New York, NY (September 29, 2011) – Clinilabs, a full-service contract research organization that provides early-phase and specialty clinical drug development services to industry, announced today that it 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,” says Dr. Gary Zammit, President & CEO, Clinilabs Inc. “We are excited to be part of this important study.”
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 www.SleepApneaTrial.com.
About Clinilabs Inc.
Clinilabs is a full-service contract research organization (CRO) that provides early-phase and specialty clinical drug development services to industry. One of the Company’s primary specialties is the development of therapeutic drugs and devices for sleep disorders. Clinilabs is recognized globally as a leading CRO in the field of sleep medicine, and has made important contributions to eleven successful new drug applications (NDAs) since 2001. For more information, please visit www.clinilabs.com.
For more information or to schedule an interview, please contact Hannah D’Aoust at 646.215.6480 or e-mail hdaoust@clinilabs.com
