Appendix 4C - quarterly
- Global manufacturing and distribution agreements signed with the world's largest dental prosthetic provider, Modern Dental Group.
- US 510k FDA clearance for the O2Vent W, the winged device incorporating Oventus innovative airway technology.
- $7.0 million raised in successful $0.36 per share initial placement.
- Funds will be used to execute distribution plan with Modern Dental, complete clinical trials currently in progress and finalise development of products for the sleep clinician channel.
- Significant clinical progress made in the integration of Oventus' proprietary airway technology in the O2Vent with a positive airway pressure connection.
- Prudent management of spend to execute company strategy will continue.
The company's cash position as of 30 June 2017 was $8.6 million, following the successful completion of a capital raise of $6.5 million via an initial placement at $0.36 per share with up to a further $0.5 million subject to shareholder approval. Additional funds are being raised via a shareholder purchase plan.
The capital raised, along with the operational and regulatory achievements during the quarter, will enable Oventus to continue to execute its strategy to commercialise its proprietary airway technology.
The milestones delivered during the quarter, which include the global distribution and manufacturing agreements with Modern Dental, and expansion of the product base with the FDA clearance of the O2Vent W Winged device, are integral to the company's growth plans.
The company's global distribution agreement with Hong Kong Stock Exchange listed, Modern Dental Group (HKG:3600), provides access to one of the world's largest dental prosthetic device provider with over 70 sales and customer service centres covering North America, Europe, Australia, and the Greater China regions.
Oventus and Modern Dental will work together on marketing and sales of the Oventus devices, via the Modern Dental network. Modern Dental has exclusive rights in the US, and non-exclusive distribution rights in the rest of the world. The two companies have also entered into a co-manufacturing agreement.
"We are very pleased to have Modern Dental as our go to market partner and exclusive distributor in the US. Modern Dental has market leading positions in Europe and Australia, and a very strong presence in the US, servicing a quarter of all dentists, via its laboratory business Microdental."
"The manufacturing agreement with Modern Dental is also important, as it will enable us to scale up manufacturing for a global market, at a lower cost. Over the next few months we will be working closely with Modern Dental to put in place the systems, training and marketing to ready us to begin ramping up sales from the October quarter, with the US as the main area of focus initially." said Neil Anderson, CEO of Oventus.
"Management is also looking very closely at cash burn, and we are very focused on areas where we can reduce spend without hampering the ability to ramp up sales, over the course of 2018."
Oventus will enter the US market with two of the most important popular mandibular advancement mechanisms integrated with the airway technology available for sale in the US, following receipt of FDA clearance US FDA 510k clearance for the O2Vent W, the winged device incorporating Oventus innovative airway technology, in July.
Clinical Trial Program
Significant progress has been made by Oventus in the execution of its clinical trial program to advance the validation of its proprietary airway technology in its appliance line, including:
- A peer reviewed article on the O2Vent Mono has been accepted for publication by the Journal of Dental Sleep Medicine.
- The Brisbane clinical trial assessing the value of mandibular advancement with the Oventus airway technology is fully recruited.
- The Perth clinical trial examining the physiological effect of the Oventus airway is now underway.
The results from these clinical studies are expected by the end of the 2017 calendar year.
Additionally, Oventus presented encouraging results of its pilot study into the physiological effects of O2Vent T on pharyngeal pressure swings which cause the airway to collapse of obstructive sleep apnoea, to the American Academy of Dental Sleep Medicine in Boston.
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
Modern Dental Group Ltd