22.8.2025 | Talouselämä
Marginum 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® 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.
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 HIVEN® device to receive EU marketing authorisation in the fall of 2025.
Based on the number of cancer surgeries globally, the company estimates the total addressable market to be more than EUR 2 billion annually. HIVEN® device sales will be launched in the Nordic countries with a distribution partner to achieve million-euro sales in the coming years.
“This funding is a critical step toward bringing HIVEN® to surgeons and patients across Europe and the United States. It enables us to pursue FDA clearance and expand our reach to new areas where precise cancer surgery tools are urgently needed. We are responding to an unmet clinical need and aim to make aspirate tissue monitoring a global standard in oncological surgery”, says Marginum CEO Samu Lehtonen MD.
By 2030, the incidence of glial cell line tumours is expected to increase by 40%. Gliomas alone account for approximately 160,000 cases worldwide each year, and incomplete tumour removal leads to up to 70,000 reoperations annually. Fluorescence-guided surgery is also becoming more common in several different types of cancer. The FDA is currently reviewing dozens of new fluorescent drugs. 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.
“Marginum is pioneering a technology that could reshape cancer surgery worldwide. We’re investing not only in a device, but in a new way of helping surgeons make better decisions through real-time data. We believe it has the potential to improve how cancer is treated, and we’re proud to support a team with such a meaningful mission”, says Noora Tuikka, CEO at Nostetta Ventures.
The capital injection will enable Marginum to seek FDA clearance for the HIVEN® aspirate tissue monitoring device and rapidly expand into new European markets. The funding will also support strategic hiring, international expansion and continued investment in research and development. The company is dedicated to improving patient safety and surgical performance without compromising the pre-existing workflows.
Samu Lehtonen
CEO, Marginum
samu.lehtonen@marginum.com
+358 40 579 7890
Marginum is a medical technology company developing fluorescence-based tissue detection systems. The Company’s data-driven solutions enable safe and efficient monitoring of tumour tissues during cancer surgery without compromising pre-existent surgical workflows. The products are derived from state-of-the-art research to improve surgical performance and cost-effectiveness. Marginum’s multidisciplinary team collaborates closely with academic, clinical and industrial experts to ensure its technological solutions’ seamless clinical compatibility. www.marginum.com
Nostetta Ventures manages the North Savo Startup Fund, which makes venture capital investments in early-stage growth companies mainly in the North Savo region. Nostetta Ventures enables and accelerates the emergence of international growth companies and creates a positive momentum for the region's economy. www.nostettaventures.com
Published in:
30.3.2026 | MARGINUM NEWS
Marginum launches a U.S. clinical study with the HIVEN® device at the University of Illinois Hospital & Clinics (UI Health) in Chicago.
19.3.2026 | Marginum News
ALMEDA, a Prague-based medical equipment distributor, has partnered with Marginum to distribute its HIVEN® device in the Czech Republic and Slovakia.
26.2.2026 | Neuro-Oncology Advances
A first-in-human study shows that HIVEN®-based aspirate tissue monitoring provides nearly 5 times more fluorescence information than visual guidance alone.
17.12.2025 | THE FINNISH MEDICAL FOUNDATION
CEO Samu Lehtonen has been nominated for the prestigious Pohjola Medical Innovation Award in recognition of the Marginum team’s scientific contributions.
3.11.2025 | BUSINESS FINLAND
Marginum has been selected for the prestigious Young Innovative Companies (YIC) program, a recognition reserved for Finland’s most promising startups.
20.10.2025 | MARGINUM NEWS
Marginum has completed the HIVEN® usability assessment at the University of Illinois College of Medicine Surgical Innovation and Training Laboratory.