Titratable sleep apnoea device cleared by FDA

Australian medical device company Oventus Medical (ASX:OVN) has received clearance from the US FDA for the O₂Vent T device, an oral appliance intended to alleviate snoring and obstructive sleep apnoea (OSA). The clearance allows Oventus to launch into the US, where it will target the 12–18 million US adults currently estimated to have sleep apnoea.

The product is a 3D-printed titanium mandibular (jaw) advancement device fitted in a patient’s mouth. It has an airway that directs air to the back of the throat and bypasses nasal, soft palate obstructions and tongue obstructions. The device is already registered with the TGA in Australia and generating revenue for the company.

A clinical study completed earlier this year showed the company’s first-generation product, the O₂Vent Mono, was successful in treating OSA and that snoring was either eliminated or significantly reduced in 100% of patients. This included those who had nasal obstructions and mainly breathed through their mouths.

Although the O₂Vent Mono was cleared by the FDA back in April, Oventus’s second-generation titratable device, the O₂Vent T, will be the first of its products launched in the US. The company expects the O₂Vent T to have similar or even superior results to its predecessor as the jaw position can be more optimised through the titration mechanism.

Oventus Medical (ASX:OVN) shares were trading 6.29% higher at $0.76 as of around 3 pm on Monday.