Novita Healthcare (ASX: NHL) has received US Food and Drug Administration (FDA) class cation for its TALI Train product paving the way for its commercial release into the US market.
According to Novita, the FDA has classified TALI Train as a class two medical device, exempt – allowing the product to be sold in the US without further clinical trials.
TALI Train is a drug-free digital platform designed to assist development in children aged three-to-eight which have been diagnosed with attention difficulties including autism, ADHD and other non-clinical problems.
The digital platform works by using proprietary algorithms to strengthen children’s core attention using an adaptive and a fun game-based interface.
Novita now plans to launch TALI Train into the US market in 2019 and is advancing discussions with potential partners in the region.
“Attention disorders and difficulties among children are a major issue across the world and the US is no exception,” Novita managing director Glenn Smith said.
“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,” Mr Smith added.
Researchers believe that attention problems account for the most common childhood difficulty. The US Centre for Disease Control and Prevention estimates the number of children with ADHA was 6.1 million in 2016.
Of those, almost 70% aged six, seven and eight were on medication for the disorder.
Novita’s subsidiary TALI Health devised TALI Train as a drug-free early intervention treatment option for clinicians, educators and partners.
It is also designed to complement existing treatments, including psychostimulants.
TALI Train is currently available in Australia and is delivered as a software as a service model for interest stakeholders.
The program is a five-week intervention that can be accessed on tablet devices.
Novita is also creating TALI Detect which will be a game-based assessment tool to screen children and evaluate their attention skills for early diagnosis and treatment.
The company anticipates TALI Detect will be released in 2019.
By mid-afternoon, shares in Novita had surged more than 24% to $0.041.