BLACKSHEAR, GA - January 30, 2026 (NEWMEDIAWIRE) - REMSleep Holdings, Inc. (OTCQB: RMSL), a developer of the FDA-cleared DeltaWave™ nasal pillow system, today 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 payors 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, REMSleep is poised 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. “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.”
Expanded Product Portfolio Reflects Customer Feedback
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 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.”
Timeline of Regulatory and Commercial Milestones
Since December 2025, REMSleep has achieved a series of key operational milestones:
- January 7, 2026: FDA 510(k) clearance expanded to include a wider patient demographic and multiple care environments.
- December 9, 2025: Supplemental 510(k) application submitted to the FDA.
- December 16, 2025: Infrastructure buildout, including ERP systems and sales force training, announced.
- December 23, 2025: Early market validation received, with zero product returns and repeat orders.
- January 21, 2026: Complete PDAC coding approval for all DeltaWave configurations.
“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.”
Commercial Strategy and Market Entry
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.
“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.”
About REMSleep Holdings, Inc.
REMSleep Holdings, Inc. (OTCQB: RMSL) is a medical device company focused on enhancing outcomes for patients requiring positive airway pressure therapy. The company’s DeltaWave™ nasal pillow system is FDA-cleared for use with CPAP, BiPAP, and other non-invasive positive pressure devices in both home and institutional settings. All DeltaWave products have received PDAC coding approval for Medicare and private insurance reimbursement.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements involve risks and uncertainties that could cause actual results to differ materially from those expressed or implied, including but not limited to: market acceptance of the DeltaWave system, DME provider adoption rates, the company’s ability to achieve targeted sales volumes, reimbursement practices by private payors, and general market conditions. REMSleep undertakes no obligation to update these forward-looking statements.
Contact:
Thomas Wood, CEO
REMSleep Holdings, Inc.
912-590-2001
twood@remsleep.com
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