Oventus ready to hit US market with oral device

Friday, September 6, 2019

BRISBANE, Australia – Oventus Medical has received regulatory clearance from the U.S. Food and Drug Administration for its O2Vent Optima oral device to treat obstructive sleep apnea. “We are thrilled to have received FDA clearance, which enables us to sell the O2Vent Optima in the U.S.—a core market for Oventus, alongside Canada and Australia,” said CEO Dr. Chris Hart. “We look forward to officially launching our material agreements within U.S. sleep channels and working with them to deliver the device to patients across their various treatment sites.” O2Vent Optima is a customized 3D-printed, medical grade nylon oral appliance that offers the comfort and simplicity of a mandibular advancement device, but with a separate airway that adds further stability to the upper airway throughout the night. Robin Randolph, the company’s senior vice president of sales and marketing, has introduced a dental-sleep program for sleep labs and HME providers who want to provide patient choice and/or an alternative treatment.