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.
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Figure 1. MARGINUM® intraoperative aspirate tissue monitoring device (HIVEN®) was used at Nordic hospitals during clinical trials. The device is positioned on the instrument table next to the surgeon.
Marginum, a Finnish medical technology company, made rapid strides in validating the aspirate tissue monitoring (ATM) technique and received the MDR certificate at a record-breaking speed, just over 4.5 years. Marginum's team successfully developed a breakthrough class IIb medical device that addresses an unmet clinical need to accurately detect tumorous tissue during surgery, without compromising existing workflows.
New era of precision in cancer surgery
HIVEN is a novel device for assisting in intraoperative margin assessment that provides 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 margins while resecting, the device aims to improve patient 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. This certificate reflects the hard work of our team and the strength of our scientific and clinical foundations," says Juho Leskinen, CTO and co-founder of Marginum.
Clinical Benefits Indications
The 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 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.
About Marginum:
Marginum, a leading innovator in fluorescence-guided oncological surgery, is a medical technology company developing fluorescence-based tissue detection systems. HIVEN by Marginum enables safe and efficient monitoring of tumour tissues during cancer surgery. www.marginum.com
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Contacts:
Media contact:
Samu Lehtonen, CEO Co-Founder
Email: samu.lehtonen@marginum.com
Mobile: +358405797890
https://www.marginum.com
