Marginum started clinical trials of a new technique for tumour surgery

Marginum Ltd has initiated its first-in-human clinical trials. It is the first time in the world that this type of technology is brought into the operating theatre.

”Our goal is to refine our technique into a golden standard for fluorescence-guided surgery of tumours”, says docent Antti-Pekka Elomaa, a neurosurgeon and the Chairman of the Board of Marginum Ltd, about the tissue recognition solutions developed by the company.

The aspirate tissue monitor is attached around a surgical suction tube, which removes tissue waste during the operation. The device monitors the waste and informs the surgeon if there are traces of a tumour within. The tumour is detected in near real-time based on its characteristic fluorescence, which is conventionally done by looking at the glow through a surgical microscope equipped with special optic systems. But research has shown that failing to see fluorescence is contributed by visual obstacles such as debris and the weakness of the glow. The aspirate tissue monitoring provides the surgeon with objective and unprecedentedly accurate feedback about the fluorescence without extra effort. By assisting the surgeon in fluorescence detection, tumour removal rates and safe margins can be improved. This is expected to lead to fewer complications and reoperations of local recurrences, resulting in healthcare savings and the best possible outcome for the patients.

PROMISING CLINICAL TRIALS RESULTS 

The first investigated indication for the method is gliomas, which include the most common types of primary malign brain tumours. “We managed to verify the proof-of-concept, collect valuable clinical data and test the performance of a prototype with promising resulsts", says CEO Samu Lehtonen about the ongoing clinical trials. Although the device will still be further developed to meet the targeted performance requirements, the results are already evident. Plans to optimize the sensitivity and specificity of the tissue analysis have been made and are implemented in the following weeks.

CONCRETE BENEFITS OF THE METHOD FOR THE SURGEON

The aspirate tissue monitoring technique provides the surgeon ‘visibility’ behind blind corners and tissue ridges resulting from critical structures such as vessels. The suction device can reach behind those corners and as the removed tissues are transported to the device for analysis, more information can be gained from the resected area. The surgeon can also confirm any signs of weak fluorescence by removing a small piece, and concluding whether it was likely cancerous or not.

The surgeon’s decision-making is also improved by making the analysis of fluorescence less susceptible to blood and tissue debris that obstructs the field of vision because the tip of the suction device can work ‘behind’ edges. Achieving equivalent visibility on fluorescence is challenging with intraoperative imaging devices such as a surgical microscope. Therefore, the technology enables objective tissue identification in areas that would have been likely missed while using contemporary techniques alone. And the surgical workflow is simplified by reducing the need for operation room light source adjustments.

CLOSE RESEARCH COLLABORATION WITH ACADEMIC AND CLINICAL EXPERTS

The company has worked closely with Kuopio University Hospital and the University of Eastern Finland, and many international collaborators since the inception of the innovation.

“Our method avails the underutilized waste tissues and offers the surgeon performance that has not been possible with any of the current techniques. The development of the solution to its current form would not have been possible without the valuable feedback and cooperation with the experts”, states CEO Lehtonen.

In addition to neurosurgery, the method could be integrated into other surgical fields to make it applicable to most other types of tumours, such as gastrointestinal cancer, liver cancer and ovarian cancer.

DEVELOPMENT CO-FUNDED BY THE EUROPEAN UNION

The development was co-funded with 120,000 EUR by the European Union Structural Funds and the Centre for Economic Development, Transport and Environment. In the project, Marginum facilitated commercialisation by promoting product development, readiness for EU control of medical devices, conducting clinical trials to support the certification of a new product, and protecting IP rights critical to internationalisation. The objectives of the project were successfully achieved – a prototype of the first product was developed and tested in a clinical setting while critical immaterial property rights for market entry were secured.

Published in:

• Neurocenter Finland 2023 ‚Marginum – A device developed by researchers can improve cancer surgery‘ https://neurocenterfinland.fi/en/marginum-a-device-developed-by-researchers-can-improve-cancer-surgery/
• University of Eastern Finland 2023 ‚A device developed by researchers can improve cancer surgery – clinical trials initiated at KUH' https://www.uef.fi/en/article/a-device-developed-by-researchers-can-improve-cancer-surgery-clinical-trials-initiated-at-kuh
• Wellbeing services county of North Savo 2023 ‚Tutkijoiden kehittämä laite voi tarkentaa syöpäkirurgiaa – kliiniset tutkimukset potilailla käyntiin KYSissä‘ https://pshyvinvointialue.fi/w/tutkijoiden-kehittämä-laite-voi-tarkentaa-syöpäkirurgiaa-kliiniset-tutkimukset-potilailla-käyntiin-kysissä
• Kuopio Health 2023 ‚Tutkijoiden kehittämä laite voi tarkentaa syöpäkirurgiaa – kliiniset tutkimukset potilailla käyntiin KYSissä‘ https://kuopiohealth.fi/tutkijoiden-kehittama-laite-voi-tarkentaa-syopakirurgiaa-kliiniset-tutkimukset-potilailla-kayntiin-kysissa/
• Kuopio Health 2023 ‚TKI-toimijat valokeilassa – Itä-Suomen Mikrokirurgiakeskus‘ https://kuopiohealth.fi/tki-toimijat-valokeilassa-ita-suomen-mikrokirurgiakeskus/

Additional information:

Samu Lehtonen
CEO, Marginum Ltd
samu.lehtonen@marginum.com
+358 40 579 7890
 
Marginum Ltd is a medical technology company founded in 2020 at Kuopio. The company develops a new tissue identification technique for cancer surgery rooted in the interdisciplinary and internationally awarded research on fluorescent biomarkers.