15.10.2024 | Marginum News
Marginum brings a groundbreaking advancement in oncological surgery to the operating theatres. The HIVEN® device provides unforeseen near real-time aspirate tissue monitoring in fluorescence-guided glioma surgeries to improve surgeons' decision-making. In close collaboration with Tampere University Hospital, the first patient was successfully treated with the help of aspirate tissue monitoring technology.
“Brain cancer is a devastating disease, and we need better tools for surgical treatment. We now have an opportunity to study the possible benefits of optical tissue recognition methods in neurosurgery. Especially, the greater extent of tumour resection, performed without compromising patient safety, would be of interest”, comments Joonas Haapasalo, who is a consultant neurosurgeon with a focus on neuro-oncological diseases.
Following extensive preclinical and clinical evaluations, Marginum has acquired permission from the Finnish Medicines Agency (Fimea) and the approval of the Ethics Committee to conduct clinical trials on high-grade glioma surgeries at the Tampere University Hospital and Kuopio University Hospital.
“The HIVEN® device has been developed in close collaboration with neurosurgeons and regulatory authorities. This is a significant milestone, and we are happy to see years of hard work translated into practice for the benefit of the patients”, says Marginum CEO Samu Lehtonen.
Gliomas account for the most common malignant primary central nervous system tumours in developed countries. While high-grade gliomas are aggressive, their recommended treatment is surgical resection and chemoradiation. But complete tumour removal is challenging because of diffuse cell growth and the proximity of functionally important brain tissues.
The tumour margins cannot be reliably identified under natural white light illumination, so neurosurgeons utilise 5-aminolevulinic acid (5-ALA) drug-induced fluorescence and a special blue light filter system to visualise the tumour margins. In blue light, it is difficult to see other important tissues, such as blood vessels and cranial nerves, which makes them vulnerable to injury. Despite the use of visual fluorescence-guidance and various other adjunct techniques, tumour cells are often left unnoticed. While using surgical microscopes, the cancer-related fluorescence can be unintentionally left behind because of visual obstacles or weak fluorescence, which can lead to tumour recurrence and reoperations. The cancerous tissues are removed using surgical suction devices, but so far, the suction aspirate tissues have not been routinely used in tissue detection.
“We are the first to develop aspirate tissue monitoring during surgery using the HIVEN® device. The feedback from the device is expected to improve the workflow of the operations and the identification of tumours, leading to fewer reoperations and better treatment outcomes”, notes Marginum Chief Medical Officer Sami Puustinen.
The HIVEN® device is attached to the suction tube of a tissue aspirator and provides near real-time auditory feedback to the surgeon when fluorescent cells are detected in the aspirated tissues. The tumour cells are differentiated from healthier regions using drug-induced fluorescence. Feedback from the fluorescence can be obtained under natural white light, unlike with microscopes where illumination needs to be switched between blue and white light illuminations.
The ongoing multicenter clinical trial aims to investigate the clinical performance and outcomes of this new method for detecting tumour tissues from the suction aspirates in near real-time based on 5-ALA-induced fluorescence.
“Reaching this point when we can conclude that HIVEN® is safe and effective has taken a tremendous amount of dedication. We are thankful for our supporters, who have helped us get this technology validated and accessible to surgeons globally”, says Marginum co-founder and chairman of the board Antti-Pekka Elomaa, who is also a consultant neurosurgeon.
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
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