BlinkLab Research vs Kendamil Study

BlinkLab Uses: -Therapy evaluation for neurodevelopmental disorders -Diagnostic tool for neuropsychiatric disorders, such as autism and schizophrenia -Research device that can be used in the fields of neuroscience and psychology, to study mechanisms underlying learning and memory formation -A digital biomarker to optimize clinical outcome assessments in clinical studies -Educational tool for any individual who is interested in his/her own brain functioning Indications for Use BlinkLab is not intended for use as a stand-alone diagnostic device, rather it is meant to be used in addition to standard diagnostic practices. BlinkLab is intended to be used by healthcare providers to diagnose autism spectrum disorder (ASD) in infants and young children whose parents, caregivers, or healthcare providers are concerned they may be experiencing developmental delays.

Welcome to the Kendamil Study: The Kendamil app is a proprietary platform of ObvioHealth being used to manage a trial to study use of an investigational infant formula and how it affect infant growth and tolerance in comparison to current market formula. The Kendamil app removes the costly overhead of physical site visits and brings the trial directly to the mobile device of each subject. The result? Robust data collection, increased compliance, faster time to completion, and average cost savings of ~50% vs. traditional on-site trials. Subject Journey A subject who is identified as eligible for this study during pre-screening will be invited to download the Kendamil App via e-mail. Upon download, the participants create an account and complete the Informed Consent process. A series of screens explains the parameters of the study, including: o Privacy Policy o Data Gathering & Usage o Study Tasks & Surveys o Time Commitment o Option to Withdraw Subjects will have the opportunity to connect with a member of the study team to ask questions prior to signing the informed consent form. Intervention Period: Daily Tasks Subjects will contribute data to the study by completing questionnaires and data uploads over a 7-day baseline period and 16-week active trial period. Subjects can interact with the study team via secure chat as needed.