BLACKSHEAR, Georgia—REMSleep Holdings, Inc., developer of the FDA-cleared DeltaWave nasal pillow system, announced the full commercial launch of the DeltaWave product portfolio across all United States distribution channels, including durable medical equipment (DME) companies and institutional sales.
With expanded FDA 510(k) clearance secured on Jan. 15 and Medicare PDAC coding approved for every product configuration on Jan. 21, the company passed the final regulatory prerequisites for nationwide distribution.
“After years of funding this product personally through FDA, patents, clinical testing and every operational hurdle you can imagine—it’s good to say we’re launching finally," said Thomas Wood, found and CEO of REMSleep. "Not 'preparing to launch,' not 'targeting a launch' - launching. The product works. The market needs it. The infrastructure is ready. Now we sell.”
What’s in the Portfolio
The DeltaWave Nasal Pillow System is built around a patented direct airflow technology—a design that reduces the pressure and airflow sensation patients feel at the nasal interface.
“DeltaWave was designed from day one to give patients a more comfortable breathing experience—so they stay on therapy and actually benefit from it," Wood said. "That design goal hasn’t changed. What’s changed is that we now have everything in place to put it in their hands at scale.”
The full commercial portfolio includes:
- Starter Kit: includes all three nasal pillow sizes in a single package, simplifying initial patient setup and fitting
- Single Pillow Systems: ideal for resupply
- Nasal Interface (without headgear): an additional resupply configuration
- Full Accessories Suite: complete range of replacement components
The PDAC coding approvals cover every one of these configurations for Medicare and private payer billing. DME providers now have the codes, the inventory access and the clinical rationale to bring DeltaWave into their product mix.
What This Means for the Market
CPAP compliance is a persistent problem in sleep medicine. Somewhere between 30 and 50 percent of patients prescribed therapy abandon it within the first year, and mask discomfort is consistently cited as a top reason. DME providers deal with this daily - patients calling to return masks, asking for alternatives, or simply disappearing from follow-up.
REMSleep said DeltaWave’s positioning as a rescue mask alternative gives providers a clinically differentiated option when their standard formulary isn’t working. The expanded clearance also opens institutional channels—hospitals, long-term care facilities, rehabilitation centers and sleep labs—that weren’t accessible under the original 510(k) language. Those channels tend to introduce the solution to patients at the beginning of therapy. Once patients become comfortable with the mask, they can continue to reorder, providing downstream revenue opportunities for DME partners, REMSleep said.
Ordering & Availability
The DeltaWave Nasal Pillow System is available now through REMSleep’s direct sales channels. DME providers, physicians and patients can reach the sales team at sales@remsleep.com or visit remsleep.com for product specifications, pricing and ordering information.
REMSleep said it will continue providing operational updates regularly as commercialization develops through quarter 1 and into quarter 2 2026.