Lumito awarded Vinnova funding to strengthen regulatory and quality capabilities during commercialisation
Lumito AB (“Lumito” or the “Company”) today announces that it has been awarded funding of up to SEK 200,000 from Vinnova under the “Medtech4Health: Competence Enhancement in SMEs, Spring 2026” programme.
The project will run from May to December 2026 and is intended to strengthen the Company’s regulatory competence, with a particular focus on quality management systems during the commercialisation phase. The initiative includes identifying and clarifying regulatory requirements, processes and areas of responsibility, as well as further developing operational procedures tailored to commercial sales to industrial customers, research organisations and pharmaceutical companies.
The project will also include an assessment of relevant quality standards and frameworks, including ISO 13485, ISO 9001 and GLP frameworks, as part of the Company’s regulatory strategy and continued development. The goal is to ensure a quality management system that is aligned with both regulatory requirements and customer expectations, while supporting the Company’s long-term strategic direction, including future steps towards IVDR compliance.
The project will support a more scalable and efficient way of working, with greater internal alignment around quality, responsibilities and customer offering, while reducing the risk of future regulatory obstacles and unnecessary administrative burden.
“We are delighted to have been awarded this funding from Vinnova and Medtech4Health. It strengthens our ability to develop both our organisation and quality management systems in line with our commercialisation efforts, with the aim of establishing a fit-for-purpose and efficient quality system that supports both our current needs and the next stage of our development,” says Sanna Wallenborg, CEO of Lumito.
For further information, please contact:
Sanna Wallenborg, CEO Lumito
E-mail: sw@lumito.se
Ph: +4670-870 01 68
About Medtech4Health
Medtech4Health is a national strategic innovation programme funded by Vinnova, the Swedish Energy Agency, and Formas. The programme brings together stakeholders from healthcare and social care, academia, and industry, with strong involvement from patients and citizens, to accelerate the development and implementation of medical technology innovations that strengthen Swedish healthcare and deliver real patient benefit. Learn more at: https://medtech4health.se/start_en/
About Lumito
Lumito specialises in medical technology and translational research in digital tissue imaging. Lumito offers a groundbreaking, highly sensitive imaging technique to locate and measure protein biomarkers in tissue samples using up-converting nanoparticles (UCNPs) through its patented research platform. The technology combines image data with precise biomarker detection, enabling images with higher contrast where irrelevant background information is filtered out. The technique can enhance the analysis of tissue samples by increasing objectivity, thereby contributing to research for more quantifiable diagnoses and optimised treatments. Lumito primarily focuses on drug development and digital pathology and is a spin-off from a research group at Lund University's Department of Atomic Physics and Laser Center. www.lumito.se/en/
The share is traded on NGM Growth Market under the name LUMITO, and Mentor is Mangold Fondkommission.
Bifogade filer