Rhinomed secures FDA and TGA registration for Pronto vapour release product

Rhinomed ASX RNO FDA TGA Pronto rechargeable vapour Mute
Rhinomed plans to begin shipping its Pronto devices by the end of the month.

Airway technology product developer Rhinomed (ASX: RNO) has secured US Food and Drug Administration and Australian Therapeutic Goods Administration registration for its Pronto vapour release technology.

The Pronto rechargeable vapour release unit has now been approved as a class I medical device with both countries’ regulators.

Based on Rhinomed’s existing BreatheAssist stenting nasal dilator technology, Pronto comprises the Airstream release system that allows a continuous release of an essential oil blend into the nasal airstream over a set period.

When incorporating the stenting technology into the Pronto vapour release unit, users are provided with a unique dual action device that improves nasal airflow and offers a soothing blend of pure essential oils that are traditionally known to help clear a stuffy nose or assist with enhanced natural sleep.

Pronto includes a recharging and storage case to keep the device charged and replenished with essential oils before each use.

Shipments of Pronto will begin before the end of the month.

Pronto markets

Pronto comes in two variants, with one targeting the US$28 billion global sleep aid market and the other addressing the US$34 billion nasal congestion, cough, cold and allergy market.

Rhinomed has already received a purchase order from an undisclosed retailer for more than 2,800 packs of its sleep aid Pronto product.

The company anticipates stock will be on store shelves by August this year, with revenues from the new product ranges anticipated to make an impact in the second quarter of the 2020 financial year.

Rhinomed noted the pricing details of these products will remain confidential at this stage.

“Rhinomed is delivering on its potential as a world leading innovator in nasal, respiratory, sleep and drug delivery markets,” Rhinomed chief executive officer Michael Johnson said.

“Its now time we start leveraging our platform to deliver drugs and formulations into specific target markets.”

“The global sleep aid and decongestant market are multi-billion dollar markets that have a clear need for innovation,” Mr Johnson added.

Rhinomed is also evaluating other uses for its technology including tailoring it to suit specific drug formulation and drug delivery profiles such as low dose, long release or high dose, fast acting.

By midday, shares in Rhinomed were up 14.29% to $0.24.

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