Magnetic Apnea Prevention(MAGNAP) Device to Treat Obstructive Sleep Apnea:First-In-Human Study of Feasibility and Safety

Magnap is a magnet-activated treatment for obstructive sleep apnea (OSA) designed to be less
invasive than reconstructive surgery, more tolerable than positive airway pressure, and more
effective than non-invasive therapies for OSA. The Magnap device consists of a
neodymium-iron-boron rare earth magnet with a ferromagnetic directional back-plate encased in
titanium. The device will be implanted surgically on the hyoid bone. Following surgery, the
patient is fitted with a custom, removable external neck accessory containing a second
magnet, which is worn during sleep and prevents airway collapse by attracting the internal
hyoid magnet with sufficient force to keep the airway open .

Inclusion Criteria:

- Patient is between 21 and ≤70 years of age

- Subject has moderate to severe obstructive sleep apnea (defined as apnea-hypopnea
index of 15-50 events/hour on baseline/screening polysomnogram)

- Subject is intolerant of positive airway pressure therapy (defined as <2 hours of
sleep time with use per night for at least 5 nights per week as measured objectively
by evaluation of continuous positive airway pressure (CPAP) machine memory chip and
interpreted by the study sleep medicine specialist)

- Subject signs and dates a written informed consent form and indicates understanding of
the study procedures and risks

Exclusion Criteria:

- Any evidence that apnea is not caused by base of tongue (i.e., central apnea,
neurologic disorder, retropalatal collapse, nasal obstruction)

- Any condition likely requiring MRI or has a metal implant

- Any factor that, in the surgeon's judgment, would pose a risk to surgery or placement
of a long-term implanted device

- Any factor that, in the surgeon's judgment, would make the subject unlikely to respond
to Magnap treatment

- Congenital anomalies of the larynx, pharynx, or trachea or any other anatomical
abnormality of the head, neck, or chest that would be a contraindication to placement
of the Magnap device and usage of the external device

- There are no exclusion criteria based on gender, race or ethnicity