Only three companies are developing implanted devices to treat obstructive sleep apnea, a condition that affects about 18 million people.
On Tuesday, Apnex Medical, one of two sleep-apnea treatment startups based in Minnesota, became the second company to get clearance from the U.S. Food and Drug Administration on a clinical trial to test its device.
The company’s CEO Chas McKhann said a total of 132 patients will be enrolled across 15 medical centers in the United States and five other centers in Europe and Australia.
“Initiation of the pivotal trial is a huge milestone in the development of this novel therapy to treat obstructive sleep apnea,” McKhann said.
The company’s implanted device senses respiration and accordingly stimulates the hypoglossal nerve such that the tongue is forced toward the front of the mouth. Obstructive sleep apnea occurs when the tongue folds backward during sleep thereby blocking the airways. Standard therapy includes wearing continuous positive airway pressure masks, but patient compliance has been an issue. Apnex’s device aims to be an alternative to this treatment regimen.
Inspire Medical Systems, another Minnesota firm whose product is technologically similar to Apnex, is slightly ahead of Apnex Medical and a San Diego company, ImThera Medical, in that it won FDA clearance on a pivotal trial earlier this year. Inspire’s trial will enroll an estimated 480 patients, and including a one-year follow-up, is expected to completed in April 2013, according to ClinicalTrials.gov.