SleepMed of South Carolina is One of the First Medical Centers to Participate in a Clinical Study that Evaluates an Implantable Device to Treat Obstructive Sleep Apnea

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The purpose of the Apnex Clinical Study is to determine whether the Apnex HGNS System is a safe and effective treatment for OSA in patients who have not received lasting benefit from CPAP or other OSA treatments. The study is being performed by sleep specialists at clinical study centers throughout the U.S., Australia and Europe.

This study will help us further understand what role this device could have in treating the millions of people who suffer from OSA

SLEEPMED INC. has received approval to begin a clinical study to evaluate the safety and effectiveness of the Apnex® Hypoglossal Nerve Stimulation (HGNS®) System to treat obstructive sleep apnea (OSA), becoming one of the first medical centers in the country to participate in this study.

“Many people who suffer from OSA are unable to tolerate existing therapies such as continuous positive airway pressure (CPAP). The HGNS System provides a new approach to the treatment of OSA. This study will help us further understand what role this device could have in treating the millions of people who suffer from OSA,” said the study’s co-principal investigator. We are excited to be part of this important study”, explained DR. RICHARD K. BOGAN, CHAIRMAN AND CHIEF MEDICAL OFFICER, SLEEPMED INC., and lead trial investigator at SLEEPMED OF SOUTH CAROLINA.

ABOUT OBSTRUCTIVE SLEEP APNEA
According to the World Health Organization, approximately 100 million people worldwide have OSA. In the United States, symptomatic OSA affects 1 in 4 men and 1 in 9 women. It most often occurs when the airway muscles fail to keep the airway open during sleep. Untreated OSA increases the risk of death; as well as stroke, high blood pressure, coronary artery disease, heart failure and diabetes. It causes fragmented sleep which leads to excessive daytime sleepiness, resulting in an increased risk of accidents and lost productivity. Current OSA treatments are not always successful or well tolerated.

ABOUT THE APNEX HGNS SYSTEM
    The Apnex HGNS System is an implanted medical device that activates muscles of the upper airway to ensure that the airway remains open during sleep. During sleep the system monitors the patient’s breathing and delivers mild stimulation to the hypoglossal nerve, the nerve that controls the tongue. As the nerve is stimulated, the tongue gently moves forward to keep the airway open. The stimulation is timed to a patient’s own breathing pattern. The device automatically turns on when the patient is sleeping, and turns off when the patient is awake.

ABOUT THE APNEX CLINICAL STUDY
    The purpose of the Apnex Clinical Study is to determine whether the Apnex HGNS System is a safe and effective treatment for OSA in patients who have not received lasting benefit from CPAP or other OSA treatments. The study is being performed by sleep specialists at clinical study centers throughout the U.S., Australia and Europe.

The Apnex Clinical Study is now enrolling patients. People who are interested in learning if they might qualify for the study can call 1-888-975-3370 or go to http://www.SleepApneaTrial.com.

ABOUT SLEEPMED OF SOUTH CAROLINA
For over 20 years SleepMed has been the only practice in South Carolina devoted entirely to the diagnosis and treatment of all types of sleep disorders.
Based in Columbia, SC, SleepMed inc. is the nation's largest provider of sleep and EEG diagnostic services and a major provider of therapy devices for patients all over the United States. Each of our centers is supported by highly-qualified Sleep Technologists who have an extensive experience in performing various sleep tests. Our centers use state-of-the-art technology, allowing us to monitor brain waves, breathing patterns, muscle activities, heart rate, eye movements, snoring activity, and blood oxygen level during sleep to ensure an accurate diagnosis.

ABOUT RICHARD K. BOGAN MD., FCCP, DABSM
Richard K. Bogan, MD, FCCP, is Associate Clinical Professor at the University of South Carolina School of Medicine and the Chairman and Chief Medical Officer of SleepMed Inc., both in Columbia, South Carolina. He is one of the founders of SleepMed, the largest sleep diagnostic company in the U.S.
Dr. Bogan received his medical degree from the Medical University of South Carolina in Charleston, South Carolina. He completed his Internal Medicine residency at the University of Alabama Hospitals and Clinics and his Pulmonary, Critical Care fellowship at the University of Alabama School of Medicine, both in Birmingham, Alabama.
Dr. Bogan is board certified in sleep medicine, pulmonary medicine and internal medicine with previous certification in critical care. He has served as the medical director for several hospital departments and serves on various business, community, and civic boards. He has dedicated the majority of his medical career to creating standards of excellence in sleep disease management. In addition to operating a Columbia-based, 9-bed, accredited sleep center that serves as their flagship operation and training site, he has been involved in numerous clinical research trials and has published numerous articles in sleep medicine. He has been a consultant to the pharmaceutical and device industry and has lectured in local, regional and national meetings.

Caution: The Apnex HGNS System is an investigational device and is limited by Federal (or United States) law to investigational use only.

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Patric A. Mercer, Clinical Research Manager

Margaret McDonald
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