The FDA has granted StimAire Breakthrough Device Designation for its injectable hypoglossal nerve stimulator and wearable, which is intended to treat adults with moderate to severe Obstructive Sleep Apnea (OSA).

The StimAire device is intended to be used by patients who have been confirmed to fail, not tolerate, or refuse OSA treatment with Positive Airway Pressure (PAP) treatments, including CPAP or bi-level positive airway pressure (BPAP) devices, and/or Mandibular Advancement Devices (MAD)/oral appliances.

Breakthrough status is reserved for technologies that demonstrate the potential to be more effective than the current standard of care in patients with serious or life-threatening conditions. The StimAire team looks forward to working with FDA as we march onward through the regulatory pathway.