Prepares for sales ramp up with expanded product range, distribution agreements
Audited Financial Statements & App. 4E
The focus this year has been on four main areas - product development, clinical trials (both new products and additional product validation) and regulatory approvals, as well as market development and market access. These will lay the foundation for sales ramp up. Oventus reported revenue of $447,994 for the 12 months to June 30, 2017, and a net loss after tax of $6,510,114.
Notably, Oventus entered into a global distribution agreement with Modern Dental, the world's largest provider of dental prosthetic devices, with over 70 sales and service centres covering North America, Europe, Australia and the Greater China region.
The two companies have also established a co-manufacturing agreement for the O2Vent product range. Modern Dental group has extensive expertise in the manufacture of dental appliances, holding the required quality management manufacturing certifications, including contract manufacturer registration with the FDA in the US. It will enable Oventus to scale up manufacturing cost effectively for a global market.
Modern Dental has exclusive marketing rights to the Oventus product suite in the US, and non-exclusive rights in the rest of the world. Plans are now underway for a US launch in October 2017, with training and marketing development activities now in progress.
With the O2Vent W, the winged, or dorsal flex appliance cleared for sale to the US with the FDA, Oventus and Modern Dental will enter the US market with Oventus' proprietary airway technology integrated into the two most commonly used mandibular advancement methods. This will enable us to cater to the large section of dentists who prefer a winged styled device for mandibular advancement.
Oventus Medical CEO and Managing Director, Neil Anderson, said "Oventus' unique airway technology provides a solution that can significantly improve outcomes for patients with snoring, and/or sleep apnoea. Based on the learnings we have gathered from our customers and being in the field, our focus this year has been to ensure we have the vital elements in place to accelerate market adoption, from the right product strategy to alignment with a credible partner, in Modern Dental that will facilitate our global expansion.
"We also continue to advance our clinical trial program, further validating the benefit of the airway technology, and supporting the development of our CPAP connection which opens another market opportunity, into patients who currently do not or do not comply with CPAP treatment. This product is expected to be launched in 2018, pending regulatory approval."
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About Oventus Medical Ltd
Oventus Medical Ltd (ASX:OVN) 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.
A clinical study completed earlier this year showed the company's first generation product the O2Vent Mono(TM) is successful in treating OSA and that snoring was either eliminated or significantly reduced to 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. It also improves oxygen levels for patients.
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.
Continuous positive airway pressure (CPAP) is the most definitive medical therapy for obstructive sleep apnoea, OSA, however many patients have difficulty tolerating CPAP. Oral appliances have emerged as an alternative to CPAP for obstructive sleep apnoea treatment.
Oventus Medical Ltd