HIVEN® multinational clinical trial launched at Oslo University Hospital

Marginum has initiated a multicentre controlled trial to investigate the clinical performance and outcomes of using an aspirate tissue monitoring device HIVEN®. The device detects tissue fluorescence from the suction waste during surgical treatment of malignant brain tumours. The first patients have been treated at Oslo University Hospital with the novel surgical method.

During glioma surgery, the diffuse boundary between healthy tissue and tumour is localised using 5-ALA drug-enhanced fluorescence of cancer cells. Visual fluorescence-based tissue recognition technique using 5-ALA has been shown to improve the rate of tumour removal and slow disease progression. To see the fluorescence, a special light source is needed in the operating microscope. In blue light, the fluorescence is visible, but it is more difficult to detect anatomical landmarks, such as cerebral blood vessels and cranial nerves, which makes them vulnerable to injuries. Tumour cells can also be unnoticed because of visual obstacles or weak fluorescence, which may lead to local recurrence and reoperations. Unintended tumour remnants are frequent even though many other auxiliary techniques such as MRI guidance, neuronavigation, ultrasound and neurophysiological monitoring are used.

HIVEN® provides near real-time audible feedback to the surgeon when fluorescence is detected in the aspirated tissues. The multinational trial investigates the long-term clinical outcomes from the use of HIVEN® to detect 5-ALA-induced fluorescence, including the frequency of reoperations.

“We are proud that Oslo is participating in our multicentre trial investigating the long-term outcomes of glioma patients undergoing fluorescence-guided surgery. The aspirate tissue monitoring technique has been successfully implemented in their practice”, says Marginum co-founder and chairman of the board Chief Antti-Pekka Elomaa, who is also a consultant neurosurgeon.

Every year, 300+ patients are operated on for high-grade gliomas in Norway, and over 50 % of their surgical procedures are performed at the Oslo University Hospital. The hospital’s neurosurgical team is led by Professor Einar O. Vik-Mo, a neurosurgeon specializing in brain tumour surgery. They employ the best practices, such as intraoperative MRI, resulting in excellent outcomes by international standards.

Additional information:

Samu Lehtonen MD
CEO, Marginum Ltd
samu.lehtonen@marginum.com
+358 40 579 7890
 
Marginum Ltd is a medical technology company and market forerunner in quantitative surgical techniques developing fluorescence-based optical tissue monitoring technologies. Backed by Redstone, Nostetta Ventures and Almaral, the company’s data-driven solutions enable the monitoring of tissues during cancer surgery and treatments. The products are derived from state-of-the-art research to improve surgical performance and cost-effectiveness. Marginum’s multidisciplinary team works in close cooperation with academic, clinical and industrial experts to ensure its technological solutions’ seamless clinical compatibility. www.marginum.com