Marginum’s HIVEN® device is cleared for CE mark
Marginum announces a significant milestone as its flagship device, HIVEN®, is cleared for the CE mark. The underlying MDR certification signifies an important regulatory milestone
Marginum, a leading innovator in fluorescence-guided oncological surgery, is a Finnish physician-led medical technology company driven by a team of multidisciplinary experts. The company has made rapid strides in validating the aspirate tissue monitoring (ATM) technique and has received the MDR certificate, followed by a market entry at a record-breaking speed – just over 4.5 years. Marginum’s team successfully developed a breakthrough medical device that addresses an unmet clinical need to accurately detect tumourous tissue during surgery, while seamlessly integrating into existing surgical workflows.
New era of precision in cancer surgery
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 providing 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 fluorescent cancer tissue from aspirated tissue during surgery without disrupting standard workflow.
“Achieving clearance for the CE mark is a pivotal step in bringing the HIVEN® into clinical practice and improving outcomes for patients in Europe”, says Juho Leskinen, CTO and co-founder of Marginum. “This certificate reflects the hard work of our team and the strength of our scientific and clinical foundations.”
Clinical benefits & indications
The MARGINUM® aspirate tissue monitoring technology aims to overcome surgical challenges that may damage healthy tissues and leave tumour cells undetected. Incomplete removal, damage to healthy tissues, and reoperations exacerbate patient suffering, compromised standard of care, and long-term complications – all directly escalating healthcare costs.
Critical structures like blood vessels often create blind spots – behind corners and tissue ridges – where cancerous tissue can be difficult to detect. The HIVEN® aspirate tissue monitoring device addresses this challenge by allowing resected tissue to be transported directly for fluorescence analysis. This provides surgeons with more comprehensive information about the surgical site.
“In glioma surgery, our ability to distinguish tumour from healthier tissues is limited by anatomical constraints, blood and compromised visibility, particularly in deep-seated areas. We wanted HIVEN® to provide critical feedback beyond sensory limitations; you can consider it a sixth sense for tumour detection.”, comments docent Antti-Pekka Elomaa MD PhD, a consultant neurosurgeon and one of Marginum co-founders.
The device’s unique design reduces the interference of blood and debris, which typically obscures fluorescence signals. This makes fluorescence assessment more reliable than conventional imaging tools, such as surgical microscopes.
The HIVEN® is approved for fluorescence-guided neurosurgery of high-grade gliomas, where precise margin identification is critical. HIVEN® enhances surgical accuracy by enabling objective tissue detection in hard-to-reach areas and simplifying the procedure workflow.
Additional information:
Samu Lehtonen
CEO, Marginum
samu.lehtonen@marginum.com
+358 40 579 7890