Successful completion of Oventus clinical trial for sleep apnoea mouthguard
A ground-breaking medical mouthguard invented by a Queensland dentist is poised to take on the world sleep disorder market following highly successful clinical trial results released today.
The Oventus Clearway DeviceTM is the first and only sleep therapy device in the world which allows air to flow through to the back of the throat bypassing nasal, soft palette and tongue obstructions.
The brainchild of Brisbane dentist Dr Chris Hart, the 3D-printed lightweight titanium mouthguard is the first of its kind to target moderate to severe sufferers of sleep apnoea.
Sleep apnoea is a condition where the air passage in the throat becomes obstructed during sleep and causes people to stop breathing and affects more than one million people in Australia.
Dr Hart said the number of people suffering from sleep apnoea was growing in line with an ageing population and obesity rates.
“There is a direct link between obesity and sleep apnoea,” said Dr Hart.
It can be related to high blood pressure, stroke, irregular heartbeats and diabetes.
Two years ago Dr Hart, himself a sleep apnoea sufferer, was motivated to find an oral device that worked better and was more comfortable than the current market alternatives.
Using his expertise as a dentist, he devised an oral mouthguard that incorporated an airway that would increase airflow and bypass obstructions of the nose, tongue and soft palate.
“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.”
In clinical trials, the Oventus Clearway DeviceTM has shown a 50 to 90 per cent reduction in Apnoea Hypopnea Index (AHI) in 75 per cent of patients (50 per cent AHI reduction is deemed a success in oral device therapy patients).
The primary results demonstrated patients used the device for 93 per cent of sleep time, more than five nights a week. In addition, 93 per cent of patients wanted to continue using the device and 100 per cent said they would recommend it to family and friends.
“The Oventus Clearway DeviceTM was developed with a secondary airway incorporated to assist patients with nasal obstruction who were previously unable to tolerate or respond to treatment with oral appliance therapy, to receive treatment for sleep disordered breathing without the need for Continuous Positive Airway Pressure (CPAP),” said Dr Hart.
“The recent clinical data has shown that the Oventus Clearway DeviceTM is more effective than other oral appliances and has an effect on oxygen levels comparable to CPAP.
“This combination technology of the stand alone oral mouthguard, together with its ability to connect with a CPAP machine for more advanced treatment, puts this device in a class of its own.”
Oventus CEO Neil Anderson said the company had worked hard with the CSIRO to capitalise on the unique benefits of 3D metal printing technologies to develop the lightweight bespoke titanium product.
“Having input from the CSIRO has been a huge bonus,” said Mr Anderson.
“They have not only assisted us with the technology to develop the physical device but also provided tremendous insight into the bespoke software scanning of 3D printing and the business support that has led to the release of the Oventus Clearway DeviceTM.
“The Oventus Clearway DeviceTM offers these patients an easy, convenient and transportable device suitable for everyday use.
“It is also an option for people that cannot tolerate the CPAP mask as a stand-alone device or, with connection to CPAP, to replace the mask.
“We look forward to bringing this revolutionary product to the world market.”
The Oventus Clearway DeviceTM is registered with the TGA and currently on the market in Australia.
For more information please contact:
Phillipa Thorn, Oventus Marketing Communications Coordinator, 0404 839 848, email@example.com
Oventus is a Brisbane-based medical device company that aims to be a world-leading designer, manufacturer and marketer of oral devices that provide increased airflow to people with snoring and associated sleep disorders. The company’s lead product is the Oventus Clearway DeviceTM, a world leading sleep therapy that allows air to flow through to the back of the throat and bypasses, nasal, soft palate and tongue obstructions. For more information on Oventus, visit www.oventus.com.au.