SAN FRANCISCO—SleepRes, Inc., a sleep technology company focused on reimagining therapy for sleep breathing disorders, announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the Kricket PAP device, powered by Kairos Positive Airway Pressure (KPAP) for the treatment of obstructive sleep apnea (OSA) in patients weighing more than 66 pounds. The SleepRes PAP system is intended for home, hospital/institutional and sleep center settings.
The Kricket PAP device features proprietary KPAP technology, designed to dynamically adapt pressure delivery throughout the breathing cycle, rather than maintaining a constant, fixed pressure like traditional CPAP devices. By synchronizing therapy with a patient’s natural respiration and airway dynamics, SleepRes said KPAP aims to reduce unnecessary pressure, which may minimize discomfort, alleviate common side effects and improve tolerance during sleep. The device includes the KPAP algorithm, as well as traditional CPAP and automatic PAP therapy modes.
“This milestone marks an important moment for the field of sleep medicine,” said David White, chief medical officer of SleepRes. “Kricket opens the door to a new category of positive airway pressure therapy that prioritizes comfort, the patient's ability to adapt and real-world use, while still delivering the therapy patients need. That balance is critical if we want to meaningfully improve long-term outcomes for people living with obstructive sleep apnea.”
Obstructive sleep apnea affects up to 60 million adults in the United States and is associated with serious health consequences such as cardiovascular disease, diabetes, stroke, depression and increased risk of motor vehicle accidents. CPAP therapy has been the standard of care for decades, but long-term adherence remains low due to pressure and mask-related issues. Consequently, untreated OSA is pervasive. KPAP technology was designed to address the discomfort associated with CPAP therapy with an innovative approach to air pressure delivery that emulates human breathing for a more natural feel.
“Today completes a 4 [plus] year pursuit to provide my own patients with technology designed to emulate natural breathing and address the discomfort and pressure intolerance common with traditional CPAP,” said William H. Noah, founder of SleepRes and inventor of KPAP. “Today also begins a new era of PAP therapy and a new hope not only for my patients but patients across the U.S., especially those beginning PAP or those who have previously tried and failed.”
SleepRes plans to commercially launch Kricket in the first half of 2026. The company is actively preparing to scale manufacturing, developing clinical partnerships, and providing education on KPAP ahead of launch.
“FDA clearance of Kricket marks a pivotal moment for patient care in sleep medicine,” said John Lipman, CEO of SleepRes. “It validates the innovation behind our technology and moves us another step closer to our mission of improving outcomes for people living with sleep apnea.”