphasized that the goal is to prove the business can operate, generate cash, and scale methodically rather than attempting to become a unicorn by March.
The company acknowledged that 2025 communications with shareholders were inconsistent, with Wood stating that being quiet while fixing problems created additional issues. REMSleep has committed to maintaining regular operational updates throughout Q1 with specific progress metrics rather than generic forward-looking statements. The company is exploring multiple paths to secure growth capital in Q1, including traditional private placements and strategic partnerships, with Wood noting that investors now want to fund traction rather than concepts.
REMSleep enters 2026 with infrastructure complete, initial market validation in hand, and a clear execution roadmap. The company expects Q1 to be a defining period that will determine whether four years of development work and investment were worthwhile. With the product and infrastructure established, the focus now shifts entirely to execution and proving commercial viability in competitive medical device markets. Additional information about the company is available at https://remsleep.com.
