ST. PAUL, Minn. and NEW ORLEANS, May 17 /PRNewswire/ -- Apnex Medical announced today that preliminary data from a first-in-man clinical study showed significant improvements in sleep for people suffering from obstructive sleep apnea (OSA). The Apnex HGNS™ System, developed by the St. Paul-based company, is a device designed to treat OSA, which is a serious life-threatening illness characterized by fragmented sleep and excessive day-time sleepiness. The HGNS System activates an upper airway muscle during sleep, which opens the airway, allowing patients to breathe and remain asleep.
"These results demonstrate the potential benefits the HGNS System could provide to patients who do not tolerate continuous positive airway pressure (CPAP) therapy," said Peter Eastwood, Ph.D., Senior Research Fellow at the West Australian Sleep Disorders Research Institute, Sir Charles Gairdner Hospital, Professor at the School of Anatomy and Human Biology, University of Western Australia, and an investigator with this study. "In most patients, the Apnex HGNS System reduced the severity of their OSA condition, allowing them to sleep better and feel better."
Three- and six-month data from the Australian first-in-man study evaluating the safety and efficacy of the HGNS System were presented today by Dr. Eastwood, as part of the session, "New Treatment Approaches for Lung Disease: Late Breaking Abstracts," at the American Thoracic Society (ATS) 2010 International Conference. The findings show the HGNS System reduced the severity of OSA by an average of over 50%, as measured by the apnea-hypopnea index (AHI). AHI measures the number of times per hour during sleep that a person either stops breathing or has restricted breathing. Patients also experienced significant improvements in symptoms, as measured by multiple quality of life surveys. Patients tolerated the treatment well, with an average of 6.5 hours of use each night. There were no device failures during the study.
"These data give us confidence that the HGNS System works, patients use it, and patients sleep better because of it," said Robert Atkinson, Apnex Medical president and chief executive officer. "They have improved oxygen levels during sleep and are waking up less, which we believe can lead to better overall health. We are learning a tremendous amount about this new therapy, which we believe will lead to even better outcomes through therapy adjustment and patient selection. We are excited about our on-going clinical trials in the United States and Australia, the results of which will support future applications for commercial approval."
About Apnex Medical and HGNS System
Apnex Medical was founded in 2006 with a mission to pioneer medical innovations to improve the health of people with sleep disordered breathing. The company has developed a proprietary medical device for the treatment of OSA.
The Apnex Hypoglossal Nerve Stimulation (HGNS) System is an implanted medical device that activates an upper airway muscle to prevent the tongue from blocking the airway during sleep. It is fully automatic and can be implanted during a simple surgical procedure. After it is implanted, the device is programmed to meet the unique needs of each patient. The device automatically turns on when the patient is sleeping and turns off when the patient is awake.
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. The Apnex HGNS System is designed to provide an alternative treatment for OSA that addresses these problems.
About US Clinical Study
The Apnex HGNS System is currently being evaluated in a clinical study in the United States. The overall purpose of the study is to demonstrate the safety and effectiveness of system in treating OSA. Additional information on the HGNS System and US clinical study is available on the Apnex Medical website at www.apnexmedical.com. There is a sign-up option for anyone interested in receiving Apnex Medical news updates or being provided more information on the clinical study.
About American Thoracic Society
The American Thoracic Society (ATS) is a non-profit, international, professional and scientific society for respiratory, critical care and sleep medicine. The ATS is committed to the prevention and treatment of respiratory disease through research, education, patient care and advocacy. The long-range goal of the ATS is to decrease morbidity and mortality from respiratory, critical care and sleep disorders and life threatening acute illnesses in people of all ages. In keeping with these goals, ATS interacts with both national and international organizations which have similar goals. For more information, visit www.thoracic.org.
CAUTION: The Apnex HGNS System is an investigational device and is limited by Federal Law to investigational use.
FOR CLINICAL TRIAL USE ONLY.
Apnex Medical and HGNS are trademarks of Apnex Medical, Inc.
© Apnex Medical, Inc. 2010. All rights reserved.
SOURCE Apnex Medical, Inc.