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ASX-listed health and technology play Novita Healthcare (ASX:NHL) is now able to sell its flagship TALI Train product in the US market after receiving approval from the US Food and Drug Administration (FDA).

The TALI product will be able to skip further clinical trials of its product, aimed at early intervention for children diagnosed by ADHD without the need for psychostimulants.

The FDA approval means NHL will be on the lookout for a marketing partner in the US, with the approval meaning NHL can get to work without the need for further delay.

Calling the news a “major milestone”, NHL managing director Glenn Smith said the US was a potentially ripe market.

The US Center for Disease Control and Prevention estimates the number of children diagnosed in the US with ADHD was 6.1 million in 2016.

It also estimates 69 percent of children who are either six, seven, or eight years old are taking drugs to alleviate the symptoms of ADHD.

Early intervention treatment is not typically administered to children under the age of five due to the fear of its effects.

Given there are question marks over the long-term effects of such drugs in children, Smith said NHL’s drug-free solution was ideal in the US market.

“Given early intervention therapies have demonstrated value in treating children and improving attention, concentration and learning outcomes, we believe there is a significant market opportunity in the US for a validated treatment like TALI Train,” Smith said.

NHL has already set up an initial clinic in Singapore and an early childhood centre in Hong Kong, while it sells its solution under a SaaS model in Australia.


This content is produced by Star Investing in commercial partnership with Novita Healthcare. This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.