Lakeway, TX – Vigilant Biosciences, a leader in the development of innovative solutions for the early detection of oral cancer, is pleased to announce that the U.S. Food and Drug Administration (FDA) has aligned on clinical requirements for a pivotal multi-site trial set to take place across the United States and Europe. This groundbreaking trial will evaluate the efficacy of Vigilant Biosciences’ novel oral cancer detection technology, BeVigilant™ OraFusion™ System, in a diverse cohort of patients diagnosed with oral cancer, confirmed by specialists and oral pathologists.
Oral cancer remains a significant public health concern, with alarming statistics highlighting its impact. According to the American Cancer Society, an estimated 54,540 new cases of oral cavity and oropharyngeal cancers are expected to be diagnosed in the United States in 2024 alone. Furthermore, approximately 72% of these cases are diagnosed at a late stage, where treatment options are limited, and survival rates drastically decrease.
The rising incidence of oral cancer is a concerning trend, with the World Health Organization reporting an increase in cases worldwide. Factors contributing to this rise include tobacco use, excessive alcohol consumption, and the human papillomavirus (HPV). Vigilant Biosciences aims to address this urgent need for early detection, which is critical for improving patient outcomes and survival rates.
“With the FDA’s alignment on our clinical trial requirements, we are excited to move forward with our pivotal trial that has the potential to revolutionize the way oral cancer is detected,” said Bill Brodie, CEO of Vigilant Biosciences. “Our technology is designed to facilitate earlier diagnosis, which is essential in combating the rising incidence of late-stage oral cancer diagnoses. We are committed to providing healthcare professionals with the tools they need to improve patient care.”
The multi-site trial will engage leading medical and dental centers across the U.S. and Europe, utilizing a state-of-the-art detection platform that combines advanced imaging and biomarker analysis. This trial represents a significant step towards ensuring that oral cancer is detected at its earliest and most treatable stages.
Vigilant Biosciences is committed to advancing oral cancer detection and enhancing patient outcomes through innovation and collaboration with healthcare professionals. The company looks forward to sharing further updates as the trial progresses.
For more information, please contact:
Vigilant Biosciences, customerservice@vigilantbiosciences.com, vigilantbiosciences.com
About Vigilant Biosciences Vigilant Biosciences is committed to developing innovative solutions for early detection of oral cancer, utilizing cutting-edge technology to enhance diagnostic accuracy and improve patient outcomes. Our mission is to empower healthcare providers with the tools they need to combat oral cancer effectively.
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