BeVigilant OraFusion System
Aid in early detection of oral cancer
Pivotal TrialActive
Key Facts
Indication
Aid in early detection of oral cancer
Phase
Pivotal Trial
Status
Active
Company
About Vigilant Biosciences
Vigilant Biosciences is a private, commercial-stage diagnostics company pioneering a novel point-of-care test for the early detection of oral cancer. Its flagship product, the BeVigilant OraFusion System, utilizes patented biomarker technology to provide real-time screening in dental settings. The company has achieved significant regulatory milestones, including FDA Breakthrough Device Designation and IVDR approval for international expansion, and is now preparing for a pivotal US clinical trial to support FDA marketing authorization. Vigilant aims to address a critical unmet need in oncology by shifting diagnosis to earlier stages, where survival rates are significantly higher.
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