Friday, February 3, 2012

PRESS RELEASE

FOR IMMEDIATE RELEASE


PMG RESEARCH OF WILMINGTON AND PMG RESEARCH OF WINSTON-SALEM: THE FIRST MEDICAL CENTERS IN NORTH CAROLINA TO IMPLANT INVESTIGATIONAL DEVICE TO TREAT OBSTRUCTIVE SLEEP APNEA

Winston-Salem, NC, Friday, February 3, 2012 – Two sites in the PMG Research network, PMG Research of Wilmington and PMG Research of Winston-Salem, implanted the Apnex® Hypoglossal Nerve Stimulation (HGNS®) System in a patient to treat obstructive sleep apnea (OSA), becoming the first medical centers in North Carolina to perform this procedure. The patients are participating in a FDA-approved clinical study. The study is sponsored by Apnex Medical, Inc.

“The Apnex HGNS System is anticipated to significantly reduce the number of times a person’s breathing is interrupted each night, in people that suffer from OSA. This new treatment offers hope to people who have not been successfully treated with continuous positive airway pressure (CPAP) devices" says Douglas Lee, MD, from Wilmington Health and lead clinical trial investigator for PMG Research of Wilmington. "We are excited to be part of this important study”, explained Jason Thomason, MD, from Salem Chest Specialists and lead clinical trial investigator at PMG Research of Winston-Salem.

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. and Australia.

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/.

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


ABOUT PMG RESEARCH

PMG Research, Inc. is an Integrated Site Network based in Winston-Salem, NC. The staff and physicians at PMG Research have contributed to the development of numerous medications, medical devices and vaccines. PMG’s mission is to provide unparalleled service to their clinical trial participants and pharmaceutical sponsors. Visit PMG Research at http://www.pmg-research.com/.

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