BLACKSHEAR, Georgia—REMSleep Holdings, Inc., a developer of the Food & Drug Administration-cleared DeltaWave nasal pillow system, announced that it has received Healthcare Common Procedure Coding System (HCPCS) approvals from the pricing, data analysis and coding (PDAC) contractor for the entire DeltaWave product portfolio. This approval allows durable medical equipment (DME) providers to bill Medicare and private insurance payers for all configurations of the DeltaWave 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 in place, REMSleepsaid it is now poised to begin nationwide distribution across homecare, 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. “We are excited to proceed with the full commercial launch of DeltaWave, offering a solution that meets the diverse needs of the sleep therapy market.”
REMSleep said the DeltaWave product portfolio expansion was informed by feedback from early adoption partners during REMSleep’s Q4 2025 soft launch. The company added DME providers and sleep laboratories identified specific component combinations and sizing variations that were 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. This feedback was integral in shaping the final product offering.”
With regulatory and reimbursement barriers now cleared, REMSleep is activating its three-channel strategy:
- DME/HME Rescue Mask Positioning: Sales representatives are reaching out to DME providers, targeting the 20-30% of CPAP patients who fail their initial mask. All billing codes are in place to support this market.
- Sleep Laboratory Partnerships: DeltaWave will be available for use in diagnostic titration, ensuring that patients can access the same mask through insurance after their lab visit.
- Institutional Sales: REMSleep will begin supplying DeltaWave to hospital respiratory departments and long-term care facilities for use in BiPAP and ventilation support.