- Sleep-tech company Oventus has received U.S. FDA approval for its sleep apnoea device, O2Vent Optima
- The approval allows the company to begin selling its product in the U.S. market and launch pre-established supply agreements
- Shares in Oventus are up 11.46 per cent today, currently trading for $0.54 apiece
Sleep-tech company Oventus has received U.S. FDA approval for its sleep apnoea device, O2Vent Optima.
Getting the all clear from The States’ food and drug regulatory body, this allows the company to begin sales in the U.S. market.
Prior to the O2Vent being cleared by the U.S. federal agency, Oventus established supply agreements with American-based sleep groups, which can now officially launch.
CEO of Oventus Dr Chris Hart said: “We look forward to officially launching our material agreements within US sleep channels and working with our customers across their various treatment sites to deliver Optima devices to patients.”
After achieving regulatory approvals in the U.S., Oventus expects it will fast track its expansion across the The States, Canada and Australia. Over the next 12-24 months, the company is working to secure several supply agreements.
The O2Vent Optima is a custom, 3D-printed nylon oral appliance, resembling a mouthguard in appearance. It is designed to help patients with obstructive sleep apnoea by enabling unobstructed air to flow to the back of the throat.
Multiple clinical studies have proven this technology to be effective with more than 170 patients benefiting from it.
The company highlighted going forward it is secure in scaling sales significantly, due to $9.3 million raised from shareholders earlier in the year.
Shares in Oventus are up 11.46 per cent today, currently trading for $0.54 apiece, as of AEST 11:32 am.