PainChek Ltd. (‘PainChek’ or ‘the Company’) announced it has received the necessary regulatory clearances including the CE Mark and UK MHRA that allow for sales and marketing of its PainChek Infant offering in Australia, Europe, UK, Canada, Singapore and New Zealand. The regulatory clearances follow completion of the PainChek's Infant Face-Only study, which demonstrated positive findings and is being peer-reviewed for publication. Findings from the study support the clinical indication for procedural pain assessment and PainChek infant is now cleared for use with infants aged between 1 month to 12 months. PainChek will now progress with launch plans for PainChek infant in these markets and will pursue opportunities in the key Hospital and Home Care markets, with potential users including children's hospitals, post-natal wards, parents and other healthcare professionals. With 400 million pre-verbal children¹ in the world, of which it is estimated 100 million are born to first time parents, PainChek Infant is now able to access a very large new market opportunity. The Company will also continue to expand the PainChek clinical applications and broaden the age ranges for Children's pain assessment through additional research and clinical studies including the existing study at the Royal Children's Hospital (RCH) in Melbourne. Existing clinical paper-based tools to assess pain for pre-verbal children, such as the FLACC2, have been available for some time, however they are rarely used in clinical practice with clinicians and nurses often relying on clinical observations to assess pain of which the infant's facial expressions are the most critical. High levels of exposure to painful face expressions can lead to observer bias, with some healthcare professionals showing an exaggerated underestimation of pain3. PainChek Infant's automated facial analysis addresses this problem. 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 to evaluate it using video recordings of infants undergoing painful procedures. The study 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. Findings from the study supported thevalidity and reliability of PainChek Infant for procedural pain assessment. Procedural pain represents a significant problem as it can have both short-term and long-term negative consequences on children's health if not managed effectively.