Australian medical device company Oventus Medical Ltd has received clearance from the US Food and Drug Administration (FDA) for the O2Vent T device, an oral appliance intended to reduce or alleviate snoring and obstructive sleep apnea (OSA).
The clearance marks an important milestone for Oventus, allowing the company to now launch into the United States.
Oventus managing director and CEO Neil Anderson says in a release: “The O2Vent T is the company’s first product to be launched into the United States. Its FDA clearance is consequently an important milestone for us as we strive to bring our innovative product portfolio to the global market to benefit those that suffer from OSA or snore excessively.”
The device, which was created by Brisbane dentist Chris Hart, M.Phil, BSc, BDSc, who founded Oventus and is the company’s clinical director, is indicated for use during sleep to aid in the treatment of snoring and OSA.
The O2Vent is a 3-D 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 already is registered with the Therapeutic Goods Administration (TGA) in Australia and is on market and generating revenue for the company. TGA registration also paves the way for launch into key European and Asian markets.
A clinical study completed earlier this year showed the company’s first generation product the O2Vent Mono is successful in treating OSA and that snoring was either eliminated or significantly reduced in 100% of patients (Oventus Clinical Trial Report. Data on file). The positive results included those people who had nasal obstructions and mainly breathed through their mouths, including when they were asleep.
Hart says: “The recent clinical data strongly supports its superior performance and clearly demonstrates its effectiveness in treating a range of sleep disorders. It also improves oxygen levels for patients. It means a greater number of patients who are CPAP intolerant or mild to moderate sufferers of sleep apnoea now have an alternative treatment option available.”
The company is expecting the titratable version, the O2Vent T to have similar or even superior results as the jaw position can be more optimized through the titration mechanism.