Australian medical device company, Oventus Medical Ltd., has received clearance from the U.S. Food and Drug Administration (FDA) for the O2VENTTM device, an oral appliance intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnoea (OSA).
The clearance marks an important milestone for Oventus, validating the company’s technology as it prepares to target international markets, including the US.
The US is a significant market for anti-snoring devices, with the US Sleep Foundation estimating that 37 million Americans regularly suffer from snoring, while the US National Institutes of Health estimate 12-18 million US adults have sleep apnoea.
The global sleep disordered breathing market is estimated to be worth $50 billion annually.
Oventus Managing Director and Chief Executive Officer, Neil Anderson said:
The O2VENT is the Company’s first medical device to receive FDA clearance, and 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 Dr Chris Hart, 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 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 unique in its innovative design and is protected by a strong portfolio of patent applications (IP).
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 recent clinical study in Australia showed the O2VENT is successful in treating OSA and that snoring was either eliminated or significantly reduced in 100 per cent of patients. The positive results included those people who had nasal obstructions and mainly breathed through their mouths, including when they were asleep.
Dr Hart said:
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.