Rhinomed Ltd (ASX:RNO) has registered its revolutionary new Pronto rechargeable vapour release technology with both the US Food and Drug Administration (FDA) and the Australian Therapeutic Goods Administration (TGA) as a class-one medical device.
In the US, Rhinomed has now completed registration of Pronto covering both variants – Pronto Sleep and Pronto Clear – as a class-one medical device with the FDA.
The company also confirmed registration of Pronto as a class-one medical device with the TGA in Australia, using Rhinomed’s existing TGA listing under the same product category as its Mute and Turbine products.
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The new Pronto OTC range includes the novel Airstream release systems, which allows the continuous release of an essential oil blend into the nasal airstream over a set period.
By combining this new vapour release technology with the Mute’s stenting action, Rhinomed provides users with a unique dual action device that not only improves nasal airflow but delivers a soothing blend of essential oils to help clear a stuffy nose.
Pronto also includes a novel recharging and storage case that allows Pronto to be recharged before each use.
The company is completing production and will be shipping the new products at the end of May and confirms that both products will be sold online through select retail partners.