The startup company Marginum operating in Kuopio has developed HIVEN®, a fluorescence-based tissue monitoring device, to enable safe and efficient brain tumour detection. The company secured €2.5 million in Pre-Series A funding to gain U.S. Food and Drug Administration (FDA) clearance for its flagship HIVEN® device and accelerate its international launch.
The HIVEN system has already been tested in clinical use at Oslo, Tampere and Kuopio University Hospitals and has shown promising results. The tissue recognition method is based on the findings of the University of Eastern Finland’s research group led by docent Antti-Pekka Elomaa, a consultant neurosurgeon. The company expects the device to receive EU marketing authorisation in the fall of 2025.
The device assists surgeons in detecting fluorescent tumour cells during surgery. The device is attached to a surgical suction tube and provides near-instant auditory feedback when tumour cells are found in the removed tissue. A special fluorescent dye is used to highlight the cancerous cells. Unlike traditional methods, HIVEN enables the detection of fluorescence while standard surgical theatre lighting is used, which aims to help surgeons to remove tumours more completely and safely.
“This funding is a critical step toward bringing HIVEN to surgeons and patients across Europe and the United States”, says Marginum CEO Samu Lehtonen, a medical doctor trained at the University of Eastern Finland.
The company estimates that the method could be used in the future not only for brain tumours, but also for ovarian, bladder and liver cancers.
The €2.5 million Pre-Series A funding round was led by Nostetta Ventures, with continued support from existing investors Redstone and Almaral. New participants included Lynx Financial, a healthcare-focused fund, and a group of private investors with medical backgrounds. Business Finland provided important support on the round.