Marginum Oy

13/04/2026

Marginum HIVEN® has been awarded the Red Dot Design Award 2026.

The Dot Design Award recognises products that combine innovation, functionality, and high-quality design. HIVEN® was recognised for its user-centred design in a high-demand clinical environment. Designed to reduce complexity in the operating room, HIVEN® focuses on intuitive interaction, clear feedback, and seamless workflow integration, supporting surgical teams without disrupting the procedure.

Selected from a strong international field of entries, was recognised by the Red Dot jury for its outstanding design and quality. This recognition reflects our commitment to developing technologies that are not only clinically relevant but also designed for real-world use.

Marginum wins the prestigious Red Dot Design Award for HIVEN® device, recognising its innovation in advancing cancer surgery through user-centred design.

30/03/2026

We’re proud to announce a major milestone for Marginum in the United States 🇺🇸 ✨

Marginum has launched a U.S. clinical trial for HIVEN® at the University of Illinois Hospital & Clinics (UI Health) in Chicago. The first patient has now been successfully recruited, and the first-in-human surgical treatment with HIVEN® in the United States has been completed.

The study will evaluate the performance and safety of HIVEN® in a real-world neurosurgical setting, in close collaboration with the UI Health Neurosurgery team. Designed to provide near real-time feedback on tumour margins during surgery, HIVEN® by Marginum Oy seamlessly integrates into standard clinical workflows, supporting surgical decision-making.

The initiation of this trial represents an important step in evaluating the feasibility and performance of the HIVEN® device in the United States. 🙌

Marginum launches a U.S. clinical study with the HIVEN® device at the University of Illinois Hospital & Clinics (UI Health) in Chicago.

19/03/2026

🚀 Distribution partnership for Central Europe

Marginum is excited to announce a strategic distribution partnership with ALMEDA, a Prague-based medical equipment distributor providing hospitals and clinical teams with operating room and ICU/ARO technologies.

Through this collaboration, ALMEDA will distribute Marginum’s CE-marked HIVEN® device in the Czech Republic and Slovakia, expanding access to the breakthrough aspirate tissue monitoring solution across Central Europe. 🇨🇿🇸🇰

The HIVEN® device supports neurosurgical teams by enabling more precise tissue differentiation during fluorescence-guided operations for suspected high-grade gliomas in which 5-aminolevulinic acid (5-ALA) is used, and by assisting surgeons with real-time decision-making in the OR.

By combining Marginum’s HIVEN® device with ALMEDA’s strong local presence and service capabilities, we’re broadening access to advanced surgical technologies that can improve patient care and outcomes. 🌍

ALMEDA, a Prague-based medical equipment distributor, has partnered with Marginum to distribute its HIVEN® device in the Czech Republic and Slovakia.

26/02/2026

LANDMARK STUDY: HIVEN® PERFORMANCE AND SAFETY RESULTS 🔬

Marginum announces the results from a peer-reviewed first-in-human study of HIVEN® aspirate tissue monitoring (ATM) in 5-ALA fluorescence-guided high-grade glioma surgery, published in Neuro-Oncology Advances. ✨

Across 28 procedures at three tertiary hospitals, the HIVEN® device was investigated to detect fluorescence in suction aspirates during tumour resection. Oslo universitetssykehus, Tampereen yliopistollinen sairaala Tays, KYS - Kuopion yliopistollinen sairaala, Pohjois-Savon hyvinvointialue

Key clinical findings 📊:
🔹 ATM detected 5-ALA tumour fluorescence 483% more frequently and for 613% longer than visual fluorescence guidance alone.
🔹 White-light detection: microscope visual inspection detected fluorescence in 0/16 areas, while ATM detected fluorescence in 11/16 (69%).
🔹 Diagnostic correlation: 100% sensitivity and 80% specificity with ATM versus expert visual assessment; no false-positive findings in reported biopsies.
🔹 Safety: no device-related adverse effects reported; 7 experts (+90 years’ experience) concluded ATM appeared safe and value-adding with 96.7% overall agreement.

The CE-marked device is designed to complement conventional fluorescence guidance by detecting 5-ALA–induced PpIX fluorescence in suction aspirates and providing near real-time auditory feedback, supporting decision-making even when visibility is limited.

📄 Study highlights in our press release: https://www.marginum.com/en/news/first-in-human-study-hiven-performance-and-safety-results

We’re grateful to our clinical partners for this important collaboration.💡🤝

A first-in-human study shows that the aspirate tissue monitoring technique using HIVEN® provides 483% more information than visual fluorescence guidance.

29/12/2025

Season’s Greetings from Marginum! ✨

As 2025 comes to a close, we’re proud to reflect on a year filled with growth, milestones and meaningful progress toward our mission of advancing surgical care and improving patient outcomes.

Major milestones we reached together this year:

⚖️ Regulatory & Market Breakthrough: The HIVEN® flagship device achieved EU MDR certification, a pivotal regulatory milestone that brought the aspirate tissue monitoring technology into clinical practice across Europe, marking a new era of precision in cancer surgery.

🔬 Clinical Expansion: Multinational multicenter clinical trial initiated at Oslo University Hospital (Oslo universitetssykehus), HIVEN® usability assessment completed at the Surgical Innovation and Training Laboratory (SITL) at the University of Illinois College of Medicine and U.S. clinical trials launched at Chicago with approval from the University of Illinois Chicago's Institutional Review Board (IRB).

🤝 Strategic Partnerships: Meaningful international distribution partnerships formed – with leading surgical technology partners in the Nordics (Mediplast AB), Spain & Portugal (MBA SURGICAL EMPOWERMENT) and Southeastern Europe (Thomy F.E. d.o.o.) – to expand access to HIVEN® and support surgeons across Europe.

🚀 Funding & Recognition: €2.5 M in Pre-Series A funding secured to progress toward U.S. FDA clearance and accelerate European expansion, setting the stage for further global impact. Furthermore, Marginum was selected for the Business Finland Young Innovative Companies (YIC) program to receive up to €1M in non-dilutive funding – a recognition awarded to Finland’s most promising startups.

None of this would have been possible without the dedication of the Marginum Oy team, the trust of our partners, the insights from clinical collaborators, and the support from the healthcare community.

Thank you for being part of our journey. ❤️

Wishing everyone a joyful holiday season and a prosperous, impactful 2026. Let’s continue moving the needle in surgical innovation together!

© Mayo Clinic

17/12/2025

🚀 Finnish medical innovation in the spotlight!

The Finnish Medical Foundation (Suomen Lääketieteen Säätiö) has announced the first-ever nominees for the Pohjola Medical Innovation Award, with CEO Samu Lehtonen among the top three. The award highlights innovation spanning from drug development to surgical technology, all of which are essential in addressing today’s medical challenges.

Marginum Oy stands out among the nominees as a company that has already achieved EU MDR certification with HIVEN® in commercial clinical use across several European hospitals, exemplifying how research excellence, clinical insight, and entrepreneurship can successfully converge.

🏆 The final award recipient will be announced at the Finnish Medical Convention in January 2026, with the decision made by Planmeca founder and CEO Heikki Kyöstilä.

CEO Samu Lehtonen has been nominated for the prestigious Pohjola Medical Innovation Award in recognition of the Marginum team’s scientific contributions.

12/12/2025

We’re thrilled to announce that The Finnish Medical Society Duodecim has recognised two of Marginum Oy’s co-founders as two of the top influencers in Finnish healthcare for 2025!

Samu Lehtonen MD and Docent Antti-Pekka Elomaa MD PhD were awarded in the ‘Inventive Innovators’ category based on Marginum’s fluorescence-based tissue identification technology for cancer surgery and the commercialised HIVEN® device that enables near real-time differentiation between tumour and healthy tissue.

Thank you, Duodecim, for the honour 🎉

Duodecim on valinnut vuoden merkittävimmät terveysalan vaikuttajat 12 kategoriassa. Valinnoissa painotettiin tämän vuoden ansioita ja 144 vuotta täyttävän Duodecimin arvoja. Terveysalan vaikuttajat TOP 12 kärkeen nousi valtiovarainministeriön (VM) budjettipäällikkö Mika Niemelä. Terveys...

18/11/2025

Next stop: Beahrs Surgical Innovation Summit 2025 hosted by Mayo Clinic Department of Surgery! ✨

We’re excited to be part of on November 18 – an inspiring gathering of forward-thinking surgical innovators. Visit us at the event to learn more about our CE-marked, near real-time aspirate tissue monitoring technology and our plans for the U.S. market.

📌You’ll find Marginum’s kiosk on the 2nd floor of Mayo Civic Center by table 30.

Read more about Marginum and ® on our webpages: https://www.marginum.com/en/solution

03/11/2025

🎉 Big news from Marginum!

We’re proud to share that Marginum has been selected for Business Finland's prestigious Young Innovative Companies (YIC) program – a recognition awarded to Finland’s most promising startups with strong international growth potential. 🇫🇮✨

HIVEN® by Marginum Oy is the world’s first and only intraoperative system that provides continuous feedback on the surgical fluorescence of resected tissue. The CE-marked device provides surgeons with real-time, auditory feedback on traces of cancer during an operation. It is designed to improve surgical outcomes by supporting precise detection of tumour margins, which helps achieve maximal tumour removal and, therefore, reduces the need for reoperations.

Through the YIC program, Marginum will receive up to €1 million in non-dilutive funding and expert guidance to accelerate market expansion, scale production, and build new global partnerships.

We’re grateful to Business Finland for this vote of confidence – and to our exceptional team and partners who continue to make Marginum’s vision a reality. 🙌

🔗 Read the full press release here:

Marginum has been selected for the prestigious Young Innovative Companies (YIC) program, a recognition reserved for Finland’s most promising startups.

20/10/2025

Successful Usability Assessment of HIVEN® at the University of Illinois College of Medicine 🎉

Before new surgical technologies reach the operating room, their safety, usability, and effectiveness must be rigorously validated. Specialised training and research centres like the Surgical Innovation and Training Laboratory (SITL) at the University of Illinois College of Medicine are at the forefront of this process.

Marginum is proud to share that the usability of HIVEN® was successfully evaluated at SITL, a leading ACS-accredited facility for surgical research and innovation. The results confirmed that HIVEN® usability and performance are appropriate for clinical use, marking a key milestone in advancing HIVEN® toward clinical application in the U.S. in collaboration with the professionals from the University of Illinois Hospital & Clinics (UI Health).

Marginum has also obtained a positive decision from the University of Illinois Chicago's Institutional Review Board (IRB) to begin investigational clinical use of HIVEN® in the U.S. The study is planned to start this autumn.

Marginum has completed the HIVEN® usability assessment at the University of Illinois College of Medicine Surgical Innovation and Training Laboratory.

15/10/2025

🚀 Distribution partnership for Southeastern Europe!

Marginum is thrilled to announce a strategic partnership with Thomy F.E., d.o.o., one of Slovenia’s leading distributors of medical and surgical technologies.

Through this collaboration, Thomy F.E. will distribute Marginum’s EU MDR-certified HIVEN® device in Slovenia, Croatia and Bosnia and Herzegovina, bringing the breakthrough aspirate tissue monitoring technology to new markets across Southeastern Europe.

The HIVEN® device enhances surgical performance by providing more precise tissue differentiation during fluorescence-guided surgical operations for suspected high-grade gliomas in which 5-aminolevulinic acid (5-ALA) is used, supporting surgeons in decision-making in the OR. Together with Thomy F.E.’s strong local presence and decades of experience, we are committed to broadening access to advanced surgical innovations that improve patient outcomes.

💬 “We are delighted to collaborate with Thomy F.E., whose deep market knowledge, established relationships with healthcare professionals, and proven track record make them an ideal partner. Their commitment to quality and long-standing presence complements our European growth strategy and reinforces our mission to bring advanced surgical technologies to operating rooms worldwide,” says Samu Lehtonen, CEO of Marginum.

💬 “We are proud to partner with Marginum to introduce the HIVEN® device to our markets. The technology perfectly aligns with our mission to provide healthcare professionals with reliable and advanced tools that enhance surgical precision and patient care. We believe this collaboration will bring meaningful benefits to hospitals and patients across the region,” comments Mojca Goričan, General Manager of Thomy F.E., d.o.o.

By advancing next-generation surgical techniques, we are empowering healthcare professionals to deliver safer, more precise care and improved outcomes for patients. 🌍

Thomy F.E., d.o.o., one of Slovenia’s leading distributors of advanced medical and surgical technologies, has formed a strategic partnership with Marginum.