REMSleep Holdings, Inc. has received Healthcare Common Procedure Coding System approvals from the Pricing, Data Analysis, and Coding contractor for its complete DeltaWave product portfolio. This development allows durable medical equipment providers to bill Medicare and private insurance payors for all configurations of the FDA-cleared nasal pillow system. The PDAC coding approvals represent the final regulatory requirement needed for REMSleep's full commercial launch. With expanded FDA 510(k) clearance granted on January 7 and full reimbursement coding now established, the company is positioned to begin nationwide distribution across home care, institutional, and sleep laboratory settings.
"This marks a critical milestone for our DME partners who now have everything they need—the expanded FDA clearance, HCPCS codes for all configurations, and a fully stocked inventory," said Thomas Wood, CEO and founder of REMSleep. The DeltaWave product portfolio expansion was informed by feedback from early adoption partners during REMSleep's Q4 2025 soft launch. DME providers and sleep laboratories identified specific component combinations and sizing variations required to better serve their patient populations. "Some providers prefer complete systems, while others need separate components tailored to their patient demographics," explained Jeff Marshall, REMSleep's operations manager. "Sleep labs also requested pillow-only options for diagnostic titration."
Since December 2025, REMSleep has achieved a series of key operational milestones including expanded FDA clearance, infrastructure buildout, and early market validation with zero product returns and repeat orders. "We have transitioned from a soft launch with a limited FDA clearance to being fully prepared for national distribution," Wood said. "This is a significant leap toward providing a complete solution for our customers." With regulatory and reimbursement barriers now cleared, REMSleep is activating its three-channel commercial strategy. The company will target DME providers serving the 20-30% of CPAP patients who fail their initial mask, establish sleep laboratory partnerships for diagnostic titration, and supply DeltaWave to hospital respiratory departments and long-term care facilities for use in BiPAP and ventilation support.
"We are now fully equipped to execute our strategy across multiple channels," said Marshall. "With all regulatory approvals in place, we are ready to move forward with our full-scale launch." This development matters because it removes the final barrier to widespread adoption of the DeltaWave system, potentially improving treatment options for patients who struggle with traditional CPAP masks. The implications include expanded access to alternative sleep apnea treatments, increased revenue opportunities for DME providers through insurance reimbursement, and potential market disruption in the sleep therapy equipment sector. The coding approvals validate the product's clinical utility and create a pathway for integration into standard care protocols across diverse healthcare settings.
