REMSleep plans ‘big push’ for DeltaWave in competitive CPAP mask market

BLACKSHEAR, Ga. – REMSleep says the final pieces of its commercial strategy for the DeltaWave nasal pillow system are falling into place as the company prepares for a broader market push. 

FDA clearance expands DeltaWave's use case 

Most recently, REMSleep received expanded 510(k) clearance from the U.S. Food and Drug Administration (FDA) for DeltaWave to be used across care settings (home, hospitals, institutions and sleep labs) and across pressure modalities – not just CPAP. 

“This is the fun part,” said Jeff Marshall, who has been helping Founder and CEO Thomas Wood get the company off the ground. “They spent years on design. Last year, we spent time building the company. Now, we’re sitting at the point where we have approval, we have inventory, and we’re ready to have our big push.” 

Soft launch feedback prompts request for expanded clearance 

In July, REMSleep announced that industry veteran John Stelzner had joined the company to develop a sales channel for the DeltaWave in the HME sector and in the fourth quarter it soft-launched the product. Early feedback prompted REMSleep to seek its expanded FDA clearance, Marshall says. 

“We got some product in the market and received feedback that they liked the masks, but the original 510(k) clearance was too restrictive,” he said. 

A crowded CPAP mask market — but room for innovation 

While the HME market has plenty of mask options—an HME Newspoll recently found only 45% of providers plan to add new CPAP masks this year, compared to 72% planning to add new CPAP devices—Marshall says DeltaWave stands apart. 

Rather than producing another “me-too” product, Wood focused on making breathing easier on both inhalation and exhalation. The result, Marshall says, is a mask designed for lower airflow and pressure, improving comfort and patient compliance. 

“The whole design process was, ‘Let’s fix these problems and create an alternative for providers and patients,’” he said. 

Wood, a respiratory therapist, is also the inventor behind Nasal Aire, Nasal Aire II and Petite Nasal Aire. 

Mask fit challenges remain a costly issue for providers 

Mask fit continues to be one of the biggest challenges for sleep providers. Marshall, who has worked in both the manufacturer and provider sides of the industry, estimates the U.S. mask refit rate sits at around 20%. 

“If you’re setting up 100 masks, 20 will need refit in 30 days,” he said. “This is why we are positioning DeltaWave as a rescue mask to help providers capture these failing patients.” 

Next steps: Reimbursement confirmation and clinical trials 

In the coming weeks, REMSleep plans to activate a full commercial launch and continue to build its leadership team. The company also expects to launch clinical studies in the second quarter. 

“We have the trials for the FDA process, but not use and preference trials,” he said. “We’ll be doing that to build up our claims list.”