Marginum Launches U.S. Clinical Trial with First Patient Treated

Chicago, United States, 30 March 2026—Marginum Ltd, a Finnish medical technology company specialising in fluorescence-based tissue monitoring systems, announces the launch of a clinical trial for its flagship HIVEN® device at the University of Illinois Hospital & Clinics.

The University of Illinois Hospital & Clinics (UI Health) is a major academic medical centre in Chicago, serving as the clinical arm of the University of Illinois Chicago. UI Health is recognised for its strong expertise in neurosurgery and clinical research, providing an advanced environment for conducting investigator-led clinical trials and introducing innovative medical technologies into patient care.
 
The first patient has now been successfully recruited into the clinical trial at UI Health. This milestone marks an important step in the U.S. clinical evaluation of the HIVEN® device in a real-world hospital setting. In close collaboration with investigators from UI Health, the trial will assess the device’s performance and safety in supporting surgical decision-making in a clinical setting.

HIVEN® is a novel intraoperative margin assessment device that aims to provide near real-time feedback to support surgeons in achieving a safer, more complete tumour resection. The device is being evaluated for its potential to provide insight into tumour margin status during surgery. HIVEN® is designed to detect fluorescence from aspirated cancerous tissue during surgery without disrupting the standard workflow.

“5-ALA is an oral medication that accumulates in malignant brain tumour cells, labelling them with fluorescence at the time of surgery. This clinical study is evaluating a device designed to detect tissues fluorescence in real time as tumour fragments are removed. The goal of of the study is to assess the feasibility and performance of this technology in supporting surgical decision-making in patients with brain tumours,” says Francesco Pucci MD, neurosurgeon at UI Health. 

Marginum aims for the U.S. market

In Autumn 2025, Marginum obtained a positive decision from the University of Illinois Chicago’s Institutional Review Board (IRB) to begin the investigational clinical use of HIVEN® in the U.S. The clinical trial (NCT07111182) on intraoperative fluorescence-guided aspirate tissue monitoring (ATM 5-ALA) was launched in collaboration with the University of Illinois Hospital & Clinics (UI Health) Neurosurgery team.

“The initiation of this clinical trial represents an important step in the evaluation of the HIVEN® device in the United States,” comments Tuomas Säteri MD, Clinical Trial Physician at Marginum.

Disclaimer:
The HIVEN® device is an investigational device in the United States and is being evaluated as part of an IRB-approved clinical study. Its safety and effectiveness have not been established for general use.

Additional information:

Samu Lehtonen
CEO, Marginum
samu.lehtonen@marginum.com
+358 40 579 7890

Marginum is a Finnish medical technology company founded in 2020 and a leading innovator in fluorescence-guided oncological surgery, developing optical tissue monitoring systems. The CE-marked HIVEN® by Marginum enables safe and efficient monitoring of tumor tissues during cancer surgery by seamlessly integrating into existing surgical workflows. Marginum’s vision is to enable surgeons worldwide to perform safer, more precise operations and ultimately improve patient survival and quality of life. www.marginum.com