What You Should Know:
– EarliTec Dx, a digital health company developing novel diagnostic and therapeutic products for children with Autism Spectrum Disorder (ASD) and early childhood vulnerabilities, today announced a $19.5 million financing led by Bernie Marcus, with participation from the Georgia Research Alliance (GRA).
– This round of financing will be used to support filing with the U.S. Food and Drug Administration (FDA) for 510K clearance, as well as commercialization of the company’s first product, the EarliPoint® Evaluation for ASD, which received breakthrough status in April 2021.
Why It Matters
Affecting roughly 1 in 44 children, Autism Spectrum Disorder (ASD) is more prevalent than all childhood cancers, juvenile diabetes and heart disease combined. While many parents suspect symptoms of autism before twelve months of age, the median age for diagnosis in the U.S. remains 4-5 years of age. Lack of access to expert clinicians and other disparities can extend the age at which a child is diagnosed. Prolonged identification delays the possibility of treatment in a situation where early intervention is one of the most important factors for improving lifetime outcomes.
The EarliPoint® Evaluation for Autism Spectrum Disorder is an investigational device utilizing Dynamic Quantification of Social-Visual Engagement (DQSVE), to capture moment-by-moment looking behavior imperceptible to the human eye. For a child, it is as simple as watching a video — like scenes of toddlers playing — while the device assesses the individual focal points at a rate of 120 times per second. Each data point is then compared to thousands of discrete measurements within a clinically validated database, to provide a timely, objective and accurate read of potential developmental disabilities.
Completed Clinical Trails
With technology developed by leading researchers at Children’s Healthcare of Atlanta, Emory University School of Medicine and Yale University, the company has completed clinical trials with more than 1,500 children—receiving breakthrough status for the EarliPoint® system in April of last year. This round of financing will be used to support filing with the U.S. Food and Drug Administration (FDA) for 510(k) clearance, commercialization and expansion of EarliTec’s digital biomarkers built on a proprietary multimodal AI platform.
“EarliTec’s ability to measure clinically relevant responses to unscripted social situations is revolutionizing our understanding of the way in which young children with autism learn about their social world,“ said Tom Ressemann, CEO of EarliTec. “With this insight, we can help parents, providers and caregivers, access earlier diagnosis at a time when effective intervention dramatically improves lifetime outcomes.”