Neurostimulation Established as a Treatment Option for Sleep Apnea Patients Who Do Not Tolerate CPAP

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New Results of Landmark Long-Term Sleep Apnea Study Published:
Inspire Upper Airway Stimulation Therapy Shows Significant and Sustained
Reductions in Sleep Apnea Severity, Improvements in Quality of Life and High
Adherence Rates at Three Years

MINNEAPOLIS (November 19, 2015) — Inspire Medical Systems, Inc., announced
today the results of a landmark long-term clinical study for its Inspire Upper Airway
Stimulation (UAS) System, the first FDA-approved implantable neurostimulation
treatment for people diagnosed with Obstructive Sleep Apnea (OSA). OSA affects
more than 18 million Americans and can have devastating effects on heart and brain
health, impair quality of life and increase accident risk.

Inspire therapy is for some people diagnosed with moderate to severe OSA who are
unable to tolerate or get relief from Continuous Positive Airway Pressure (CPAP). In
contrast to CPAP, Inspire therapy works inside the body and with a patient’s natural
breathing process. Controlled by the patient sleep remote, the system includes a
breathing sensor and a stimulation lead powered by a small battery. During sleep,
the system senses breathing patterns and delivers mild stimulation to the tongue
and other soft tissues of the throat to keep the airway open. Inspire therapy is
currently available at more than 60 leading medical centers across the United States
and Europe.

The Stimulation Therapy for Apnea Reduction (STAR) trial was conducted at 22
leading sleep medicine centers across the United States and Europe. One-year STAR
trial outcome measures, published in the January 9, 2014 edition of the New England
Journal of Medicine, showed that sleep apnea patients receiving Inspire therapy
experienced significant reductions in sleep apnea events and significant
improvements in quality of life measures. The new long-term study outcomes
showed that the improvements observed at one-year were sustained at the three-
year follow up mark. The outcomes include:

  • A 78 percent reduction in apnea-hypopnea index (AHI) from baseline
  • An 80 percent reduction in oxygen desaturation events from baseline
  • 80 percent of bed partners reported soft or no snoring as compared to 17
    percent of bed partners at baseline
  • Quality of life measures, including daytime sleepiness and functioning,
    showed clinically meaningful improvements and a return to normal levels
    over baseline.

The results were published this week in the online issue of Otolaryngology – Head
and Neck Surgery, the official peer-reviewed publication of the American Academy
of Otolaryngology – Head and Neck Surgery Foundation.

The biggest challenge for OSA patients is that many are unable to tolerate or get
relief from CPAP. Published studies show that CPAP adherence rates are less than
50 percent. In contrast, the new data from the STAR Trial demonstrate that more
than 80 percent of the patients with Inspire therapy report nightly use after three
years of being prescribed the therapy.

The data was recently presented at the annual American Academy of
Otolaryngology – Head and Neck Surgery Foundation meeting in Dallas by
B. Tucker Woodson, MD, Chief, Division of Sleep Medicine at Froedtert Hospital and
the Medical College of Wisconsin. Dr. Woodson is the lead author of the 36-month
manuscript. “The data confirms that Inspire Upper Airway Stimulation therapy is
safe and effective and that the results are consistent over the long term,” said Dr.
Woodson. “We also observed high therapy adherence rates throughout the three-
year STAR trial follow-up period. It is exciting to have an effective treatment to help
those sleep apnea patients who are not able to tolerate or achieve consistent benefit
from CPAP.”

“The three-year study outcomes are significant as they demonstrate that
improvements in both objective respiratory and subjective quality of life measures
are maintained,” says Tim Herbert, Chief Executive Officer of Inspire Medical
Systems. “We thank and congratulate both the STAR trial investigator group and the
author team for completing the long-term follow up and publishing these important
outcomes.”

About Inspire Therapy
Untreated Obstructive Sleep Apnea (OSA) can have devastating effects on heart and
brain health, impair quality of life, and increase accident risk. Inspire Upper Airway
Stimulation (UAS) therapy is an FDA-approved treatment for some people with
moderate to severe OSA who are unable to tolerate or get relief from CPAP. In
contrast to CPAP, Inspire therapy is implanted inside the body and works with a
patient’s natural breathing process. Controlled by the patient sleep remote, the
system includes a breathing sensor and a stimulation lead powered by a small
battery. During sleep, the system senses breathing patterns and delivers mild
stimulation to the tongue and other soft tissues of the throat to keep the airway
open. Inspire therapy is currently available at more than 60 leading medical centers
across the United States and Europe.

About Inspire Medical Systems, Inc.
Inspire Medical Systems, Inc., based in Minneapolis, Minn., was incorporated in
2007 with the sole purpose of developing a safe, effective and well-accepted therapy
to help those OSA patients who are unable to tolerate or get relief from CPAP.
Inspire therapy is the world’s first implantable FDA-approved neurostimulation
system for the treatment of OSA. The Company is privately held and investors
include Aperture Venture Partners, GDN Holdings, Johnson & Johnson, Kleiner
Perkins Caufield & Byers, Medtronic, OrbiMed Advisors, Synergy Life Science
Partners, TGap Ventures and US Venture Partners.
For more information, visit www.InspireSleep.com.