Rachel Klemovitch, Assistant Editor04.03.24
Medical device company EarliTec Diagnostics raised $21.5 million in a Series B financing round that was led by Nexus Neuro Tech Ventures and Venture Investors Health Fund. Funding will contribute to commercialization efforts and clinical research for the first-in-kind EarliPoint Evaluation. EarliPoint is the first personalized, quantifiable, and objective device that assists in the diagnosis and assessment of autism in children 16-30 months old.
In 2022 EarliPoint Evaluation earned FDA 510(k) clearance and in 2023 a second-generation device was authorized as an objective measurement tool to assist experts and trained clinicians. Earlier this year, Georgia Medicaid incorporated EarliPoint in its medical policy, providing coverage of the evaluation for low-income families.
"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 EarliTec CEO, Tom Ressemann. "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."
An EarliPoint evaluation assesses the level of function on the core characteristics of autism: social disability, verbal ability, and non-verbal learning. During an evaluation, children watch videos of social interactions on a portable tablet and an embedded biomarker tracks how the child focuses on the scenes.
The technology captures a child’s behavior moment-by-moment at a rate of 120 times per second. EarliPoint Severity Indices quantify levels of social disability, verbal ability, and non-verbal learning through studies that correlate behavior with clinician-based diagnosis and developmental reference standards.
"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 and 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 funding will aid in commercialization and in completing studies to evaluate EarliPoint as a diagnostic and assessment tool for children through the age of seven. EarliTech also hopes to gain more clinical evidence demonstrating EarliPoint technology can measure change in the same child over time.
"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.
"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.
In 2022 EarliPoint Evaluation earned FDA 510(k) clearance and in 2023 a second-generation device was authorized as an objective measurement tool to assist experts and trained clinicians. Earlier this year, Georgia Medicaid incorporated EarliPoint in its medical policy, providing coverage of the evaluation for low-income families.
"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 EarliTec CEO, Tom Ressemann. "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."
An EarliPoint evaluation assesses the level of function on the core characteristics of autism: social disability, verbal ability, and non-verbal learning. During an evaluation, children watch videos of social interactions on a portable tablet and an embedded biomarker tracks how the child focuses on the scenes.
The technology captures a child’s behavior moment-by-moment at a rate of 120 times per second. EarliPoint Severity Indices quantify levels of social disability, verbal ability, and non-verbal learning through studies that correlate behavior with clinician-based diagnosis and developmental reference standards.
"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 and 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 funding will aid in commercialization and in completing studies to evaluate EarliPoint as a diagnostic and assessment tool for children through the age of seven. EarliTech also hopes to gain more clinical evidence demonstrating EarliPoint technology can measure change in the same child over time.
"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.
"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.