REMSleep Secures Medicare PDAC Coding for Full DeltaWave Nasal Pillow Line, Clearing Path for Nationwide Launch

BLACKSHEAR, Ga. — REMSleep Holdings, Inc. (OTCQB: RMSL) announced a major commercialization milestone after receiving Medicare approval for reimbursement coding across its entire DeltaWave™ nasal pillow product line. The approval, granted through the Pricing, Data Analysis, and Coding (PDAC) contractor, allows durable medical equipment (DME) providers to bill Medicare and private insurers for all DeltaWave configurations.

The PDAC decision completes the final regulatory step required for REMSleep’s full market rollout. Combined with the company’s recently expanded FDA 510(k) clearance, the approval positions DeltaWave for nationwide distribution in home care, institutional, and sleep laboratory settings.

Full Reimbursement Unlocks Commercial Scale

With reimbursement codes now in place, DME and home medical equipment providers can offer the DeltaWave system without billing limitations, a critical factor for large-scale adoption in sleep therapy.

“This milestone gives our partners everything they need to move forward—expanded FDA clearance, complete HCPCS coding, and product availability,” said Thomas Wood, founder and CEO of REMSleep. “We are now ready to fully launch DeltaWave nationwide and meet a wide range of patient and provider needs.”

Product Expansion Driven by Provider Feedback

REMSleep’s expanded DeltaWave portfolio reflects feedback gathered during a controlled soft launch in the fourth quarter of 2025. Early users, including DME providers and sleep labs, requested greater flexibility in system configurations and sizing options to better serve diverse patient populations.

“Some providers want full systems, while others prefer individual components customized for their patients,” said Jeff Marshall, REMSleep’s operations manager. “Sleep labs also asked for pillow-only options for diagnostic titration. That feedback directly shaped our final lineup.”

The updated portfolio allows providers to select complete systems or individual components, supporting both therapy initiation and diagnostic workflows.

Key Regulatory and Operational Milestones

Over the past two months, REMSleep has moved rapidly from limited launch to full commercial readiness. Notable developments include:

• January 7, 2026: FDA expands 510(k) clearance to cover additional patient groups and care environments
• January 21, 2026: PDAC approves HCPCS coding for all DeltaWave configurations
• December 2025: Completion of ERP infrastructure, sales force training, and early market validation with repeat orders and no product returns

According to the company, the transition marks a shift from pilot deployment to national distribution readiness.

Multi-Channel Market Strategy

With regulatory and reimbursement barriers removed, REMSleep is activating a three-pronged go-to-market strategy:

• DME and HME Providers: Targeting the estimated 20–30% of CPAP users who struggle with initial mask adherence, positioning DeltaWave as a “rescue mask” alternative
• Sleep Laboratories: Supplying DeltaWave for diagnostic titration, allowing patients to continue with the same mask through insurance-covered therapy
• Institutional and Acute Care: Expanding into hospitals and long-term care facilities for BiPAP and non-invasive ventilation support

“With approvals secured, we’re positioned to execute across all major channels,” Marshall said. “This is the point where planning turns into scale.”

About REMSleep Holdings

REMSleep Holdings, Inc. is a medical device company focused on improving outcomes for patients using positive airway pressure therapy. Its DeltaWave™ nasal pillow system is FDA-cleared for CPAP, BiPAP, and other non-invasive ventilation devices in both home and institutional settings. All DeltaWave products are eligible for Medicare and private insurance reimbursement following PDAC approval.

More information is available at remsleep.com.

Forward-Looking Statement

This article contains forward-looking statements subject to risks and uncertainties, including market adoption, reimbursement practices, competitive conditions, and execution of commercial strategy. Actual results may differ materially from expectations. REMSleep assumes no obligation to update these statements.

Distributed by Pinion Newswire for REMSleep Holdings, Inc.

Via Health and Fitness PH