FluoGuide A/S (Nasdaq First North Growth Market:FLUO), a Denmark-based biotech company specialising in precision cancer surgery, revealed on Tuesday that it has enrolled the first patient in its phase II clinical trial (CT-005) evaluating FG001 for use in head and neck cancer surgery.

Conducted in collaboration with the University Medical Center Groningen and led by Principal Investigator Prof. Dr. Max Witjes, the trial focuses on patients with oral squamous cell carcinoma.

FG001 is an optical imaging agent designed to illuminate cancerous tissue during surgery, enhancing tumour visibility and enabling more precise removal while preserving healthy tissue.

The single-centre study aims to assess multiple endpoints related to surgical completeness and explore FG001's performance across various surgical equipment types.

FluoGuide expects interim data from the trial in the second half of 2025, which will serve as a key milestone in evaluating the product's clinical utility.

Based on trial outcomes, the company intends to launch a multi-site registration trial to support regulatory approval and future commercialisation of FG001.