Apnex Gets FDA OK for Sleep Apnea Device Trial
St. Paul-based Apnex Medical, Inc., on Tuesday announced that it has received approval from the U.S. Food and Drug Administration (FDA) to launch a clinical study for a product designed to treat obstructive sleep apnea.
The company received investigational device exemption approval from the FDA, and its study will evaluate the safety and effectiveness of its Hypoglossal Nerve Stimulation System (HGNS).
The HGNS is an implantable therapy that is meant to keep a patient's airway open during sleep by occasionally stimulating a nerve that controls the muscles of the tongue.
Apnex said that the randomized clinical trial will be conducted in leading medical centers in the United States, Europe, and Australia. Data from the study is meant to support a pre-market approval application to the FDA.
One of the study's principal investigators, Dr. Atul Malhotra of Brigham and Women's Hospital of Boston, said in a statement that some sleep apnea patients are unable to tolerate existing therapies like continuous positive airway pressure, which keeps the airway open by delivering a constant flow of air.
Apnex was founded in 2006 to develop treatments for obstructive sleep apnea, a condition from which approximately 100 million people suffer worldwide.