FAST as a Treatment for Obstructive Sleep Apnea

Obstructive sleep apnea (OSA) has become a major health problem in the United States. With
prevalence in middle-aged adults of 2-4% of the population, untreated OSA has been
implicated in increased risk for cardiovascular disease, including hypertension and heart
failure.

The first and most common treatment for OSA is continuous positive airway pressure (CPAP)
treatment, utilized by an estimated 3 million Americans. CPAP is effective in reducing
apnea-hypopnea index (AHI) is used properly. However, the nasal mask required for CPAP
during sleep leads to poor acceptance and compliance rates. Published studies on CPAP have
shown that only 58-8-% of patient accept CPAP therapy and further 65-90% of these patients
exhibit long-term compliance with CPAP.

It is widely accepted that the region behind the tongue is a major site of collapse during
obstructive sleep apnea. In fact there are many surgical procedures performed currently to
address tongue based collapse. These include RF ablation of the tongue base, genioglossus
advancement, hyoid suspension, maxillomandibular advancement, and tongue base suspension.

The current study is designed to evaluate the feasibility of tongue stabilization, and
assess safety and treatment of the tongue stabilization.

Inclusion Criteria:

- Documented diagnosis of moderate obstructive sleep apnea (AHI 5-30/hour) measured
within 12 months prior to the planned procedure

- Age >/= 20 and >/= 65

- Body Mass Index ,/= 32 (kg/m2)

- Patient offered CPAP and has refused of failed to continue CPAP treatment or is not
compliant with CPAP

- Signed informed consent to participate in this study

Exclusion Criteria:

- Prior OSA surgery

- Active systemic infection

- Allergy to any medication used during implantation

- Previous history of neck or upper respiratory tract

- Significant dysphagia or speech disorder

Anatomical

- Identified obvious palatal stenosis

- Enlarged tonsils (3+)

- Anatomy unable to accommodate the implant

Other

- Other medical, social, or psychological problems that , in the opinion of the
investigator, precludes the patient from receiving this treatment and the procedures
and evaluations pre- and post-treatment

- Enrollment in another pharmacological or medical device study that may effect or bias
the results of this clinical study

- Unable and/or not willing to comply with treatment follow-up requirements

- Pregnancy (Female subjects of childbearing potential must have a negative pregnancy
test prior to enrollment