Oventus Medical gets set for US market after FDA approval for O2Vent Optima

Oventus Medical ASX OVN O2Vent Optima FDA approval Food and Drug Administration
Oventus Medical has received regulatory clearance from the US Food and Drug Administration for its O2Vent Optima oral device.

Medical device company Oventus Medical (ASX: OVN) has received a major boost in its bid to see the O2Vent Optima oral device being sold across the US.

Earlier today, Oventus announced that it had received regulatory clearance from the US Food and Drug Administration (FDA) for O2Vent Optima – the newest product in the O2Vent oral device range which forms a part of Oventus’ Sleep Treatment Platform.

The company makes a range of products that improve comfort during sleeping for patients suffering from various ailments including sleep apnoea and snoring, as well as secondary effects such as tooth decay and gum disease.

Oventus says its new product is a “customised 3D-printed nylon oral appliance” that provides obstructive sleep apnoea (OSA) patients with comfort and simplicity, including the addition of a separate airway that adds further stability for patients.

The new device is able to “titrate” – or in other words, continuously measure and adjust –patients’ lower jaw forward to a comfortable range, and thereby bypassing nasal congestion and mitigating other risk areas of airway collapse such as the tongue, soft palate and lateral walls of the airway.

Global expansion

The ultimate aim of O2Vent is to induce patients to breathe via the nasal passageway rather than the mouth.

Nasal breathing is more difficult when there is congestion, allergies, or other forms of obstruction. Mouth breathing is considered abnormal because it can lead to facial structural changes and skeletal alignment issues, as well as, tooth decay and gum disease.

“We are thrilled to have received FDA clearance, which enables us to sell the O2Vent Optima in the US – a core market for Oventus alongside Canada and Australia,” said Dr Chris Hart, chief executive officer of Oventus.

Following official approval from the FDA, the next stage is for the medical devices company to distribute its Optima devices across the US, by executing material agreements within the US market.

“With key regulatory clearances now in place and a robust cash balance following our recent capital raising, we are in a strong position to scale sales substantially across our key markets,” said Mr Hart.

Earlier this year, O2Vent Optima was launched in Australia and Canada, indicating a growing pipeline of markets and an expanding addressable audience for the companies sleep treatment products.

“Given the growing pipeline and a robust cash balance following the recent Placement and Entitlement Offer which raised a combined $9.3 million, Oventus is strongly positioned to significantly scale sales and expects to announce further agreements across its key markets over the next 12-24 months,” the company said.

Sleep market traction

Early adoption of the Oventus Sleep Treatment Platform is being driven by growing clinical evidence demonstrating that O2Vent technology can deliver “greatly improved treatment outcomes compared to current commercially available oral appliances”.

Oventus signed its first material contract in July of this year, with a US sleep medicine group that selected to adopt the Optima treatment platform in order to combat sleep apnoea across eight clinical treatment sites in several states. The contract stipulated that Oventus would see a minimum monthly quota of 20 O2Vent devices to be delivered to patients, per site.

Just last month, Oventus announced material agreements with two US sleep provider groups who agreed to adopt Oventus’ sleep treatment platform and “lab in lab” business model across a total of 10 facilities.

Oventus declared that the “lab in lab model delivers fast outcomes for patients within a framework that is commercially attractive for sleep therapy providers and dentists, a key driver of adoption.”

Under the agreements, Oventus became the exclusive supplier of dental sleep services for the treatment of OSA and must, therefore, meet a minimum monthly quota of devices for twenty different sites.

The flurry of material agreements in recent months means that when combined with the seven sites already announced in Canada, Oventus now has 25 sites under contract with the lab in lab program across North America.

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