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 moves from building operational foundations to executing market plans. CEO Thomas Wood stated that after constructing systems throughout 2025, all necessary components are now in place for proper commercial operation. The company submitted a supplemental 510(k) application to the FDA in early December, seeking to expand DeltaWave's indicated use beyond traditional CPAP therapy to include BiPAP and other positive pressure ventilation devices, along with approval for institutional single-patient use in hospital settings. Operations manager Jeff Marshall noted that the original clearance was overly conservative, focusing narrowly on home-use CPAP despite design features that could benefit patients requiring more advanced 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. Approval would open institutional sales channels with higher price points and position DeltaWave for clinical settings where pulmonologists and respiratory therapists make purchasing decisions. REMSleep's go-to-market strategy focuses on three distinct channels with different risk profiles and sales cycles. First, the company targets DME/HME providers by positioning DeltaWave as a rescue mask for the 20-30% of new CPAP patients who fail their initial mask interface, with early tests showing provider receptivity. Second, internet provider partnerships are expanding with two online CPAP retailers already placing repeat orders after initial trials, allowing faster adoption outside traditional reimbursement constraints.
Third, pending expanded FDA clearance, institutional sales outreach would begin to hospital respiratory departments, long-term care facilities, and rehabilitation centers, offering bulk purchasing potential despite longer sales cycles. Rather than projecting explosive growth, management is focused on reaching a sustainable monthly volume of 1,500-1,600 masks, which Marshall described as a float threshold generating sufficient cash flow to support operations while broader initiatives develop. Wood emphasized that achieving this benchmark by quarter's end would fundamentally change conversations about the company's future trajectory. The company learned from 2025 communication challenges and has committed to regular operational updates with specific progress metrics throughout Q1.
Capital strategy involves exploring multiple paths including traditional private placements and strategic partnerships, with Wood noting that investors now want to fund traction rather than concepts. The company's job in Q1 is to create enough market traction to shift capital conversations from risk assessment to opportunity participation. With infrastructure complete and initial market validation established, Q1 2026 represents a defining period for determining whether years of development work will translate into commercial success. The company's regulatory efforts are detailed in their FDA submission available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm, while information about the DeltaWave system can be found at https://www.remsleep.com/products/deltawave-cpap-mask.
