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 expanded FDA 510(k) clearance secured on January 15 and Medicare PDAC coding approval for every product configuration on January 21, completing the regulatory requirements for nationwide distribution.
The company has been building infrastructure since December 2025, activating enterprise ERP systems, deploying a nationwide independent sales force across 48 states, and receiving product inventory. Early adopting DME partners reported zero-return, repeat-order results during a soft launch phase. The expanded FDA clearance broadened DeltaWave's indicated use to BiPAP, institutional settings, hospitals, long-term care facilities, and sleep labs.
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 significant clinical challenge: patients who feel less pressure effects tend to stay on therapy longer. The full commercial portfolio includes a Starter Kit with all three nasal pillow sizes, Single Pillow Systems for resupply, Nasal Interface without headgear, and a complete accessories suite.
This launch addresses a persistent problem in sleep medicine where 30 to 50 percent of patients prescribed CPAP therapy abandon it within the first year, with mask discomfort consistently cited as a primary reason. DeltaWave positions itself as a rescue mask alternative, giving DME providers a clinically differentiated option when standard formularies fail. The expanded clearance opens institutional channels including hospitals, long-term care facilities, rehabilitation centers, and sleep labs that weren't accessible under the original 510(k) language.
Thomas Wood, CEO and Founder, stated that after years of personally funding the product through FDA processes, patents, and clinical testing, the company is now launching with infrastructure ready and market need established. He emphasized that DeltaWave was designed from inception to provide patients with a more comfortable breathing experience to improve therapy compliance.
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 half of 2026.
