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REMSleep Holdings Announces Full Commercial Launch of DeltaWave(TM)

Nasal Pillow System All Configurations and Accessories Now Available to DME Providers, Physicians, and Patients Nationwide - The Last Piece of a Three-Year Build Has Clicked Into Place

This isn’t a soft launch or a limited rollout. It’s the real thing.

With expanded FDA 510(k) clearance secured on January 15 and Medicare PDAC coding approved for every product configuration on January 21, the final regulatory prerequisites for nationwide distribution are now in place. REMSleep is fully open for business.

How We Got Here

Shareholders who’ve followed along over the past several months know this moment didn’t happen overnight. The company has been methodically building the foundation required to support a commercial launch that could actually scale:

  • December 2025: Enterprise ERP systems activated, nationwide independent sales force deployed across 48 states, product inventory received
  • December 2025: Zero-return, repeat-order results validated from early adopting DME partners during soft launch
  • January 7, 2026: Expanded 510(k) clearance (K253939) received - DeltaWave’s indicated use broadened to BiPAP, institutional settings, hospitals, long-term care, and sleep labs
  • January 21, 2026: Full PDAC/HCPCS coding approval received for every DeltaWave configuration, enabling DME providers to bill Medicare and private insurers
  • February 2026: Full commercial launch, all channels, all configurations

That’s the arc. Infrastructure first. Clearances second. Launch third.

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. It’s a unique engineering design with real clinical impact: patients who feel less effects of pressure tend to stay on therapy longer. That’s the therapy compliance problem this product was built to solve.

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 payor 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.

DeltaWave’s positioning as a rescue mask alternative gives providers a clinically differentiated option when their standard formulary isn’t working. That’s a concrete value proposition, that has real world application.

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 begining of therapy.  Once patients become comfortable with the mask they will continue to reorder providing downstream revenue opportunities for our DME partners.

Thomas Wood, CEO and Founder

“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. Not 'preparing to launch,' not 'targeting a launch' - launching. The product works. The market needs it. The infrastructure is ready. Now we sell.”

Wood added: “DeltaWave was designed from day one to give patients a more comfortable breathing experience - so they stay on therapy and actually benefit from it. 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.”

Ordering and 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 www.remsleep.com for product specifications, pricing, and ordering information.

REMSleep will continue providing operational updates on a regular basis as commercialization develops through Q1 and into Q2 2026.

 About REMSleep Holdings, Inc.

REMSleep Holdings, Inc. (OTCQB: RMSL) is a medical device company focused on improving 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 across multiple channels and care settings, 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
www.remsleep.com
3222 HWY 84 Suite 101, Blackshear, GA 31516

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