O2Vent Optima Launch in Canada
O2Vent Optima Launch in Canada
Brisbane, Feb 4, 2019 AEST (ABN Newswire) - Oventus Medical Ltd (ASX:OVN) is pleased to announce the Canadian launch of the O2Vent(R) Optima device which treats both the potentially fatal condition, obstructive sleep apnoea (OSA) and snoring. The device launch in Canada follows the successful completion of a controlled market release, with early results demonstrating strong patient acceptance.

Key points:

- O2Vent(R) Optima oral device for the treatment of sleep apnoea and snoring launched in the Canadian market

- Follows the successful Australian launch in January; with US launch to follow pending 510(k) approval from the US FDA

- O2Vent(R) Optima is a compact nylon, lightweight addition to the Oventus 'Sleep Treatment Platform' with a reduced cost of goods in comparison to the original titanium O2Vent(R)

- O2Vent(R) Optima incorporates proprietary Oventus Airway Technology and is compatible with Oventus ExVent(TM) valve technology which will also be launched in 2019

- Clinical trials have shown that the proprietary Oventus Airway Technology alone, or in combination with ExVent(TM) valve technology, dramatically improves treatment outcomes for sufferers of obstructive sleep apnoea

The O2Vent(R) Optima is the newest product in the O2Vent(R) oral device range within Oventus' Sleep Treatment Platform. Its Canadian launch follows the news in January this year, that the O2Vent(R) Optima had been launched in the Australian market.

The O2Vent(R) Optima is a customised 3D-printed nylon oral appliance that advances the jaw forward to open the airway and incorporates the proprietary Oventus Airway Technology to improve the effectiveness of oral appliance therapy. This device is lighter than the original O2Vent(R) and less complex to make. The combination of reduced material costs and reduced manufacturing times lowers the cost of goods and will shorten timeframes on delivery of devices to patients.

"We are excited to be launching the O2Vent(R) Optima in Canada following strong early feedback from the local market. The O2Vent(R) Optima fills a void that currently exists for patients who are struggling with, or refuse to use CPAP therapy. There is also a large group of patients who have not responded to other kinds of oral devices, who now have an alternate treatment option.

What sets our Sleep Treatment Platform apart is the unique Oventus Airway Technology that enables airflow. It has been shown to bypass obstructions of the nose, tongue, soft palate and lateral walls of the airway, which means it is effective for a broad range of patients. In clinical trial settings, the technology has been demonstrated to bring relief to many patients who have had little success with other treatment options," said Oventus Managing Director and CEO, Dr Chris Hart.

The O2Vent(R) Optima is the first of two new products coming to market in 2019. The US product launch is expected in Q2CY2019, pending 510 (k) regulatory clearance from the US FDA.

The second product is a valve that integrates with select O2Vent(R) devices to naturally improve airflow and airway stability. The valve is called the ExVent(TM) and has been clinically proven to dramatically increase the success rates of traditional mouthguard devices for sleep apnoea sufferers.(see Note below)

The ExVent(TM) was developed in collaboration with the CSIRO and Neuroscience Research Australia (NeuRA) during the three-year, A$2.95 million Federally funded Cooperative Research Centres Project grant. ExVent(TM) is due to be released in Australia during Q1CY2019.

Following the Australian release of ExVent(TM), the product will be launched in North America and Europe.

Note: Lai V, Tong B, Tran C, Ricciardiello A, Donegan M, Murray N, Carberry J, Eckert D. Combination therapy with mandibular advancement and expiratory positive airway pressure valves reduces OSA severity. Poster and abstract presented at ASA Sleep Down Under, Brisbane 2018.

About Oventus Medical Ltd

Oventus Medical Ltd (ASX:OVN) is a Brisbane based medical device company that is commercialising a unique treatment platform for the treatment of sleep apnoea and snoring. Unlike other oral appliances or CPAP interfaces, the Oventus devices have a unique and patented airway within the treatment platform that allows air to flow to the back of the mouth unobstructed while maintaining an oral seal and stable jaw position, bypassing multiple obstructions from the nose, soft palate and tongue, reducing airway collapsibility and managing mouth breathing while maintain a stable airway with or without nasal CPAP. 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, this technology actually manages mouth breathing by converting it to device breathing and normalising ventilation. The O2Vent(TM) 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.

For more information on Oventus' Sleep Treatment Platform, please visit http://www.oventus.com



Dr Chris Hart
Managing Director and CEO
M: +61-409-647-496

Jane Lowe
IR Department
M: +61-411-117-774 or
E: jane.lowe@irdepartment.com.au

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