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Inspire’s Medical’s STAR Clinical Trial Results Published in The New England Journal of Medicine

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Minneapolis, MN – January 8, 2014 – Inspire Medical Systems, Inc., developer of the novel Inspire

Upper Airway Stimulation (UAS) therapy for treating obstructive sleep apnea (OSA), announced today
that results from its STAR (Stimulation Therapy for Apnea Reduction) pivotal clinical trial have been
published in the January 9 issue of the New England Journal of Medicine.

The STAR trial was a multi-center clinical study designed to evaluate the safety and effectiveness of
Inspire therapy in patients with moderate to severe OSA who were intolerant to Continuous Positive
Airway Pressure (CPAP). The STAR trial was conducted at twenty two medical centers across the United
States and Europe.

In the STAR trial, patients implanted with Inspire therapy experienced a reduction in apnea events and
improvements along several indices designed to measure quality of life. Endpoint results reported in
the publication include:

• 68% median reduction in apnea hypopnea index (AHI)
• 70% median reduction in oxygen desaturation index (ODI)

Inspire Medical Systems is in the process of seeking approval from the FDA for use of Inspire therapy for
patients with moderate to severe OSA, who are intolerant to CPAP.

About Obstructive Sleep Apnea (OSA)
More than 18 million Americans have sleep apnea which is characterized by repeated episodes of upper
airway narrowing and collapse during sleep. Patients with OSA stop breathing frequently during their
sleep (apnea), often for a minute or longer. Fragmented sleep with recurrent awakening, called
arousals, leads to daytime sleepiness and fatigue. Depending on the degree of severity, OSA can be a
potentially life-threatening condition. Recent research suggests that a person with undiagnosed sleep
apnea or a person who is noncompliant to treatment of their sleep apnea is at increased risk for heart
attack, stroke, weight gain, high blood pressure and heart failure.

About Inspire® Upper Airway Stimulation (UAS) therapy

Inspire therapy is a fully implanted system that is designed to sense breathing patterns and deliver mild
stimulation to a patient’s airway muscles to keep the airway open during sleep. Inspire therapy uses
proprietary technology that delivers stimulation therapy based on a patient’s unique breathing patterns.

About Inspire Medical Systems
Inspire Medical Systems is based in Maple Grove, Minnesota. Inspire was formed in 2007 when the
technology and a significant intellectual property portfolio was spun-out of Medtronic (NYSE: MDT).
Visit Inspire Medical Systems on the web at


The Inspire system is an investigational device and is not currently for sale in the U.S.

Media contacts:
Helen Shik or Sherry Feldberg
MSL Boston
[email protected]
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