The European regulatory authority has granted CE mark for Apnex Medical's hypoglossal nerve stimulation (HGNS) system, used to treat obstructive sleep apnea (OSA).
The approval was based on the positive results of two clinical studies conducted in the US and Australia.
The results demonstrated that the majority of patients had reduction in their OSA as well as substantial improvements in the quality of their sleep, quality of life, and overall health.
The 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.
The system detects the patient’s breathing and delivers mild stimulation to the hypoglossal nerve, which controls the muscles of the tongue, to keep the airway open.
The HGNS system is designed to work only when the patient is asleep through a handheld controller.
Apnex Medical president and CEO Chas McKhann said they are also focusing on further evaluation of the HGNS system in the Apnex Clinical Study, a randomized clinical trial of the HGNS system that is enrolling patients in the US, Australia and in select countries in Europe.