LAKEWAY, Texas (April 27, 2023) — Vigilant Biosciences®, Inc. (“Vigilant”), a leading innovator and developer of solutions that aid in the early detection of oral cancer, is proud to announce receipt of Breakthrough Device Designation from the Food and Drug Administration (FDA) for its point-of-care test to aid in the early detection of oral cancer.
The BeVigilant™ OraFusion™ Test is the first of its kind to provide a tool for oral cancer detection by determining the presence of certain biomarkers combined with artificial intelligence software for clinical risk factors. Early detection, as defined by detection in either Stage 1 or Stage 2, can lead to significantly improved outcomes with survival rates as high as 90%. The current oral cancer survival rate is only 50% due to delayed intervention.
“This Breakthrough Designation is a critical milestone in the review process of what we believe to be a lifesaving technology,” said Bill Brodie, CEO of Vigilant Biosciences®. “Ongoing clinical results indicate significant benefits offered to patients and allow us to continue our mission of providing a world-class early detection solution for the presence of oral cancer.”
The Breakthrough Devices Program was created to provide patients with more timely access to innovative medical devices by expediting their development, assessment, and review while preserving the statutory standards for premarket approval, 510(k) clearance, and DeNovo marketing authorization, according to the FDA.
About Vigilant Biosciences®, Inc.
Vigilant Biosciences® is a leading innovator and developer of solutions that aid clinicians in the early detection of oral cancer. Vigilant’s BeVigilant™ product line includes point-of-care testing that is simple, accurate and cost-effective, and empowers healthcare practitioners to improve lives through earlier intervention. The BeVigilant™ OraFusion™ System is not available for sale in the U.S.
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