REMSleep Holdings, Inc. has announced the full commercial launch of its DeltaWave™ nasal pillow system across all U.S. distribution channels, including durable medical equipment companies and institutional sales. The launch follows the completion of regulatory prerequisites, including expanded FDA 510(k) clearance secured on January 15 and Medicare PDAC coding approval for every product configuration on January 21.
The company has been building infrastructure for this launch since December 2025, when enterprise ERP systems were activated and a nationwide independent sales force was deployed across 48 states. Early adopting DME partners reported zero-return, repeat-order results during a soft launch phase, validating market acceptance before the full commercial rollout.
The DeltaWave system features patented Direct Airflow Technology designed to reduce the pressure and airflow sensation patients experience at the nasal interface. This engineering approach addresses a persistent problem in sleep medicine: approximately 30 to 50 percent of patients prescribed CPAP therapy abandon it within the first year, with mask discomfort consistently cited as a primary reason.
The full commercial portfolio includes a Starter Kit containing all three nasal pillow sizes, Single Pillow Systems for resupply, Nasal Interface components without headgear, and a complete accessories suite. All configurations have received PDAC coding approvals, enabling DME providers to bill Medicare and private insurers for the products.
The expanded FDA clearance broadens DeltaWave's indicated use to include BiPAP machines, institutional settings, hospitals, long-term care facilities, and sleep labs. This expansion opens new distribution channels that were previously inaccessible under the original 510(k) language, potentially introducing the solution to patients at the beginning of their therapy journey.
Thomas Wood, CEO and Founder of REMSleep, stated that the product was designed to give patients a more comfortable breathing experience so they stay on therapy and actually benefit from it. The company's positioning of DeltaWave as a rescue mask alternative provides DME providers with a clinically differentiated option when standard formulary products aren't working for patients.
The DeltaWave Nasal Pillow System is available through REMSleep's direct sales channels. DME providers, physicians, and patients can visit www.remsleep.com for product specifications, pricing, and ordering information. The company will continue providing operational updates as commercialization develops through the first and second quarters of 2026.
This nationwide launch represents the culmination of a three-year build process for REMSleep, with all regulatory, infrastructure, and distribution elements now in place. The availability of DeltaWave across multiple care settings could potentially impact sleep therapy compliance rates by providing an alternative for patients who struggle with traditional mask interfaces. For DME providers, the product offers both clinical differentiation and established reimbursement pathways through Medicare and private insurance billing codes.
