Stimulation Therapy for Apnea Reduction (Www.theSTARtrial.Com)

The STAR trial is a multicenter, prospective trial that includes a randomized controlled
therapy withdrawal study. The primary and secondary endpoint data were collected during an
in-laboratory sleep study 12 months after the device implant and were compared against the
baseline sleep studies. Following the 12-month visit, 46 consecutive responding subjects
were randomized 1:1 to either a therapy maintenance group (ON group) or a therapy withdrawal
group (OFF group). A subsequent sleep study of the two randomized groups was conducted and
results were compared between the two groups. In addition, quality of life questionnaires
were administered at baseline and at the 12-month visit to further assess the effectiveness
of Inspire therapy.

The STAR trial was conducted at 15 clinical sites in the United States and 7 in Europe. Of
the 126 implanted subjects in the STAR trial, 87 or 69% were implanted in the United States.
The remaining 39 subjects or 31% were implanted in Europe.

The STAR trial subjects were evaluated prior to implant to ensure the following: 1) that
their pre-implant AHI (as scored during an in-laboratory sleep study prior to implant) was
between 20 and 50 events per hour, 2) that any AHI contribution from central or mixed sleep
apnea was less than 25%, 3) that subjects did not have primarily lateral OSA (defined as
limited sleep apnea when lying on their side), and 4) that the subjects did not have a
complete concentric collapse at the level of the soft palate while observed during a
drug-induced sleep endoscopy (DISE).

After successful pre-implant screening, the subjects were implanted with the Inspire system.
The subjects were allowed to recover for 1 month following surgery, at which time a second
in-laboratory sleep study was conducted without activating the Inspire device. The results
of this 1-month sleep study were averaged with the results of the pre-implant sleep study,
and the average is defined as the subject's baseline.

The Inspire device is programmable in order to optimize a subject's response to therapy. The
initial device settings are programmed in an office setting. Additional adjustments are made
during an overnight sleep study whereby real time review of the polysomnogram (PSG) is
available to aid in device setting adjustments during the 2 and 6-month visit.

At the 12-month in-laboratory sleep study, no device adjustments were allowed as this sleep
study was the primary endpoint sleep study. Furthermore, no device adjustments were allowed
at the 13-month sleep study which was the randomized controlled therapy withdrawal sleep
studies.

Blinding was not possible during the study since the stimulation therapy evokes a
physiological response in the subjects. However, the primary endpoints were based on the
objective measures of AHI and oxygen desaturation index (ODI) which were collected during an
overnight sleep study using PSG. The sleep studies were all scored by an independent core
lab in order to minimize assessment bias. Furthermore, the sleep study results, as well as
all other clinical results, were 100% source data verified by the Inspire clinical
monitoring team.

Inclusion Criteria:

- Likely suffer moderate-to-severe OSA based on history and physical

- Have failed or have not tolerated CPAP treatment

- Willing and capable of providing informed consent

- Willing and capable to have stimulation hardware permanently implanted, and to use
the patient programmer to activate the stimulation

- Willing and capable to return for all follow-up visits and sleep studies, including
the evaluation procedures and filling out the questionnaires

Exclusion Criteria:

- Body Mass Index limits

- Surgical resection or radiation therapy for cancer or congenital malformations in the
larynx, tongue, or throat

- Significant co-morbidities making the patient unable or inappropriate to participate
in the trial