The company rolls out its FDA-cleared nasal pillow system nationwide as Jeffrey Marshall takes over as CEO following the death of founder Thomas Wood.
Key takeaways:
- REMSleep launched its DeltaWave nasal pillow system across US distribution channels after securing expanded FDA 510(k) clearance and Medicare PDAC coding.
- Founder and former CEO Thomas Wood passed away on Feb 26, leaving a legacy of 26 patents in CPAP interface components.
- Jeffrey Marshall has been appointed CEO, and Anita Michaels has been elected chairman of the board to lead the company’s commercialization efforts.
REMSleep Holdings Inc has announced the full commercial launch of its DeltaWave nasal pillow system across all US distribution channels, coinciding with a planned leadership transition following the passing of founder Thomas Wood.
Wood, who served as chairman of the board and CEO, passed away on Feb 26. According to the company, his design journey began in 1981, eventually securing 26 patents for various components of CPAP interfaces, culminating in the development of the DeltaWave system.
Under Wood’s leadership, REMSleep achieved several regulatory and commercial milestones:
- FDA 510(k) clearance for the DeltaWave nasal pillow system
- PDAC coding approval enabling Medicare reimbursement
- Buildout of manufacturing and distribution infrastructure
- Positioning for commercial launch and market entry
“Tom was more than a founder; he was a visionary and patient advocate who believed that sleep apnea patients deserved better options,” says Anita Michaels, chairman of the board, in a release. “He spent years raising funding to build DeltaWave, complete the FDA clearance process, and built REMSleep from the ground up. His legacy lives on in the DeltaWave technology and in our commitment to bringing this innovation to the patients who need it.”
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
“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,” Wood said in a release shortly before his death.
Prior to his passing, Wood worked with Michaels, who serves as chief operating officer, and incoming CEO Jeffrey Marshall to prepare a succession plan. Following his death, the board of directors was reconstituted to ensure continuity:
- Anita Michaels has been elected chairman of the board. As Wood’s sister, chief operating officer, and the company’s majority shareholder, she brings a deep understanding of REMSleep’s history and technology.
- Jeffrey Marshall has been appointed chief executive officer and director. Marshall brings industry experience in sales, marketing, business development, and commercial strategy.
- Alexander Johnson has been appointed as director, bringing expertise in corporate restructuring, capital markets, and public company compliance.
The leadership change aligns with the nationwide rollout of the DeltaWave product portfolio to durable medical equipment (DME) companies and institutional sales channels, including hospitals, long-term care facilities, rehabilitation centers, and sleep labs.
The DeltaWave system features patented direct airflow technology designed to reduce the pressure and airflow sensation patients feel at the nasal interface. With Medicare PDAC coding approved for every product configuration, DME providers can now bill Medicare and private payors.
“This transition is a pivotal moment for REMSleep,” says Marshall in a release. “Tom built the foundation achieving FDA clearance, Medicare approval, and a differentiated product. Now it’s our job to execute the commercial opportunity he created. The DeltaWave technology is ready for market, our infrastructure is in place, and we’re focused on revenue generation and sustainable growth.”
