REMSleep Holdings, Inc., developer of the FDA-cleared DeltaWave CPAP mask system, has outlined its commercial strategy for the first quarter of 2026 as the company shifts from building operational infrastructure to active market execution. CEO Thomas Wood stated that after spending 2025 establishing systems, manufacturing capabilities, and distribution networks, all necessary components are now in place for proper commercial operation.
The company's strategy centers on an expanded 510(k) application submitted to the FDA in early December, which seeks to broaden DeltaWave's indicated use beyond traditional CPAP therapy. The supplemental 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. Operations manager Jeff Marshall noted that the original 510(k) clearance was overly conservative, focusing narrowly on home-use CPAP therapy despite DeltaWave's design features being potentially more valuable for patients requiring 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, the 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. This regulatory development is detailed in the company's communications available at https://www.newmediawire.com.
REMSleep's go-to-market approach for Q1 focuses on three distinct sales 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 when standard masks don't work for DME/HME providers. Second, REMSleep is expanding partnerships with internet-based CPAP retailers who operate outside traditional reimbursement constraints and can move faster on product adoption. Third, pending FDA approval of the expanded application, the company will activate outreach to hospital respiratory departments, long-term care facilities, and rehabilitation centers, though this channel requires longer sales cycles.
Rather than projecting explosive growth, REMSleep is focused on reaching sustainable monthly unit volumes that generate sufficient cash flow to support operations. The company is targeting 1,500-1,600 masks per month as an initial benchmark, which would allow it to maintain operations and fund product development without constant capital raises. Wood emphasized that reaching this volume by the end of Q1 would fundamentally change conversations about the company's future trajectory.
Wood acknowledged that 2025 communications with shareholders were inconsistent, with an October press release suggesting the company was further along than reality and subsequent months of silence while management addressed operational challenges. The company has committed to maintaining regular operational updates throughout Q1 with specific progress metrics rather than generic forward-looking statements. Additional information about the company's products and strategy can be found at https://remsleep.com.
REMSleep is exploring multiple paths to secure growth capital in Q1, including traditional private placements and strategic partnerships. Wood noted that investors now want to fund traction rather than concepts, making Q1 execution critical for shifting capital conversations from risk assessment to opportunity participation. The company enters 2026 with infrastructure complete, initial market validation established, and a clear execution roadmap that will determine whether four years of development work will translate into commercial success.
