A Brisbane medical device company is poised to take on the world sleep disorder market with a US launch of its bespoke mouthguard.
Oventus Medical will preview their O2Vent device this week at the American Academy of Dental Sleep Medicine’s 25th Annual Meeting (June 9-11) and at Sleep 2016 (June 11-15) – the world’s largest scientific meeting dedicated exclusively to sleep medicine and sleep research – which both take place in Denver.
The US is a significant market for anti-snoring devices, with the US Sleep Foundation1 estimating that 37 million Americans regularly suffer from snoring, while the US National Institutes of Health2 estimate 12-18 million US adults have sleep apnoea.
The global sleep-disordered breathing market is estimated to be worth $50 billion annually.
The O2Vent is a 3D-printed titanium device custom-fitted to a patient’s mouth. Engineered with a separate airway, it directs air to the back of the mouth – bypassing 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 510k cleared and ARTG listed device, which was developed by Australian dentist Dr. Chris Hart, Oventus’ founder and clinical director, is designed to reduce or eliminate snoring and Obstructive Sleep Apnoea (OSA).
A recent clinical study of the O2Vent in Australia demonstrated that snoring was eliminated in 82 percent of patients and significantly reduced in all 100 percent of patients in the trial3. Positive results were seen in people who had nasal obstructions and mainly breathed through their mouths, including when they were asleep.
“People using other oral devices have major issues with them including chronic jaw pain, teeth loosening, teeth wear, ongoing adjustment, or nasal obstruction which stops many of them wearing their device,” said Dr Hart.
“As a sleep apnoea sufferer myself, I knew there had to be a better alternative that could increase airflow past the soft palette and tongue, that had fewer side effects.”
The O2Vent™ is currently the only device available with a unique separate airway incorporated into its patented design to improve airflow in people with snoring and associated sleep disorders.
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.”
“These results mean that a greater number of patients who snore or who suffer from mild to moderate sleep apnoea who are CPAP intolerant, now have an alternative treatment option available.”
In March 2016, the device received 510k clearance (K160234) in the USA. The device already is entered in the ARTG (ARTG 230890) in Australia since 2014 and is on market and generating revenue for the company. The device is expected to be available for sale in the US later this year.
3 Oventus Clinical Trial Report. Data on file.