Wyoming Medicaid Becomes First State to Cover Cognoa’s Canvas Dx, Expanding Access to Early Autism Diagnosis

Cognoa Appoints Michael Butler as Board Executive Chair to Further Propel Access to First FDA Authorized Diagnostic for Autism

Having served as President of Providence for over 20 years, Mike Butler’s leadership experience expanding healthcare access is poised to drive the reimbursement and clinical adoption of Canvas Dx, Cognoa’s groundbreaking autism and child development diagnostic PALO ALTO, Calif., Sept. 10, 2024 /PRNewswire/ — Cognoa, a leading child development and behavioral health company, today announced the appointment of Mike Butler as Executive Chair of Cognoa’s Board of Directors. With more than three decades of experience in healthcare delivery, Mike Butler is renowned for his transformative leadership at Providence, one of the largest health systems in the US, where he served as President from 1998 until his retirement in 2020. Under his leadership, Providence’s annual revenue increased from $2 billion to $25 billion, and Butler was instrumental in devising a unified growth strategy that expanded Providence’s network of care throughout the western United States. His dedication to scaling healthcare delivery was crucial in driving clinical advancements, fostering innovation, and enhancing affordability. “I am honored to join Cognoa as Executive Chair and to be part of a team that is at the forefront of transforming and improving pediatric healthcare,” said Butler. “The work Cognoa is doing is nothing short of life-changing for patients and caregivers. The company’s commitment and truly innovative approach to early, accurate, and equitable diagnosis of pediatric behavioral health conditions deeply resonates with my lifelong mission to enhance healthcare delivery and accessibility for every human being. Together with the team at Cognoa, I am dedicated to addressing critical early developmental needs in clinics worldwide.” Cognoa specializes in responsible AI-driven products for pediatric behavioral health, focusing on early diagnosis and treatment of conditions like autism. Designed for remote use within primary and specialty care settings alike, Cognoa’s flagship solution, Canvas Dx, the first and only FDA authorized AI diagnostic for pediatric autism, equips healthcare professionals to act rapidly upon first developmental concern and make informed decisions for next steps, so children can begin life-changing therapies earlier. Canvas Dx is trained on a diverse dataset spanning race, gender, educational level, and socioeconomic status, ensuring an objective and equitable diagnostic experience that aims to eliminate the biases and disparities perpetuated by current standards of practice. “We are thrilled to welcome Mike Butler as Executive Chair of our Board of Directors to support our efforts to eliminate unnecessary waitlists everywhere,” said Dr. Sharief Taraman, CEO of Cognoa. “Mike’s extensive and unparalleled experience in healthcare delivery and visionary leadership are a welcome addition as we expand the reach and impact of Canvas Dx. Together, we are dedicated to ensuring that every child receives timely and effective interventions, setting the stage for a much brighter future in healthcare.” Cognoa is leading the push to provide earlier, more equitable diagnosis to children with concern for developmental delay and is being rapidly adopted by healthcare systems and clinical practices nationally and internationally. The company recently announced that Highmark has become the first commercial insurer to cover the cost of Canvas Dx for its network members. About Cognoa Cognoa innovates solutions for healthy child development. We build breakthrough products like Canvas Dx, the first and only FDA authorized autism diagnostic for children ages 1.5 to 6 years that uses responsible AI to empower doctors to quickly, accurately, and fairly diagnose developmental risk without bias. Our digital solutions are child centric and designed to find, assess, and treat developmental concerns early, within the time windows that will yield the optimal outcomes. Our proprietary “whole child” approach to AI fuels our pipeline of diagnostic and therapeutic products for autism, speech and language, ADHD, childhood anxiety, and more. For more information, visit www.cognoaprodstg.wpengine.com. Media ContactTerri Shapiro (on behalf of Cognoa)terri@headline.media+1-347-344-5316

New Study Sponsored by Cognoa Exposes Alarming Wait Times and Persistent Inequities Obstructing Early Autism Diagnosis and Early Interventions

Fierce Names Dr. Dennis Wall, Founder of Cognoa, as One of its Fierce 50 Honorees of 2023

PALO ALTO, Calif., Oct. 3, 2023 /PRNewswire/ — Cognoa, the leading child health company, today announced that Fierce Healthcare and Fierce Life Sciences have named the company’s Founder, Dr. Dennis Wall, as one of 2023’s Fierce 50 honorees. The Fierce 50 showcases 50 companies and individuals driving advancements in medicine, fostering innovation, and shaping the future of biopharma and healthcare. “The Fierce 50 special report shines a spotlight on those who are making a significant impact and driving progress in the pharmaceutical, healthcare, and biotech industries,” said Ayla Ellison, Editor-in-Chief, Fierce Life Sciences and Healthcare. “These outstanding individuals and companies exemplify excellence in their fields, and their dedication to innovation and improving lives is truly commendable. Congratulations to this year’s honorees.” Dr. Wall is an innovative scientist who has focused his career on supporting developing children and their families by inventing pioneering solutions and making them widely accessible. Dr. Wall received his PhD from University of California, Berkeley, and fellowship in Computational Genetics from Stanford. As a professor for the last 20 years at Stanford and Harvard Medical Schools, his work has focused on building novel artificial intelligence methods within digital technologies and mobile games to detect and positively impact learning differences in children. He is one of the world’s top 25 autism researchers, has published more than 200 papers and patents, and founded the company, Cognoa. “I am humbled and deeply grateful to be named a Fierce 50 honoree,” said Dr. Wall, “I wouldn’t be here without my family, without the inspiration of Becky. The growth of a child is inspiring, wild, uncharted waters all at the same time. Making sure all children have equal opportunities to thrive in their own way is what my work is all about, where all of my energy goes. Children animate and implore one to think and work outside of the box, play, imagine and create. With their inspiration in my own work, I’ve been able to use ingredients children love to build unique and powerful solutions that are inclusive and diversity aware. Ultimately, this is the path to better healthcare for kids.” Dr. Wall continues, “The one solution about which I am most excited is Canvas Dx. Until now, families have had to wait more than a year to get assessed for autism or other concerns, and even longer to get the treatments that will make the difference. Canvas Dx is the first developmental pediatric diagnostic approved by the FDA. It is at once innovative and precisely clinical. It is the only one that uses artificial intelligence to make diagnoses rapidly, objectively, fairly, and remotely so that children anywhere can get care during the ideal windows of development, before age 6. Canvas eliminates the one year wait and reduces healthcare costs by at least 20x. It is used by general physicians and specialists alike and will help at least three million U.S. children every year, starting now. I am thrilled that Fierce recognizes how truly important this work is for much needed disruption of the status quo – empowering more providers to facilitate quick, accurate, early answers and interventions for all kids.” The Fierce 50 is a constellation of the most brilliant visionaries and trailblazers, handpicked by the discerning editors of Fierce Biotech, Fierce Pharma and Fierce Healthcare. These are the movers and shakers who are pushing boundaries, defying limitations and igniting change in healthcare delivery, drug development, research and beyond. A complete list of the Fierce 50 honorees can be viewed online at www.fiercepharma.com/fierce-50. The Fierce 50 honorees will be celebrated live at an evening gala at the Edison Ballroom in New York on December 5th. For more information visit https://fierce50.fiercelifesciences.com/. About Cognoa Cognoa innovates solutions for child health. We build breakthrough products like Canvas Dx, the first and only FDA-authorized autism diagnostic that uses responsible AI to empower doctors to quickly, accurately, and fairly diagnose developmental risk without bias. Our digital solutions are child centric and designed to find and treat developmental concerns early and within the time windows that will yield the optimal outcomes. Our proprietary “whole child” approach to AI fuels our pipeline of diagnostic and therapeutic products for autism, speech and language, ADHD, childhood anxiety, and more. For more information, visit www.cognoaprodstg.wpengine.com. About Questex Questex helps people live better and longer. Questex brings people together in the markets that help people live better: travel, hospitality and wellness; the industries that help people live longer: life science and healthcare; and the technologies that enable and fuel these new experiences. We live in the experience economy – connecting our ecosystem through live events, surrounded by data insights and digital communities. We deliver experience and real results. It happens here. MEDIA CONTACTS:Linda LamDirector of Marketing, Life Sciences and Healthcarellam@questex.comTerri Shapiro (on behalf of Cognoa)terri@headline.media+1-347-344-5316

Cognoa Announces Leadership Expansion with Strategic Hires

Key appointments strengthen Cognoa’s expertise in commercial and clinical adoption PALO ALTO, Calif., June 1, 2023 /PRNewswire/ — Cognoa, a leading pediatric behavioral health company, today announced the expansion of its leadership team supporting the commercialization of Canvas Dx, the first and only FDA authorized diagnostic that gives diverse providers the ability to diagnose or rule out autism in children ages 1.5 to 6 years at risk of developmental delay. “We are excited to announce the expansion of our leadership team at Cognoa as we continue to accelerate our commercialization efforts of Canvas Dx,” said Dr. Sharief Taraman, CEO of Cognoa. “Dr. Pollard and Mr. Devennie will expand our capabilities in crucial commercial areas and further clinical adoption as we continue to focus on addressing the crisis of late diagnosis. We look forward to leveraging their expertise as we work towards our goal of enabling early, accessible, equitable diagnosis and care for young children with developmental and behavioral health conditions.” New Cognoa Leadership Team Members Jeffrey Pollard, M.D., Senior Vice President of Medical and Clinical Affairs joins Cognoa from 23andMe where he was Director of Medical Affairs, responsible for the company’s efforts to advance the integration of personal genomics into the modern healthcare system. Dr. Pollard will establish and direct Cognoa’s medical affairs team to execute the broad availability of Canvas Dx. Pollard held several leadership positions at HealthTap and ZendyHealth. He is a double board-certified physician and surgeon and holds an M.D. from Vanderbilt University and a B.S. in Health Psychology from Duke University. Brandon Devennie, Senior Vice President, Commercial Strategy, is an industry-leading executive with a proven track record of success in market access strategy. He joined Cognoa in 2021, establishing partnerships with some of the largest national and regional distributors in the U.S. and self-funded employer access channels. In this newly created role, he is responsible for further executing Cognoa’s commercialization strategy in the U.S. and global markets. Devennie has held several commercial leadership positions at Heuro Health, Tricida, and Allergan. Designed for remote use within primary and specialty care settings alike, Canvas Dx equips healthcare professionals to act rapidly upon first developmental concerns and make informed decisions for next steps, so children can begin life-changing therapies earlier. With its AI trained on diverse data across race, gender, educational level, and socioeconomic status, Canvas Dx introduces an objective, equitable diagnostic solution to remove the biases and disparities that exist and continue to grow with the current standards of practice. About CognoaCognoa is a leading pediatric behavioral health company developing AI-based diagnostic and therapeutic products for early, accessible, equitable care to create life-changing, positive outcomes for children and families. Cognoa’s Canvas Dx is the first and only FDA authorized diagnostic solution that enables rapid, remote, and data-driven developmental evaluation and diagnosis of autism in young children. Cognoa’s whole child data approach and responsible AI creates an extensible platform that supports a broad pipeline of diagnostic and therapeutic products for autism, speech and language, ADHD, and childhood anxiety. For more information, visit www.cognoaprodstg.wpengine.com. Canvas Dx Indication for UseCanvas 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, www.cognoaprodstg.wpengine.com. Investor Relations ContactJulie SeidelJulie.seidel@sternir.com+1-212-698-8684 Media ContactTerri Shapiroterri@headline.media+1-347-344-5316 SOURCE Cognoa

Cognoa and Health Transformation Alliance Partner to Provide Access to Child Health Solution Canvas Dx for Self-Insured Employers

https://www.prnewswire.com/il/news-releases/cognoa-and-health-transformation-alliance-partner-to-provide-access-to-child-health-solution-canvas-dx-for-self-insured-employers-301748831.html Nearly 60 of America’s leading employers will now be able to offer their employees with children access to Canvas Dx™, the first FDA-authorized diagnostic device for autism in young children [Palo Alto, Calif. – February 16, 2023] – Health Transformation Alliance (HTA), a cooperative of nearly 60 of America’s largest employers, has partnered with Cognoa, a pediatric behavioral health company, to offer the company’s Canvas Dx diagnostic device for autism to all HTA Member organizations and their employees. HTA will offer its member organizations – some of the most influential and significant brands in the U.S. – the opportunity to add Canvas Dx to their benefit design. This partnership comes at an ideal time when the pandemic has exacerbated long-standing gaps in pediatric behavioral and developmental healthcare. As the first FDA authorized diagnostic device of any kind for autism, the goal of Canvas Dx is to alleviate wait times for specialists and streamline the arduous journey for families seeking answers by giving more healthcare providers the ability to diagnose or rule out autism in children ages 18 to 72 months who are at risk for developmental delay. “The pediatric behavioral and mental health crisis continues to grow, and health equity issues create even greater barriers for some families,” said Mallory Huff, HTA’s Vice President of Strategic Product Development. “Leading employers recognize the struggles and multi-year delays families face when concerned for their child’s development and searching for answers from healthcare providers. There are significant clinical and financial costs for these delays, impacting both families and employers. With Canvas Dx, parents have a clear path to answers and are empowered instead of burdened with stress and uncertainty.” AI-powered Canvas Dx enables mobile, accurate, and efficient action on developmental concerns during early childhood within primary care, thereby accelerating time to diagnosis and initiation of appropriate care. With this cutting-edge medical benefit, employers can curb the costly impacts of the child healthcare crisis for families and the workplace, and their employees can benefit from timely care of their developing children. “How we identify developmental and behavioral conditions in children has not improved in decades, even as we are seeing greater diagnostic and care shortages,” said Dr. Sharief Taraman, CEO of Cognoa. “This partnership marks a significant milestone for Cognoa as we now have a direct channel that encourages employers to act now to support their employees’ ability to care for their children, and for themselves. We are proud to partner with HTA and their Member organizations who are committed to transforming early childhood healthcare through innovative and accessible solutions that impact the lifetime trajectory of children and the whole family.” 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 three, during a critical early neurodevelopmental period, can improve lifelong outcomes for children. All-cause medical costs are approximately double for children who experience a longer time to diagnosis compared with a shorter time to diagnosis. About Cognoa 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 portfolio covers a broad pipeline of diagnostic and therapeutic products for autism, speech and language, ADHD, and childhood anxiety. For more information, visit www.cognoaprodstg.wpengine.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. About Health Transformation Alliance The Health Transformation Alliance (HTA) is a cooperative of nearly 60 of America’s leading employers that have come together to fix our broken healthcare system. With responsibility for more than 4 million lives in the United States and a collective annual health care spend of $27 billion, the member companies of the HTA have combined their resources, knowledge, and experience to transform the way healthcare is delivered. To that end, the HTA has developed value-driven solutions in data and analytics, pharmacy, medical and consumer engagement specifically designed to improve patient care and economic value. To learn more, visit www.htahealth.com. Media Contacts Terri Shapiro (on behalf of Cognoa) terri@headline.media +1 347 344 5316   Annie Zdrojewski (on behalf of HTA) Annie.Zdrojewski@berkeleypr.com +1 720 299 8476

Cognoa to Participate in BTIG Digital Health Forum 

https://www.prnewswire.com/il/news-releases/cognoa-to-participate-in-btig-digital-health-forum-301680076.html [Palo Alto, Calif. – November 16, 2022] – Cognoa, a leading pediatric behavioral health company, today announced that Sharief Taraman, MD, DABPN, DABPM, FAAP, Chief Executive Officer of Cognoa, will participate in the opening analyst-led fireside chat at the BTIG Digital Health Forum on Monday, November 21, 2022 at 7 a.m. ET / 4 a.m. PT. Cognoa management will be available for virtual one-on-one meetings with investors during the conference.  BTIG hosted events are intended for prospective and existing BTIG clients only. To listen to the live event and to schedule a one-on-one meeting, please contact your BTIG representative or email info@btig.com.  About Cognoa 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 strong IP portfolio covers a broad pipeline of early-stage diagnostic devices and complementary digital therapeutic programs for autism, speech & language, ADHD, and childhood anxiety. For more information, visit www.Cognoa.com. Media Contact  Terri Shapiro (on behalf of Cognoa) terri@headline.media +1 347 344 5316 https://www.prnewswire.com/il/news-releases/cognoa-to-participate-in-btig-digital-health-forum-301680076.html

Cognoa Appoints Pediatric Neurologist and AI in Healthcare Pioneer Dr. Sharief Taraman as CEO to Spearhead the Next Stage of the Company’s Growth

https://www.prnewswire.com/news-releases/cognoa-appoints-pediatric-neurologist-and-ai-in-healthcare-pioneer-dr-sharief-taraman-as-ceo-to-spearhead-the-next-stage-of-the-companys-growth-301677002.html 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. About Cognoa 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. Media Contact  Terri Shapiro (on behalf of Cognoa) terri@headline.media +1 347 344 5316   https://www.prnewswire.com/news-releases/cognoa-appoints-pediatric-neurologist-and-ai-in-healthcare-pioneer-dr-sharief-taraman-as-ceo-to-spearhead-the-next-stage-of-the-companys-growth-301677002.html  

Cognoa Announces Poster Presentations at the 2022 American Academy of Pediatrics (AAP) National Conference and Exhibition

https://www.prnewswire.com/news-releases/cognoa-announces-poster-presentations-at-the-2022-american-academy-of-pediatrics-aap-national-conference-and-exhibition-301642639.html [Palo Alto, Calif. – October 6, 2022] – Cognoa, a pediatric behavioral health company, today announced that the Company will be participating in the 2022 American Academy of Pediatrics (AAP) National Conference and Exhibition, taking place October 7 – 11, 2022, at the Anaheim Convention Center in Anaheim, California, and online.    The Company will present two scientific posters. Details of the sessions include:   Title: Exploring the Real World Performance of an Artificial Intelligence-based Diagnosis Aid for Autism: An Aggregate and De-identified Analysis of Early Canvas Dx Prescription and Output Data Post-market Authorization Program: Section on Advances in Therapeutics and Technology Presenting Author: Sharief Taraman, MD, FAAP, Chief Medical Officer, Cognoa; Associate Professor, Pediatric Neurology/Clinical Informatics, University of California-Irvine, Children’s Health of Orange County Location: Anaheim Convention Center, Hall A, Board # 009 Date and Time: Monday, October 10, 2022, 1:30 PM – 2:30 PM PDT Key Findings: An analysis of early commercial prescription and output data for Canvas Dx in real world settings finds: On average, children in the analysis received a positive for autism device output 13.2 months earlier than the current average age of autism diagnosis in the U.S. (4 years and 2 months).  Prescribers in 13 states have used the device, including many who work in primary care settings. Analysis of clinical deployment of Canvas Dx suggests device use is feasible in primary care and could expand autism diagnostic capacity. There was no evidence of device performance inconsistency across patients’ sex. While further analysis powered for statistical inference is needed to better characterize equity in performance, this is a promising finding given existing gender biases in autism diagnosis. Today, females are less often diagnosed, misdiagnosed more often, and when diagnosed, are diagnosed later on average than males.   Title: Time to Autism Diagnosis and Healthcare Utilization and Costs: A Retrospective Commercial Claims Analysis Program: Council on Clinical Information Technology Presenting Author: Carmela Salomon, PhD, RN, Head of Scientific Communications, Cognoa Location: Anaheim Convention Center, Hall A, Board # 068 Date and Time: Sunday, October 9, 2022, 4:00 PM – 5:00 PM PDT Key Findings: In the year prior to receiving an autism diagnosis, children who had a longer time to diagnosis experienced a greater number of both all-cause and autism-related health care visits compared with children who had a shorter time to diagnosis. The mean all-cause medical cost per child was approximately two times higher for those with longer time to diagnosis.   Poster presentations will be on display for one day in their designated poster hall. Authors will be available to discuss the posters during the designated times. The poster hall Hall A at the Anaheim Convention Center will be open October 8 – 10, 10 AM to 6 PM PDT. Cognoa representatives will also be available at booth 2401in the exhibit hall October 8, 12:15 PM – 4:00 PM, October 9, 10:00 AM – 4:00 PM, and October 10, 10:00 AM – 12:00 PM. For more information about 2022 AAP, visit https://aapexperience.org/.   About Cognoa 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 speech and language, ADHD and childhood anxiety. For more information, visit https://www.cognoaprodstg.wpengine.com/.   Media Contact  Terri Shapiro (on behalf of Cognoa) terri@headline.media +1 347 344 5316

ECHO Autism Communities Collaborate with Cognoa to Study Real-World Application of Canvas Dx 

https://www.prnewswire.com/news-releases/echo-autism-communities-collaborate-with-cognoa-to-study-real-world-application-of-canvas-dx-301558915.html[Palo Alto, Calif. – June 1, 2022] – Cognoa, a pediatric behavioral health company, is announcing the initiation of a real-world evidence study of its novel AI-based software as a medical device, Canvas Dx, in collaboration with the University of Missouri (MU) ECHO Autism Communities Research Team. ECHO Autism Communities is a telementoring program that increases participating clinicians’ expertise in the diagnosis and care of autism spectrum disorder (ASD). The primary objective of the study is to assess the time from initial concern to diagnostic determination utilizing Canvas Dx within the ECHO Autism Communities Primary Care diagnostic model for children at risk of developmental delay. “We are excited to incorporate Cognoa’s Canvas Dx within our existing diagnostic model in hopes of expanding primary care physicians’ tools to reliably identify and diagnose children with autism.” said Kristin Sohl, M.D., Executive Director of ECHO Autism Communities and a pediatrician who specializes in autism at University of Missouri Health Care. “We are continuously exploring how innovations like Canvas Dx may help streamline the pathway to care, make more efficient use of specialty centers, and drive down wait times in a way that overcomes geographic and socio-economic barriers. These are the driving motivations of our collaboration with Cognoa in this real-world study.” Canvas Dx is the first FDA authorized diagnosis aid intended to assist primary care physicians to diagnose or rule out autism in children ages 18 to 72 months, with the goal of accelerating time to diagnosis to potentially enable families to begin appropriate interventions during a critical neurodevelopmental window. Canvas Dx offers an efficient, data-driven approach to help physicians act on early developmental concerns. The prospective, observational real-world study, conducted by the University of Missouri (MU) ECHO Autism Communities Research Team, is the first to evaluate real-world effectiveness of Canvas Dx as part of a primary care diagnostic pathway. The study will enlist up to 15 MU ECHO Autism Community trained clinicians in both rural and suburban areas in Missouri and up to 100 children at risk of ASD or developmental delay, aged 18-72 months. The study is listed on clinicaltrials.gov. “We are excited to collaborate with the ECHO Autism team to evaluate how Canvas Dx can support physicians to diagnose or rule out autism in the primary care setting,” said Sharief Taraman, MD, Chief Medical Officer of Cognoa. “The demand for diagnosing children at risk of developmental delay far exceeds the ability of prevalent processes to provide timely diagnosis. ECHO Autism is an exemplary model to increase the capacity of care for children with neurodevelopmental conditions. Through this study, we hope to learn that the combination of Cognoa’s accurate and efficient technology, along with improvements in clinician knowledge, clinical expertise and longitudinal care that is the basis of ECHO Autism, can improve the quality of care for children and families.” About 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 ASD is estimated to affect 1 in 44 children. Autism can be reliably diagnosed in children as young as 18 months, yet the average 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 with ASD. To learn more, visit www.knowautismearly.com. Important Information Canvas Dx Indications for Use Canvas Dx is intended for use by healthcare providers as an aid in the diagnosis of 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 diagnosis device but as an adjunct to a primary care provider’s clinical judgment. The device is for prescription use only (Rx only). Contraindications There are no contraindications to using Canvas Dx. Precautions, Warnings The Device is intended for use by healthcare professionals trained and qualified to interpret the results of a behavioral assessment examination and to diagnose ASD.  The Device is intended for use in conjunction with patient history, clinical observations, and other clinical evidence the healthcare provider determines are necessary before making clinical decisions. For instance, additional standardized testing may be sought to confirm the Device output, especially when the Device result is not Positive or Negative for ASD.  Canvas Dx is intended for patients with caregivers who have functional English capability (8th grade reading level or above) and have access to a compatible smartphone with an internet connection in the home environment. The Device may give unreliable results if used in patients with other conditions that would have excluded them from the clinical study. Among those conditions are the following: Suspected auditory or visual hallucinations or with prior diagnosis of childhood onset schizophrenia Known deafness or blindness Known physical impairment affecting their ability to use their hands Major dysmorphic features or prenatal exposure to teratogens such as fetal alcohol syndrome History or diagnosis of genetic conditions (such as Rett syndrome or Fragile X) Microcephaly History or prior diagnosis of epilepsy or seizures History of or suspected neglect History of brain defect injury or insult requiring interventions such as surgery or chronic medication The Device evaluation should be completed within 60 days of the time it is prescribed because neurodevelopmental milestones change rapidly in the indicated age group. About Cognoa Cognoa is a pediatric behavioral health company developing digital diagnostic and therapeutic products with the goals of enabling earlier and more equitable access to care and improving the lives and outcomes of children and families living with behavioral conditions. Cognoa’s products are intended to be routinely prescribed by providers and covered by insurers. For more information, visit https://www.cognoaprodstg.wpengine.com/. About Extension for Community Healthcare Outcomes (ECHO) Autism Communities  Extension for Community Healthcare Outcomes (ECHO) Autism Communities at the