Cognoa is on track for U.S. commercialization of Canvas Dx in 2023 as the first FDA authorized diagnostic device for early and equitable diagnosis of autism in young children
[Palo Alto, Calif. – November 14, 2022] – Cognoa, a pediatric behavioral health company, today announced the appointment of Dr. Sharief Taraman as Chief Executive Officer. Dr. Taraman previously served as Cognoa’s Chief Medical Officer and brings nearly two decades of clinical specialization in neurodevelopmental conditions, clinical informatics, and business acumen.
“I am excited and honored to be tasked with leading the company at this significant stage as we gear up for commercialization of our first product,” said Dr. Sharief Taraman, CEO of Cognoa. “The medical community knows unequivocally that early diagnosis of children with behavioral conditions is in the child’s and family’s best interest, but pediatricians and specialists need support. Canvas Dx serves precisely this purpose, helping providers to diagnose or rule out autism in more children sooner. Alongside Cognoa’s incredible team and supportive stakeholders, I look forward to furthering our vision that children of every gender, race, and socio-economic background can access diagnosis and care for behavioral conditions efficiently and early.”
Having joined Cognoa in 2017, Dr. Taraman served as the company’s Chief Medical Officer, leading clinical evidence generation and regulatory milestones of Canvas Dx and those resulting in FDA Breakthrough Device Designation of Cognoa’s autism digital therapeutic. Dr. Taraman brings the strategic vision and exceptional ability to accelerate Cognoa’s development of its extensible AI platform and product pipeline targeting multiple behavioral health conditions including autism, speech and language, ADHD, and childhood anxiety.
Dr. Taraman is dual board-certified in Neurology with special qualifications in Child Neurology from the American Board of Psychiatry and Neurology and Clinical Informatics and from the American Board of Preventive Medicine. Taraman brings a wealth of leadership experience as President of the American Academy of Pediatrics-Orange County Chapter (AAP-OC), Board Member of AAP-California, and advisor to the International Society for Pediatric Innovation. He also served as Division Chief of Pediatric Neurology for Children’s Health of Orange County (CHOC) and is an Associate Clinical Professor at the University of California-Irvine School of Medicine and an Affiliate Professor at the Chapman University Dale E. and Sarah Ann Fowler School of Engineering. In addition to his clinical leadership, Taraman is a pioneer of intelligence-based healthcare innovations in practice, development, and research, serving on the founding leadership team of Mi4, the Sharon Disney Lund Medical Intelligence, Information, Investigation and Innovation Institute.
“Sharief’s tenure, clinical expertise, and commitment to Cognoa is unmatched. I am excited to continue partnering with him and the team as we develop highly accurate, expedient approaches to help overcome the barriers to early diagnosis and care for children and their families, equitably and with great trust,” said Dr. Dennis Wall, Founder of Cognoa and Stanford Professor of Pediatrics and Biomedical Data Science. “Together with Sharief, we have built our first device based on multidimensional behavioral data, backed by groundbreaking AI. The power of AI-based devices is that they can be fortified by ever-expanding diverse data, and that inherently means they can always get smarter and, importantly, more diversity aware.”
To date, Cognoa has raised cumulative funding of $127 Million, led by primary investor Morningside, to support groundbreaking research and milestones including FDA De Novo marketing authorization of Canvas Dx. With real-world evidence studies and pilot programs, Cognoa is expanding patient/provider support in advance of U.S. commercialization of Canvas Dx in 2023.
Cognoa’s novel AI-based Software as a Medical Device, Canvas Dx, is the first FDA authorized diagnostic device intended to give more healthcare providers the ability to diagnose or rule out autism in children ages 18 to 72 months, with the goal of accelerating time to diagnosis and initiation of appropriate care. Canvas Dx offers a remote, data-driven approach to help identify and act early on developmental concerns in primary care, alleviating wait times for specialists and streamlining what is currently an arduous journey for families seeking answers.
About the Delay in Diagnosis of Autism Spectrum Disorder (ASD)
In the U.S., as many as 25% of children are at risk for a developmental delay, and autism is estimated to affect 1 in 44 children. Autism can be reliably diagnosed in children as young as 18 months, yet the average age of diagnosis has remained stagnant for decades at over 4 years of age. Non-white children, females, and those from rural areas or disadvantaged socio-economic backgrounds are often diagnosed even later or missed altogether. Research shows that early interventions, particularly before the age of 3, during a critical early neurodevelopmental period can improve lifelong outcomes for children living with autism. All-cause medical costs are approximately double for children who experience a longer time to diagnosis compared with a shorter time to diagnosis.
Cognoa is a pediatric behavioral health company developing AI-based technologies to enable early and equitable diagnosis and care for children living with developmental and behavioral health conditions. Cognoa’s lead product, Canvas Dx, is the first FDA authorized diagnostic device for autism. Its multidimensional, algorithm-based technology supports healthcare providers’ early, accurate diagnosis of autism and can be used in the primary care and home settings. Cognoa’s IP portfolio covers a broad pipeline of diagnostic and therapeutic products for autism, speech and language, ADHD, and childhood anxiety. For more information, visit https://www.Cognoa.com/.
Canvas Dx Indication for Use
Canvas Dx is intended for use by healthcare providers as an aid in the diagnosis of autism spectrum disorder (ASD) for patients ages 18 months through 72 months who are at risk for developmental delay based on concerns of a parent, caregiver, or healthcare provider. The device is not intended for use as a stand-alone diagnostic device but as an adjunct to the diagnostic process. The device is for prescription use only. For full indications for use, precautions, warnings, and contraindications, visit www.CanvasDx.com.
Terri Shapiro (on behalf of Cognoa)
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