Australian medical device company Oventus Medical Ltd has received FDA 510k clearance for its O2Vent W device, an oral appliance intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnea (OSA).
With a US distribution partner recently signed and appliances with the two mandibular advancement mechanisms now cleared for sale, the company will focus on ramping up US sales.
Oventus managing director and CEO Neil Anderson says in a release, “The O2Vent W is important to the company’s product plans and follows the recent signing of Modern Dental as a global distribution partner. We now have the right product mix and right distribution partner to accelerate our launch into the lucrative US market. First sales of the winged appliance are planned for this quarter with ramp up from next quarter.”
Oventus will continue to expand its product range, noting that the Oventus positive airway pressure (PAP) connection currently in an advanced stage of development will be compatible with O2Vent W appliance for low pressure combination therapy.