ARCTIC 3

This is a prospective, multicenter, non-randomized single-arm safety and performance study to collect data to evaluate the safety of the Cryosa procedure to treat obstructive sleep apnea (OSA) in patients with moderate to severe OSA. The study will also evaluate the chronic performance of the Cryosa system and collect clinical measures for therapy effectiveness that will be used to demonstrate safety and effectiveness in the next clinical study.

In order to participate you must meet the following criteria:

• Are not able to use, refuse to use, or are intolerant of Positive Airway Pressure (PAP) or Mandibular Advancement Devices (MAD). If using, must be < 4 hours per night, < 5 days/week.
• Have failed, are not a candidate for, or have refused other invasive procedures such as hypoglossal nerve stimulation or pharmacotherapy for the primary treatment of OSA such as Tirzepatide.
• Have a BMI ≤ 40 kg/m2 at enrollment.
• Have an AHI ≥30 at enrollment based on in-lab polysomnography study or an AHI ≥ 15 and BMI of ≥ 30 at enrollment based on in-lab polysomnography study.

This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.