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 regulatory milestone allows durable medical equipment providers to bill Medicare and private insurance payors for all configurations of the company's FDA-cleared nasal pillow system, representing the final requirement needed for a full commercial launch.
The PDAC coding approvals follow expanded FDA 510(k) clearance granted on January 7, 2026, which included a wider patient demographic and multiple care environments. According to CEO Thomas Wood, this combination of regulatory achievements provides DME partners with everything needed for commercial distribution, including expanded FDA clearance, HCPCS codes for all configurations, and fully stocked inventory. The company is now positioned to begin nationwide distribution across home care, institutional, and sleep laboratory settings.
REMSleep's product portfolio expansion was informed by feedback from early adoption partners during a Q4 2025 soft launch. DME providers and sleep laboratories identified specific component combinations and sizing variations required to better serve diverse patient populations. Operations manager Jeff Marshall explained that some providers prefer complete systems while others need separate components tailored to their patient demographics, with sleep laboratories requesting pillow-only options for diagnostic titration. This customer feedback was integral in shaping the final product offering available at www.newmediawire.com.
The company has achieved a series of operational milestones since December 2025, including infrastructure buildout with ERP systems and sales force training announced on December 16, 2025, and early market validation with zero product returns and repeat orders by December 23, 2025. Wood stated that the company has transitioned from a soft launch with limited FDA clearance to being fully prepared for national distribution, representing a significant leap toward providing a complete solution for customers.
With regulatory and reimbursement barriers cleared, REMSleep is activating a three-channel commercial strategy. Sales representatives are reaching out to DME providers targeting the 20-30% of CPAP patients who fail their initial mask, with all billing codes now in place to support this market. The company will also partner with sleep laboratories to make DeltaWave available for diagnostic titration, ensuring patients can access the same mask through insurance after their lab visit. Additionally, institutional sales will supply DeltaWave to hospital respiratory departments and long-term care facilities for use in BiPAP and ventilation support.
This development matters because it removes significant financial barriers for patients requiring sleep therapy. With Medicare and private insurance reimbursement now available, more patients can access the DeltaWave system without substantial out-of-pocket expenses. For the sleep therapy industry, this approval enables broader adoption of an alternative nasal pillow system that addresses specific patient needs identified during early market testing. The nationwide distribution across multiple healthcare settings could potentially improve treatment outcomes for patients who have struggled with traditional CPAP masks, particularly those in the 20-30% failure rate segment targeted by REMSleep's commercial strategy.
