Oventus 4E – Platform In Place For Accelerated Growth

Key Points:

• Successful IPO Raised $12 million - strong institutional support
• Received FDA clearance for O2VentTM Mono device
• Launched next generation O2VentTM T device in Australia
• Manufacturing scale up in place
• Strong interest generated at major US sleep conference
• Early sales revenue encouraging
• Awaiting FDA clearance on 2nd device
• Technology breakthrough in our airway

Brisbane, Australia 25th August 2016: Medical device sleep apnoea and snoring disorder company Oventus Medical Ltd. (ASX: OVN) releases its first 4E. The company has established a platform for accelerated growth following a successful IPO raising $12 million and is reporting encouraging early revenue.

Oventus is focused on developing and producing oral appliances to treat obstructive sleep apnoea and snoring, especially in people who cannot be, or are not effectively treated with existing devices or therapies.

CEO Neil Anderson said, “The Company’s devices are 3D printed and feature a unique airway that channels air to the back of the throat, bypassing oral obstructions that cause sleep apnoea and snoring. We have established state of the art systems and processes that will drive growth for the company going forward.”

Oventus has reported early revenues of $540,164 for the 12 months to June 30, 2016 and achieved significant milestones which are driving the company forward.

The company received clearance from the US Food and Drug Administration (FDA) for its first generation device, the O2VentTM Mono, and has made an application for its second generation titratable device, the O2VentTM T.

Oventus launched the O2VentTM T in Australia and enrolled the first patient in a 40 patient clinical trial of the device. The trial will produce data around the comfort, safety and efficacy of the O2VentTM T, as well as the comfort and efficacy of the inclusion of an airway into an oral appliance. Oventus has a unique position with a patent protected device in the growing sleep disorder market.

A Scientific Advisory Committee of sleep, dentistry and ear, nose and throat experts has been established in Australia to advise on clinical trial design for Oventus’ current and future products.

Clinical Director and founder Dr Chris Hart said: “We believe obstructive sleep apnoea is a serious medical condition that requires a multidisciplinary approach to treatment. We look forward to working with the committee so that our devices achieve maximum patient benefit.”

Oventus has also established a 3D titanium printing facility at CSIRO in Melbourne and a production operation in Brisbane for polymer inserts and packaging.

The company is also making significant progress driving awareness for its products with attendance at Sleep 2016, a joint meeting of the American Academy of Sleep Medicine and the Sleep Research Society. There was considerable interest among attendees of Oventus’ technology and its potential to treat obstructive sleep apnoea.

For more information please contact:

Dr Mel Bridges, Chairman: M: 0413 051 600 (+61413051600)

Gavin Lower, WE Buchan: P: 03 8866 1215 or M: 0414 796 726

About Oventus

Oventus is a Brisbane based medical device company that is commercialising a suite of oral appliances for the treatment of sleep apnoea and snoring. Unlike other oral appliances, the Oventus devices have a unique and patented airway within the device that delivers air to the back of the mouth bypassing multiple obstructions from the nose, soft palate and tongue. They are particularly designed for the many people that have nasal obstructions and consequently tend to mainly breathe through their mouth. While it may seem counterintuitive, the device actually prevents oral breathing. The O2Vent is designed to allow nasal breathing when the nose is unobstructed, but when obstruction is present, breathing is supplemented via the airways in the appliance.

According to a report published by the Sleep Health Foundation Australia, an estimated 1.5 million Australians suffer with sleep disorders and more than half of these suffer with obstructive sleep apnoea.1

Continuous positive airway pressure (CPAP) is the most definitive medical therapy for obstructive sleep apnoea, OSA, however many patients have difficulty tolerating CPAP2. Oral appliances have emerged as an alternative to CPAP for obstructive sleep apnoea treatment.3

1 Deloitte Access Economics. Reawakening Australia: the economic cost of sleep disorders in Australia, 2010. Canberra, Australia.

2 Beecroft, et al. Oral continuous positive airway pressure for sleep apnea; effectiveness, patient preference, and adherence. Chest 124:2200–2208, 2003

3 Sutherland et al. Oral appliance treatment for obstructive sleep apnea: An updated Journal of Clinical Sleep Medicine. February 2014.

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