Apnex Medical

About Apnex Medical, Inc. and the 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 HGNS System is an implantable therapy that is intended to work by ac... tivating the muscles in the upper airway to ensure that the airway remains open during sleep. During sleep, the system detects the patient's breathing and delivers mild stimulation to the hypoglossal nerve, the nerve that controls the muscles that keep the airway open. The stimulation is timed to a patient's own breathing pattern. The HGNS System is programmed to work only when the patient is asleep, or it can be turned on and off as needed through a handheld controller. About OSA According to the World Health Organization approximately 100 million people worldwide have OSA. It occurs because the airway muscles fail to keep the airway open during sleep, despite efforts to breathe. This deprives OSA sufferers of deep restful sleep. In addition to excessive daytime drowsiness and fatigue, OSA sufferers are at an increased risk for a variety of health conditions, including high blood pressure, coronary artery disease, diabetes and stroke. Untreated OSA is also associated with an increased risk of death. Current OSA treatments are not always successful or well tolerated. The Apnex device is designed to provide an alternative treatment for OSA that addresses these problems. About Apnex Clinical Study Apnex Medical received investigational device exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) to conduct a clinical study to evaluate the safety and effectiveness of its HGNS System in people who suffer OSA. Data from this clinical study is intended to support the Pre-Market Approval (PMA) application for the HGNS System to the FDA. The Apnex Clinical Study is a prospective, randomized, multi-center clinical trial. It is being conducted in leading ...Read More