Marginum advances in U.S. Usability and Clinical Studies

Chicago, United States, 20 October 2025—Marginum Ltd, a Finnish medical technology company specialising in fluorescence-based tissue monitoring systems, announces the completion of the usability assessment for its HIVEN® device at the University of Illinois College of Medicine Surgical Innovation and Training Laboratory.

Surgical Innovation Training Laboratory (SITL) is a distinctive training and research facility renowned for its rich history and advanced laboratory features. Since its founding in 2008, it has been a trailblazer, the first facility globally to provide robotic surgery training for surgical residents. Marginum has initiated collaboration with the University of Illinois College of Medicine and the SITL. The team was excited to work together with SITL’s co-founder, Dr. Fady T. Charbel, the multi-awarded Head of Neurosurgery at the University of Illinois College of Medicine.

“Finding a venue for comprehensive testing of a new surgical technique can be challenging. We are overjoyed that SITL and the UIC Department of Neurosurgery made it such a success for us,”, comments docent Antti-Pekka Elomaa MD PhD, a consultant neurosurgeon in charge of HIVEN® clinical design.

The research at SITL explores fundamental aspects of surgical education, including motor learning, cognitive load, and skill acquisition, with the aim of improving the efficiency and effectiveness of training. SITL contributes to innovations in minimally invasive and robotic techniques that enhance procedural efficiency and patient safety.

HIVEN® is a novel intraoperative margin assessment device that aims to provide near real-time feedback to support surgeons in achieving a safer and more complete tumour resection. By equipping surgical teams with immediate insight into the tumour margin status, the device aims to improve oncologic outcomes and reduce the likelihood of reoperations. HIVEN® is designed to detect fluorescence from aspirated cancerous tissue during surgery without disrupting the standard workflow.
 
The usability testing for HIVEN® lasted several days at the SITL. The successful completion of this assessment represents a significant milestone in the clinical development of HIVEN® in the U.S. and its future role in more effective neurosurgical procedures.

IRB Approval for interventional study in U.S.

In collaboration with the University of Illinois Hospital (UIH) neurosurgeons, Marginum has also obtained a positive decision from the UIH Institutional Review Board (IRB) to begin investigational clinical use of HIVEN® in the U.S. The investigational study is planned to begin this autumn (ClinicalTrials.gov NCT07111182).

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