PainChek Limited announced that the PainChek Infant Face-Only clinical study to support CE Mark and TGA regulatory clearance has been successfully completed with findings supporting the use of PainChek Infant for procedural pain assessment with infants. A publication detailing the findings of the study has been written and submitted to a scientific journal for peer review. PainChek is on schedule for Australian (TGA) and European (CE Mark) regulatory clearance of the PainChek® Infant product in Second Quarter calendar 2021 followed by market launch in these territories. The clinical study results will support these market launches. The PainChek Infant Face-Only study was developed to test the feasibility of using PainChek® Infant's face domain alone as an indicator of pain, and evaluate it using video recordings of infants undergoing painful procedures. The study, which received ethics approval from Curtin University, involved PainChek infant face domain scores being compared with assessments conducted using the Revised Neonatal Facial Coding System (NFCS-R) and the Observer Visual Analogue Scale (ObsVAS). Both NFCS-R and ObsVAS are well known and validated scales used in assessing procedural pain in infants, such as vaccinations, finger and heel pricks, dressing changes or more invasive procedures such as biopsies. Assessment of procedural pain occurs in various settings, from hospitals to home care environments. Using the face only automatic assessment, PainChek Infant demonstrated effectiveness in procedural pain assessment, with comparison against the NFCS-R and ObsVAS demonstrating the psychometric properties of the technology i.e. validity, reliability and internal consistency. The findings showed that PainChek Infant (Face Only) has excellent correlation with NFCS-R and ObsVAS, and detailed results of the study will be made available following the peer-review and publication in a scientific journal. PainChek continues with next steps to broaden the clinical applications of PainChek Infant, including research at the Royal Children's Hospital (RCH) in Melbourne, which was put on hold due to COVID-19.