Oventus Medical (ASX:OVN) talks FDA clearance and agreement with Modern Dental

Interviews

by Carolyn Herbert

Oventus Medical Limited (ASX:OVN) Founder and Clinical Director Dr Chris Hart discusses FDA clearance for the company's O2 Vent W model and its agreement with leading global dental prosthetic device provider Modern Dental.


Carolyn Herbert: Hello I’m Carolyn Herbert from the Finance News Network and joining me from Oventus Medical Limited (ASX:OVN) is Founder and Clinical Director, Dr Chris Hart. Chris, welcome back.

Dr Chris Hart: Thanks Carolyn.

Carolyn Herbert: Oventus Medical makes mouthguards to help people with sleep apnoea related disorders. How does your product fit into the market?

Dr Chris Hart: A lot of people are aware, as you may be, that there are two main treatments for sleep apnoea and snoring. One’s a mask with a reverse phase vacuum cleaner that pumps air in to inflate, or splint the airway to stop it collapsing. And the other type of treatment is a mouthguard that brings the jaw forward, to stop the tongue from falling back into the back of the throat.

What we’ve done is we’ve developed an airway 3D printed in titanium. And as well as bringing the jaw forward, this airway allows the air to travel through the airway and exit straight into the back of the throat unobstructed. So if you look at the sites of collapse, only about 20 per cent of them occur at the tongue base. The rest are soft palate lateral collapse, or caused by nasal obstruction as well, or worsened by nasal obstruction. So with the airway, we bring the jaw forward to stabilise the tongue base. But we’re also bypassing the upper airway resistance in the nose, soft palate collapse and the tongue as well.

So this technology has shown in our clinical trials that by allowing the air to pass through this airway, it’s having a very similar effect to pumping with a CPAP. Having said that, for very severe patients, they may require still a little bit of positive pressure. And what we’ve found if we use this as an interface, we’re reducing pressure by two thirds and doing it without a mask. So the main problems with people adhering to CPAP, is too much pressure in the mask. So we’ve pretty much dealt with those objections for the patients that are outside of care.

Carolyn Herbert: Now to FDA clearance of your O2Vent device. Where are you at with that?

Dr Chris Hart: So we have three devices now cleared in the US. Our original device the Mono and then we have what we call the O2Vent T, which is one style of advancing the mandible and now we have the W as well. So what we can do, because of our IP position, we have very strong IP around our airway technology. So we can incorporate that airway into all our competitors’ devices that they can’t. So we’ve now developed two out of the three main types of products that are used in the market, by dentists. The third one will be in market within the next six months.

What that means is dentists across the world will have the choice of any type of oral appliance they like, with our airway technology in it. And again, our clinical evidence has shown the large percentage of patients have a very significant benefit, by incorporating this airway technology. So in effect, we can service a large percentage of the market unopposed, using whatever style of device the dentist prefers.

Carolyn Herbert: Now to your agreement with Modern Dental Group Limited. Who are they and can you tell us a bit more about them?

Dr Chris Hart: That’s a watershed moment for us in reality. Modern Dental are by far the largest manufacturer and distributor of dental prosthetics in the world. They’re number one, two or three in every major market, very low cost manufacturer with huge distribution channels. So we’re really lucky to be working with them and distributing our products, through their distribution channels. They have 53 labs on every major continent as well as a huge presence in Asia.

Carolyn Herbert: So what sort of volumes are you expecting to sell?

Dr Chris Hart: So we’re putting together now the implementation plan to start selling with Modern. That’ll run through to the end of this year. Probably within three to six months, we’ll start to see sales increasing. Within those distribution agreements, we’ve factored in the ability to get to cash positive within 2019. So I think we’ll see a significant ramp up through calendar year 2018.

Carolyn Herbert: Finally Chris. What can shareholders expect in terms of news flow going forward?

Dr Chris Hart: I think we should be looking out for the implementation of the Modern distribution agreements. So we’ll be starting to drive sales through Modern in Australia and North America, in the final quarter of this calendar year. And then starting sales in Europe as well in the first quarter of 2018. Along with that, we have a number of clinical trials underway. So we’ll be releasing clinical evidence through the end of this calendar year and early next year. But we’ll then drive clinical adoption and that’ll also then drive sales, as dentists and sleep physicians start to see the place in the market, for their patients of this technology.

We also have two or three more products coming to market in the next 12 months. So I would expect to see finalisation of the product line, growing clinical evidence and adoption by clinicians and sales increasing, through calendar year 2018.

Carolyn Herbert: Dr Chris Hart, thanks for the update.

Dr Chris Hart: Thanks Carolyn.


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