Press & news

FluoGuide develops surgical solutions that is expected to reduce suffering for the patient and increases the likelihood of cure as well as reducing costs for the health care system.

New exchange: Nasdaq First North

FluoGuide is moving from Spotlight to Nasdaq First North. Shareholders are strongly encouraged to make sure they will be able to freely trade their shares in the future.

New exchange: Nasdaq First North

FluoGuide updates on recruitment in phase IIb aggressive brain cancer trial with FG001

News


February 27, 2023

FluoGuide A/S (“FluoGuide” or the “Company”) provides an update on the clinical timelines for the ongoing clinical phase IIb trial of FG001 in patients with aggressive brain cancer (high grade glioma) undergoing surgery.

Based on our latest estimate, the Company expects the last patient in the ongoing clinical trial of FG001 in patients with aggressive brain cancer to be enrolled during the summer 2023. The topline result will be presented approx. 8 weeks after last patient is enrolled. The 8 weeks are needed for the histopathologists to analyse the biopsies and the radiologists to analyse the MRI scans. The analysis of the biopsies and MRI scans is blinded and can therefore first be initiated after the last patient has been enrolled. The topline result was previously estimated to H1 2023.

The guidance for the topline results of the lung and head & neck trials remains unchanged.

For further information, please contact:

Morten Albrechtsen, CEO,
FluoGuide A/S
+45 24 25 62 66,
ma@fluoguide.com

Certified Adviser:
Svensk Kapitalmarknadsgransking AB
Phone: +46 70 755 95 51
E-mail: ca@skmg.se

About FluoGuide
FluoGuide takes precision surgery to the next level improving the outcome for cancer patients. The Company’s lead product, FG001, is designed to improve surgical precision by illuminating cancer cells intraoperatively. The improved precision enabled by FluoGuide’s products is expected to have a dual benefit – it reduces both the frequency of local recurrence post-surgery and lessens surgical sequelae. Ultimately, the improved precision will improve a patient’s chance of achieving a complete cure and will lower system-wide healthcare costs. The Company has demonstrated efficacy of F001 as well as it being well tolerated and safe in the completed proof-of-concept clinical study (phase I/IIa) in patients with aggressive brain cancer (high grade glioma) undergoing surgery. A phase IIb trial in aggressive brain cancer is ongoing to obtain valuable information to design the phase III trial. In addition, FluoGuide currently explores FG001 lung and head & neck cancer, and a trial in meningioma and low grade glioma is commencing. FluoGuide is listed on Nasdaq First North Growth Market, Stockholm under the ticker “FLUO”.

For more information on the Company, please visit www.fluoguide.com