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Oventus Announce FDA Clearance for O2Vent Optima Oral Device

Oventus receives US FDA clearance for O2Vent® Optima oral device

Key points:

  • Oventus receives US FDA clearance for O2Vent® Optima oral device
  • Clearance enables Oventus to commence sales of the device in the US market and officially launch recently announced material agreements with three US sleep groups
  • FDA clearance follows the launch of the O2Vent® Optima in Australia and Canada earlier this year
  • With key regulatory clearances in place, Oventus expects to secure further agreements across its key target markets in the US, Canada and Australia over the next 12-24 months, with a view to significant scaling through to the end of CY2019 and CY2020; negotiations ongoing with multiple groups
  • Oventus is strongly positioned to scale sales substantially following its recent Placement and Entitlement Offer which raised a total of A$9.3m
Brisbane, Australia 2 September 2019: Oventus Medical Ltd or the Company (ASX: OVN) is pleased to announce that it has received regulatory clearance from the US Food and Drug Administration (FDA) for its O2Vent® Optima oral device.

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