Receives FDA Clearance for the O2Vent W
- US 510k FDA clearance for the O2Vent W - winged or dorsal flex appliance - achieved; allowing sale of the appliance into the US.
- The O2Vent W will be distributed exclusively in the US by Oventus' distribution partner Modern Dental - which covers approximately one quarter of US dentists through 34,000 dental offices.
- First sales are planned for this quarter and expected to ramp up from the October 2017 quarter.
- The Winged device will allow dentists who prefer this type of mandibular advancement mechanism, to deliver appliances with the proprietary Oventus Airway Technology.
- Oventus now has O2Vent appliances on the US market with the two (2) most popular mandibular advancement mechanisms.
The clearance marks an important milestone for Oventus: With a US distribution partner recently signed, and appliances with the two most popular mandibular advancement mechanisms now cleared for sale, the company will focus on ramping up US sales. The US National Institute of Health estimate 12-18 million US adults have sleep apnoea (see Note below) with at least 80% of these estimated to be outside of care or not treated effectively with other therapies.
Oventus Managing Director and Chief Executive Officer, Neil Anderson said: "The O2Vent W is important to the Company's product plans and follows the recent signing of Modern Dental as a global distribution partner."
He added, "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.
About Oventus Medical Ltd
Oventus Medical Ltd (ASX:OVN) is a Brisbane, Australia, based medical device company that has commercialized and brought to market a new sleep treatment platform for the treatment of sleep apnoea and snoring that enhances the treatment outcomes of both oral appliance therapy and CPAP therapy through increased efficacy and greater adherence.
Oventus Medical Ltd