SleepRes announced that it received FDA 510(k) clearance for its Kricket PAP device for treating obstructive sleep apnea (OSA).
Kricket PAP is powered by the company’s Kairos Positive Airway Pressure (KPAP) technology. San Francisco-based SleepRes says the technology offers an alternative to traditional continuous positive airway pressure (CPAP) devices that have long been the standard of care in treating OSA.
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Clearance covers patients weighing more than 66 lbs, with uses in the home, hospital and in sleep center settings. Market entry in the U.S. could pit SleepRes against ResMed, a leader in CPAP, as well as Inspire Medical and Nyxoah, which both have neuromodulation systems that treat OSA. LivaNova is also looking to crack that market with its own nerve stimulation system.
SleepRes says it designed its technology to dynamically adapt pressure delivery throughout the breathing cycle. This differs from CPAP, which maintains a constant, fixed pressure, the company says. By synchronizing therapy with natural respiration and airway dynamics, KPAP could reduce unnecessary pressure. This may minimize discomfort, alleviate common side effects and improve tolerance during sleep.
KPAP features the company’s KPAP algorithm, but also includes CPAP and automatic PAP therapy modes.
SleepRes plans to commercially launch Kricket in the first half of 2026. It has plans underway to scale manufacturing, develop clinical partnerships and provide education ahead of the rollout.
Dr. David White, Chief Medical Officer of SleepRes, said:
“This milestone marks an important moment for the field of sleep medicine. 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.”
Dr. William H. Noah, Founder of SleepRes and inventor of KPAP, said:
“Today completes a 4+ 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. 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.”
John Lipman, SleepRes CEO, said:
“FDA clearance of Kricket marks a pivotal moment for patient care in sleep medicine. 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.”
