Revive Therapeutics Ltd. announced that the U.S. Food & Drug Administration ("FDA") has accepted the Company's meeting request for the Revive LC POC Lateral Flow Test Kit (the "Product") for feedback on the classification, development and regulatory submission strategy for a point-of-care in vitro diagnostic device that aids in the detection of post COVID-19 conditions. The meeting date assigned by the FDA is June 7, 2024. The Company, under its wholly-owned subsidiary Revive Diagnostics Inc., is advancing the Product as a potential blood biomarker diagnostic that characterizes long COVID.

The discovery of the biomarkers identified by a research team at Lawson, led by Dr. Douglas Fraser, was recently published in the journal, Molecular Medicine. Currently, there is no FDA-approved clinical diagnosis of long COVID and it is estimated to occur in at least 10% of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections. More than 200 symptoms have been identified with impacts on multiple organ systems2 -- including fatigue, brain fog, difficulty breathing, and cardiovascular symptoms ranging from chest pain and arrhythmias to sudden cardiac death -- but it remains a diagnosis of exclusion with an unknown biological basis3.

The Company entered into a license agreement with Lawson Health Research Institute for the worldwide exclusive rights to the intellectual property of novel blood biomarkers that characterize long COVID. The intellectual property includes PCT/CA2023/050145 entitled " Blood Biomarkers in Long-COVID19; PCT/CA20 23/051292 entitled "Biomarkers in Long- COVID19; and US Provisional Patent Application No. 63/433,425 entitled "Diagnosis and Treatment of Long-COVID".