Marginum Achieves Record-Breaking CE Mark Clearance for HIVEN®—Ushering in a New Era of Precision in Neurosurgical Oncology
HELSINKI, Finland – In a landmark achievement for surgical innovation and regulatory efficiency, Finnish medtech pioneer Marginum has announced that its flagship device, HIVEN®, has received CE Mark certification under the European Union’s stringent Medical Device Regulation (MDR)—a milestone accomplished in a record-breaking timeframe of just over 4.5 years from concept to certification. This rapid validation underscores both the urgency of the clinical need HIVEN® addresses and the exceptional execution of Marginum’s scientific, engineering, and regulatory teams.
The CE Mark clearance for HIVEN®, classified as a Class IIb medical device, authorizes its commercial use across the European Economic Area (EEA) and marks a pivotal step toward transforming intraoperative decision-making in neurosurgery—particularly in the resection of aggressive brain tumors such as high-grade gliomas. Designed to integrate seamlessly into existing surgical workflows, HIVEN® introduces a novel Aspirate Tissue Monitoring (ATM) technique that delivers near real-time feedback on tumor margins, empowering surgeons to achieve more complete and precise tumor removal while preserving critical healthy brain tissue.
A Breakthrough in Intraoperative Tumor Detection
At the heart of HIVEN®’s innovation is its ability to analyze aspirated tissue—material suctioned away during standard tumor resection—for the presence of fluorescently labeled cancer cells. In fluorescence-guided surgery (FGS), patients are administered a compound such as 5-aminolevulinic acid (5-ALA), which causes malignant glioma cells to glow under blue light. While this technique has improved visualization, it remains limited by line-of-sight constraints, blood interference, tissue depth, and anatomical blind spots—especially near critical structures like blood vessels or deep within brain folds.
HIVEN® overcomes these limitations by capturing resected tissue that would otherwise be discarded and instantly analyzing it for fluorescence. This provides surgeons with objective, quantitative data about whether tumor cells are still present at the resection margin—even in areas they cannot directly see. The result is a form of “sixth sense” for tumor detection, as described by Marginum co-founder Dr. Antti-Pekka Elomaa, a consultant neurosurgeon and docent at the University of Helsinki.
“In glioma surgery, our ability to distinguish tumor from healthier tissues is limited by anatomical constraints, blood, and compromised visibility, particularly in deep-seated areas,” Dr. Elomaa explains. “We wanted HIVEN® to provide critical feedback beyond sensory limitations—you can consider it a sixth sense for tumor detection.”
Addressing a Critical Unmet Clinical Need
Incomplete tumor resection is a persistent challenge in neuro-oncology. Studies show that even with advanced imaging and fluorescence guidance, residual tumor tissue is left behind in a significant percentage of glioma surgeries. This not only increases the risk of tumor recurrence but often necessitates repeat operations, prolonged hospital stays, and intensified adjuvant therapies—all of which diminish quality of life and escalate healthcare costs.
Moreover, overly aggressive resection in an attempt to remove all visible tumor can inadvertently damage eloquent brain regions responsible for speech, motor function, or cognition, leading to permanent neurological deficits. The delicate balance between maximal safe resection and functional preservation demands tools that offer greater certainty than the human eye alone can provide.
HIVEN® directly addresses this dilemma. By enabling real-time assessment of aspirated tissue, it allows surgeons to confirm whether their resection margins are truly tumor-free—without altering their surgical technique or adding procedural complexity. The device is designed to sit unobtrusively at the surgical field, connected to standard suction systems, and delivers results within seconds.
Record-Breaking Regulatory Achievement Under MDR
The speed of Marginum’s regulatory success is particularly noteworthy given the rigorous demands of the EU MDR, which came into full application in 2021 and has significantly raised the bar for clinical evidence, risk management, and post-market surveillance. Achieving CE Mark certification in just over four and a half years—from initial concept through prototype development, preclinical validation, clinical studies, and conformity assessment—represents one of the fastest pathways to market for a novel Class IIb surgical device under the new regulation.
“This certificate reflects the hard work of our team and the strength of our scientific and clinical foundations,” said Juho Leskinen, CTO and co-founder of Marginum. “Achieving clearance for the CE mark is a pivotal step in bringing HIVEN® into clinical practice and improving outcomes for patients in Europe.”
The rapid timeline speaks to Marginum’s disciplined development approach, close collaboration with notified bodies, and strong alignment with clinical stakeholders from the earliest stages of design. It also highlights growing regulatory recognition of technologies that demonstrably enhance patient safety and surgical efficacy.
Clinical Indications and Broader Implications
HIVEN® is initially approved for use in fluorescence-guided resection of high-grade gliomas—among the most aggressive and difficult-to-treat primary brain tumors. In these cases, the extent of resection is a well-established predictor of survival. Every millimeter of residual tumor can impact prognosis, making tools like HIVEN® potentially life-extending.
However, the underlying ATM technology holds promise beyond neurosurgery. Marginum envisions future applications in other oncologic surgeries where fluorescence guidance is used—such as bladder cancer, head and neck tumors, and certain gastrointestinal malignancies—where similar challenges of margin assessment and blind-spot resection exist.
A New Standard in Surgical Precision
With CE Mark in hand, Marginum is now preparing for commercial rollout across European neurosurgical centers, beginning with key markets in Germany, France, the UK, and the Nordics. The company is also engaging with clinicians and hospital procurement teams to integrate HIVEN® into standard operating protocols and training curricula.
As healthcare systems increasingly prioritize value-based care, technologies that reduce reoperation rates, shorten recovery times, and improve long-term outcomes are gaining strategic importance. HIVEN® aligns perfectly with this shift—offering not just a technical innovation, but a clinical and economic solution to a decades-old surgical challenge.
In the words of its creators, HIVEN® is more than a device—it is a new paradigm in cancer surgery. By turning discarded aspirate into actionable intelligence, it transforms uncertainty into confidence, guesswork into data, and incomplete resections into curative opportunities. With its record-setting CE Mark clearance, Marginum has not only validated its technology but has also signaled the dawn of a new era in precision neurosurgery—one where every resection is guided not just by skill, but by real-time insight.
