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 development to active commercial execution. Following a 2025 period dedicated to building operational systems, manufacturing capabilities, and distribution networks, the company now aims to deploy these assets in the marketplace.
A central component of the Q1 strategy is an expanded 510(k) application submitted to the FDA in early December. The supplemental application seeks to broaden the DeltaWave's indicated use beyond traditional CPAP therapy to include compatibility 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. Jeff Marshall, REMSleep's operations manager, noted that the mask'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, and the company expects an FDA response by early to mid-January. Approval would open institutional sales channels with higher price points and position the product for clinical settings where pulmonologists and respiratory therapists influence buying decisions.
The company's go-to-market strategy for the quarter focuses on three distinct sales channels. First, it is targeting Durable Medical Equipment and Home Medical Equipment providers by positioning the DeltaWave as a "rescue mask" for the 20-30% of new CPAP patients who fail their initial mask interface, offering it as a backup option rather than seeking to overhaul primary formularies. Second, REMSleep is expanding partnerships with internet-based CPAP retailers, with two online providers already on repeat orders. These distributors operate outside traditional reimbursement constraints and can adopt products more rapidly. Third, pending FDA approval of the expanded application, the company will activate outreach to institutional markets like hospital respiratory departments, long-term care facilities, and rehabilitation centers. This channel involves longer sales cycles but offers potential for bulk purchasing and reduces dependence on insurance reimbursement complexity.
Rather than projecting explosive growth, management is focused on reaching a sustainable "float threshold." The company is targeting 1,500-1,600 masks per month as an initial benchmark, a volume that would generate sufficient cash flow to support operations and fund continued product development without constant capital raises. CEO Thomas Wood emphasized the goal is to prove the business can operate, generate cash, and scale methodically, which would fundamentally change conversations about the company's future.
Reflecting on 2025, Wood acknowledged that shareholder communications were inconsistent, with an October press release suggesting the company was further along than reality, followed by months of silence as management addressed operational challenges. 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 aim of creating enough market traction to make the company an attractive investment.
With infrastructure complete and initial market validation in hand, REMSleep views Q1 2026 as a defining period. The company has spent years and significant resources developing its product and operational foundation. The coming quarter will test whether that groundwork translates into commercial execution and sustainable business operations. Further information can be found on the company's website at https://remsleep.com.
