Supplemental Clearance Opens Institutional Markets and Expands Patient Population Beyond Traditional CPAP Therapy
BLACKSHEAR, GA - January 15, 2026 (NEWMEDIAWIRE) - REMSleep Holdings, Inc. (OTCQB: RMSL), developer of the FDA-cleared DeltaWave™ nasal pillow system, today announced receipt of expanded 510(k) clearance (K253939) from the U.S. Food and Drug Administration. The approval, granted January 15, 2026, significantly broadens DeltaWave's indicated use beyond home-based CPAP therapy to include institutional settings and a wider range of patient populations.
The expanded clearance represents a direct response to feedback from early adopters during REMSleep's Q4 2025 soft launch. Healthcare providers reported that patients in different care settings - hospitals, long-term care facilities, rehabilitation centers, and sleep labs - could benefit from DeltaWave but were restricted by the original clearance language.
"Our customers told us they were seeing patients who needed what DeltaWave offers but couldn't access it because of how narrowly we'd written the original 510(k)," said Thomas Wood, CEO and founder of REMSleep. "Sleep technicians, pulmonologists, and respiratory therapists work with these patients every day. When they tell us there's a clinical need, we listen."
What Changed:
The original 510(k) clearance, granted in 2024, limited DeltaWave to home use with continuous positive airway pressure (CPAP) devices for obstructive sleep apnea treatment. The supplemental clearance expands the indicated use in two critical ways:
Settings: DeltaWave is now cleared for use in hospitals, long-term care facilities, rehabilitation centers, sleep laboratories, and other institutional environments for single-patient use. Previously restricted to home care settings only.
Patient Populations and Device Modalities: The expanded clearance covers use with all non-invasive positive airway devices. This opens DeltaWave to patients with central sleep apnea, complex sleep apnea, congestive heart failure, neuromuscular diseases, and COPD - conditions requiring more modalities and therapy than traditional CPAP.
Why This Matters:
The expanded clearance addresses three strategic opportunities that surfaced during REMSleep's market entry:
Institutional Sales Channel: Hospitals and long-term care facilities struggle to find the right fit and function for patients so they can transition to the next care setting. DeltaWave will offer a great option for physicians and respiratory therapists to provide comfortable therapy.
Diagnostic Titration Settings: Sleep laboratories conduct overnight studies where patients are fitted with masks and pressure settings are calibrated. Lab technicians requested access to DeltaWave for patients struggling with traditional interfaces during diagnostic sessions. The expanded clearance allows DeltaWave use during titration studies, creating opportunities for patients to experience the device before going home.
Complex Patient Populations: Patients with congestive heart failure, COPD, or neuromuscular diseases often require BiPAP or ventilation modalities. These patients frequently experience mask fit challenges that can lead to therapy abandonment. DeltaWave's direct-flow technology and flexible pillow design address comfort issues particularly acute in these medically fragile populations.
Customer-Driven Development:
REMSleep submitted the supplemental 510(k) application in early December 2025 after consolidating feedback from early adoption partners. The feedback was consistent: the device was performing well clinically, but the narrow indicated use created barriers to broader adoption.
"You asked, we listened," Wood said. "That's not marketing speak. We had sleep lab directors, hospital respiratory therapists, and DME providers all telling us the same thing - patients in their care settings needed access to this device. Our job was to work through the regulatory process to make that happen."
Market Implications:
The expanded clearance positions REMSleep to execute on all three channels outlined in the company's Q1 2026 strategy announced December 30:
- DME/HME providers can now position DeltaWave as a rescue mask for patients failing traditional interfaces across all pressure modalities, not just CPAP.
- Sleep laboratories and pulmonologists can introduce patients to DeltaWave during diagnostic titration, creating brand preference before patients enter the home care channel.
- Institutional sales teams can now approach hospital respiratory departments, long-term care facilities, and rehabilitation centers with a device cleared for their patient populations and care environments.
"The timing is deliberate," Marshall said. "We spent Q4 building infrastructure - sales force, inventory systems, replacement parts. Now we have the regulatory clearance to support the full strategy. Everything's aligned."
Next Steps:
REMSleep will update marketing materials, sales training, and product labeling to reflect the expanded indicated use. The company is notifying existing partners and potential institutional customers about the expanded clearance.
The expanded 510(k) clearance is publicly available in the FDA's 510(k) Premarket Notification database under device number K253939.
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. The system is designed to address common compliance challenges through its patented direct-flow interface technology.
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, the company's ability to penetrate institutional markets, the development of distribution partnerships, 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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