Revive Therapeutics Announces FDA Acceptance of Meeting Request for Long COVID Diagnostic Product

TORONTO, April 18, 2024 (GLOBE NEWSWIRE) — Revive Therapeutics Ltd. (“Revive” or the “Company”) (OTCQB: RVVTF) (CSE: RVV) (FRANKFURT: 31R), a specialty life sciences company focused on the research and development of therapeutics and diagnostics for infectious diseases, medical countermeasures, and rare disorders, announced today 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 Medicine¹.

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/CA2023/051292 entitled “Biomarkers in Long-COVID19”; and US Provisional Patent Application No. 63/433,425 entitled “Diagnosis and Treatment of Long-COVID”.

About Revive Therapeutics Ltd.

Revive Therapeutics is a life sciences company focused on the research and development of therapeutics and diagnostics for infectious diseases, medical countermeasures, and rare disorders. Revive prioritizes its drug development efforts to take advantage of several regulatory incentives awarded by the FDA, such as Emergency Use Authorization, Orphan Drug, Fast Track, and Breakthrough Therapy designations. Currently, the Company is exploring the use of Bucillamine for the potential treatment of nerve agent exposure and long COVID. Revive is also advancing the development of Psilocybin-based therapeutics through various programs. For more information, visit www.ReviveThera.com.

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