EarliTec Diagnostics Announces $19.5 Million Financing to Advance Autism Diagnosis and Treatment in Children as Young as 16 Months of Age

EarliTec Diagnostics Announces $19.5 Million Financing to Advance Autism Diagnosis and Treatment in Children as Young as 16 Months of Age

The Series A round was led by an affiliate of Bernie Marcus and Georgia Research Alliance and will support foundational work to make objective autism diagnosis and monitoring broadly accessible

ATLANTA, Feb. 18, 2022 – EarliTec Dx, Inc. (“EarliTec”), a digital health company developing novel diagnostic and therapeutic products for children with autism and early childhood vulnerabilities, announced today a $19.5 million financing to further its mission of making earlier autism identification and treatment accessible to children everywhere. Bernie Marcus led the Series A round with participation from the Georgia Research Alliance (GRA).

In 2021, the CDC reported that approximately 1 in 44 children in the U.S. are diagnosed with autism. Early identification and intervention are significant factors in improving lifetime outcomes for children with autism; however, limited access to skilled clinicians and other disparities often delay diagnosis until after the age of four.  EarliTec is the first company to use Dynamic Quantification of Social-Visual Engagement (DQSVE) to objectively diagnose autism and quantify individual severity at very early ages.

“The difference that early identification makes in securing help and support during a very difficult time is significant and can ultimately transform the lives of children with autism and their families.” said Bernie Marcus, co-founder of The Home Depot. “We are thrilled to be at the forefront of this innovation and to support the evolution of this technology.”

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.”

The EarliPoint™ Evaluation for autism 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.

ABOUT AUTISM & DELAYED DIAGNOSIS AND TREATMENT

Affecting roughly 1 in 44 children, autism 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 US 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.

ABOUT EARLITEC DIAGNOSTICS

EarliTec Diagnostics is a medical device company making earlier identification and treatment for autism and related disabilities accessible to children everywhere. Developed by leading researchers at Children’s Healthcare of Atlanta, Emory University School of Medicine and Yale University, EarliTec is pioneering development of biomarkers that help parents, providers and caregivers understand how a child is viewing the world. The company’s initial product, the EarliPoint™ Evaluation for autism received breakthrough status from the FDA as it seeks to be the first objective, clinically validated measure of individual autism status and severity in children as young as 16 months of age.

MEDIA CONTACT:
Laura Wagner
Health+Commerce
732-956-1687
laura@healthandcommerce.com

SOURCE: EarliTec Diagnostics, Inc.

Jamie Pagliaro brings over two decades of leadership in autism and behavioral health to his role as President and CEO of EarliPoint. Most recently, he served as Chief Operating Officer at Rethink, a leading SaaS provider supporting individuals with autism and developmental disabilities. Under his leadership, Rethink’s behavioral health division became the company’s largest business unit, serving thousands of clinicians and driving scalable, tech-enabled care delivery.

Earlier in his career, Jamie was Executive Director of the New York Center for Autism Charter School, the first public charter school in New York State dedicated to children with autism. At EarliPoint, he leads the company’s mission to bring breakthrough science to the front lines of care—empowering providers, families, and health systems with earlier answers and better outcomes.

Jamie Pagliaro

President & Chief Executive Officer

Dr. Ami Klin is a globally recognized leader in autism research and early detection. As Director of the Marcus Autism Center and Division Chief of Autism and Developmental Disabilities at Emory University School of Medicine, he has dedicated his career to understanding how young children engage with the social world—and how subtle disruptions in attention can signal developmental differences. His pioneering work in eye-tracking science led to the development of EarliPoint™ Evaluation, the first FDA-authorized tool to objectively assess autism in children as young as 16 months.
At EarliPoint, Dr. Klin drives clinical strategy and innovation, ensuring that families and clinicians worldwide have access to timely, science-based insights that enable earlier, more personalized intervention. His career reflects a deep commitment to transforming how society supports children with autism—starting with the earliest signs.

Ami Klin, PhD

Chief Clinical Officer & Co‑Founder