Rhinomed’s New Pronto™ Vapour Release Technology Registered With US FDA & Australian TGA

3 min read | May 17, 2019 08:12 PM AEST | By Team Kalkine Media

Rhinomed Limited (ASX: RNO), a medical technology company with a patented nasal technology platform, announced on 17 May 2019 regarding the registration of its revolutionary new Pronto™ rechargeable, dual action, vapour release technology with US FDA and the Australian TGA as a class I medical device.

On 15 April 2019, the leader in nasal technology announced the launch of its revolutionary new Pronto™ technology in the second half of 2019 after the receipt of initial purchase orders of Pronto Sleep from one of the leading drug store chains in the USA.

Based on the existing BreatheAssist™ nasal dilator technology of the company (including Mute™ and Turbine™), the new Pronto™ OTC range also has the novel Airstream™ release system that enables the release of an essential oil blend into the nasal airstream over a set period of time. When the new vapour release technology of the company combines with the stenting action of Mute, the unique dual action improves the nasal airflow and at the same time delivers a soothing blend of pure essential oils that clears a stuffy nose to sleep better naturally.

Besides, Pronto™ also includes a novel recharging and storage case. When Pronto™ is placed in the storage case in the recharge position, the device gets replenished with the essential oil formulation which is ready for using the product again.

Pronto™ range comes in two formulation variants - Pronto™ Sleep and Pronto™ Clear - addressing unmet needs in the global sleep aid market ($28bn) and global cough & cold and nasal congestion market ($34bn).

The registration of Pronto Sleep and Pronto Clear is now completed with the US FDA and Australian TGA as Class I medical devices.

At the end of May 2019, the company would be completing the production and shipment of the new products, to be rolled out into 900 stores. The company also confirmed that both the products would be sold initially online through select retail partners.

The company also confirmed that this unique and patented technology has a wide range of applications. Investigations with respect to the customization of the product to other formulations and specific drug delivery profiles like low dose/long release or high dose/fast acting are under process.

In the 1H FY2019 which ended on 31 December 2018, there was an increase in the revenue from the ordinary activities by 76.9% to $1,347,805. The company made a loss of $2,865,535. Besides, during the period, the company made a significant expansion of the US retail footprint. The Group also announced that Mute was being core ranged into more than 5000 US based stores. The total units shipped during the period was 112,682 with the sales value of $1,883,529.

The shares of RNO closed the day’s trading at A$0.210. RNO holds a market capitalization of A$29.81 million and approximately 141.93 million outstanding shares. The stock has soared up by 23.53% over last one month.


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