Oventus Medical Ltd. said the U.S. Food and Drug Administration approved its oral device to treat people with obstructive sleep apnea.
Obstructive sleep apnea occurs when one's throat muscles relax at irregular intervals and block the airway during sleep. A noticeable symptom of this type of sleep apnea is snoring.
Oventus's dental device, O2Vent Optima, is a customized 3D printed nylon oral appliance that provides a separate airway to stabilize the upper airway of obstructive sleep apnea patients.
The latest regulatory approval follows the launch of the product in Canada and Australia. Oventus had raised A$9.3 million in July to further the rollout of its sleep treatment devices, including O2Vent Optima.
O2Vent Optima is one of the devices under the company's sleep treatment platform, another being ExVent valve accessory that is already available in Canada and Australia and is awaiting approval in the U.S.
