9/24/2012 8:44:07 AM
ST. PAUL, Minn., Sept. 24, 2012 /PRNewswire/ -- Apnex Medical, Inc., a private medical device company, has received private financing totaling $10 million from New Enterprise Associates (NEA). The funds will be used to support the ongoing Apnex Clinical Study. The study is evaluating the safety and effectiveness of the Hypoglossal Nerve Stimulation (HGNS®) System in obstructive sleep apnea (OSA) patients.
"We are pleased to secure this financing. It enables us to continue our randomized clinical trial of the HGNS System and build evidence to support its use in appropriate patients with OSA," said Robert Atkinson, President, CEO and Founder of 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 activating 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.
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 medical centers in the United States, Europe and Australia. The trial is designed to demonstrate the safety and effectiveness of the HGNS therapy in treating patients with moderate or severe OSA who have not received lasting benefit from continuous positive airway pressure (CPAP) and other OSA treatments.
For more information on the Apnex Clinical Study, including participation requirements, visitwww.SleepApneaTrial.com or call 1-888-975-3370.
Favorable HGNS Feasibility Study Results Published
The results from the Apnex feasibility trials have been published in three peer-reviewed publications in leading medical journals. The recent findings demonstrate how the HGNS System works and that the therapy can be effective in treating moderate-to-severe OSA. Access to the publication abstracts is available from PubMed by clicking the links below.
1. Goding GS Jr, Tesfayesus W, Kezirian EJ. Hypoglossal Nerve Stimulation and Airway Changes under Fluoroscopy.Otolaryngol Head Neck Surg. 2012; 146(6):1017-1022.
2. Schwartz AR, Barnes M, Hillman D, Malhotra A, Kezirian E, Smith PL, Hoegh T, Parrish D, Eastwood PR. Acute Upper Airway Responses to Hypoglossal Nerve Stimulation during Sleep in Obstructive Sleep Apnea.Am J Respir Crit Care Med. 2012;185(4):420-426.
3. Eastwood PR, Barnes M, Walsh JH, Maddison KJ, Hee G, Schwartz AR, Smith PL, Malhotra A, McEvoy RD, Wheatley JR, O'Donoghue FJ, Rochford PD, Churchward T, Campbell MC, Palme CE, Robinson S, Goding GS, Eckert DJ, Jordan AS, Catcheside PG, Tyler L, Antic NA, Worsnop CJ, Kezirian EJ, Hillman DR. Treating obstructive sleep apnea with hypoglossal nerve stimulation.Sleep. 2011;34(11):1479-1486.
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, Apnex and HGNS are registered trademarks of Apnex Medical, Inc.
© Apnex Medical, Inc. 2012 All rights reserved.
SOURCE Apnex Medical, Inc.