The trial is conducted in collaboration with the University Medical Center Groningen and is led by Principal Investigator Prof. Dr. Max Witjes. It aims to evaluate the effectiveness of FG001, a novel optical imaging agent that light up cancerous tissue to improve surgical precision in patients undergoing surgery for oral squamous cell carcinoma, a type of head and neck cancer. By improving tumor visibility, FG001 helps surgeons achieve more complete removal of the cancerous tissue while preserving healthy tissue. The trial will also explore the use of different types of surgical equipment to access FG001’ application across a variety of surgical environments.

“Initiation of this trial marks a significant milestone in our mission to enhance surgical outcomes for patients with head and neck cancer, also reflecting the strong collaboration between FluoGuide, leading surgeons, and surgical equipment partners, including Intuitive Surgical to address the challenges posed by cancerous tumors located in anatomically complex areas.” says Morten Albrechtsen, CEO of FluoGuide, “We look forward to advance FG001 through this trial and look forward to the interim data, which will be a key step forward in the development of our head and neck program for FG001.”

The trial is a single-center trial (FG001-CT-005) designed to:

• Evaluate multiple endpoints for measuring surgical completeness using FG001
• Explore the different benefits of FG001 in assisting head and neck cancer surgery
• Assess the use of different surgical equipment types

The first interim date is anticipated in the second half of 2025 and will serve as a key data trigger point. Upon completion of this phase II trial and guided by data, FluoGuide plans to initiate a multi-site registration trial as the next step toward regulatory approval and commercialization of FG001.