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EarliTec Diagnostics, Inc. Raises $21.5 Million in Series B Financing; Funds to Accelerate Commercialization of EarliPoint Evaluation and Further Product Development

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● Funding round led by Nexus NeuroTech Ventures and Venture Investors Health Fund

● New investment will advance R&D efforts of first-in-kind autism diagnostic and assessment tool in toddlers

ATLANTA & MINNEAPOLIS, April 2, 2024-- EarliTec Diagnostics, Inc. (“EarliTec”), a medical device company focused on diagnostic and therapeutic solutions for children with autism and related early childhood vulnerabilities, announced today a $21.5 million Series B financing round, led by Nexus NeuroTech Ventures and Venture Investors Health Fund. The funds will be used to expand commercialization efforts and advance clinical research for the first-in-kind EarliPoint™ Evaluation (“EarliPoint”), which aids clinicians in the diagnosis and assessment of autism in children aged 16-to-30 months.

"EarliTec is pioneering diagnostic and treatment solutions for children with autism, and we're thrilled to support their innovative efforts," said Jim Adox, Executive Managing Director at Venture Investors Health Fund.

"This funding round will enable EarliTec to further advance their groundbreaking technology and expand access to their transformative solutions," said William Marks, M.D., Chief Medical Officer at Nexus NeuroTech Ventures.

Despite autism being one of the most prevalent childhood conditions, with an estimated 1 in 36 children having autism per the CDC, limited access to diagnosis and treatment options compromises outcomes. EarliPoint is the first personalized, quantifiable, and objective tool for children aged 16 months to 30 months suspected of having autism.

During an EarliPoint evaluation, children watch videos of social interactions on a portable tablet, and the embedded biomarker tracks how the child focuses on the scenes, proxies expert clinician diagnosis, and assesses the level of function on the core characteristics of autism–social disability, verbal ability, and non-verbal learning.

"There is a severe unmet need in autism diagnosis, and families often face a challenging path to diagnosis of autism due to the lack of innovation in the space and limited access to expert clinicians," said Ami Klin, Ph.D., Chief Clinical Officer and Founder of EarliTec, Director of Marcus Autism Center and Professor and Chief at Emory University School of Medicine. "EarliPoint represents a meaningful step forward in better, accessible care for autistic children. For the first time, clinicians have a tool to objectively understand where a child is on the spectrum, reach a diagnosis, and deliver personalized care.”

EarliTec will use this funding for EarliPoint’s commercialization, to complete studies that will evaluate EarliPoint as a diagnostic and assessment tool for children through the age of seven and expand its body of clinical evidence to demonstrate that the technology can measure change in the same child over time.

"We are excited to partner with providers across the nation to deliver EarliPoint. We can reduce the time-consuming process of administering and documenting an objective diagnosis and assessment of autistic children, so they can receive effective treatment,” said Tom Ressemann, Chief Executive Officer of EarliTec. We believe the field of autism is quickly evolving, and we hope increased access to early diagnostic and assessment tools will allow us to deliver on our mission to ensure families have timely autism diagnosis and therapy when it matters most."

ABOUT EARLIPOINT EVALUATION

The EarliPoint Evaluation was authorized by the U.S. Food and Drug Administration in June 2022 and June 2023 (second-generation device) as an objective measurement tool that assists experts or trained clinicians in the diagnosis and assessment of autism in children aged 16 months to 30 months. Utilizing Social-Visual Engagement, the technology captures a child’s moment-by-moment looking behavior, at a rate of 120 times per second, which is otherwise imperceptible to the human eye. By measuring an individual child’s looking behavior and comparing these data to those of typically developing peers, EarliPoint provides information for early identification of autism. Through studies correlating looking behavior with clinician-based diagnostic and developmental reference standard measures, EarliPoint Severity Indices quantify levels of social disability, verbal ability, and non-verbal learning. Earlier this year, Georgia Medicaid included EarliPoint in its medical policy, which will provide coverage of the evaluation to low-income families.

ABOUT AUTISM

Autism affects approximately 1 in 36 children, one of the most common conditions impacting young children in the US and throughout the world.1 While many parents suspect symptoms of autism in the first 18 months of life, the median age of autism diagnosis in the U.S. remains four to five years of age. This delay is due to lack of access to expert clinicians and other disparities in care. The diagnosis of autism may be later still in minority and low-income communities.2

ABOUT EARLITEC DIAGNOSTICS

EarliTec Diagnostics is a medical device company making earlier identification and treatment for autism and related early childhood vulnerabilities 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 the development of biomarkers that help parents and providers understand how a child is looking and learning from the world around them. The underlying technology was developed through extensive research funded by philanthropist Bernie Marcus. The company’s initial product, the EarliPoint Evaluation, is the first objective measurement tool that clinicians can use to aid in the diagnosis and assessment of autism in children as young as 16 months. As of today, 12 EarliPoint devices are in 8 centers across 6 states in the U.S.

1. Maenner MJ, Warren Z, Williams AR, et al. Prevalence and Characteristics of Autism Spectrum Disorder Among Children Aged 8 Years – Autism and Developmental Disabilities Monitoring Network, 11 Sites, United States, 2020. MMWR Surveill Summ. 2023;72(2):1-14.
2. Constantino, J. N., Abbacchi, A. M., Saulnier, C., Klaiman, C., Mandell, D. S., Zhang, Y., Hawks, Z., Bates, J., Klin, A., Shattuck, P., Molholm, S., Fitzgerald, R., Roux, A., Lowe, J. K., & Geschwind, D. H. (2020). Timing of the Diagnosis of Autism in African American Children. Pediatrics, 146(3).
LBL2-1030 Rev. A

Contact:
Shay Smith
Health+Commerce
707-971-9779
shay@healthandcommerce.com

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