Prolight Diagnostics today announces the successful completion of a 260-patient feasibility study and the subsequent signing of a development agreement with BRAINBox Solutions. The agreement generates revenues of approximately GBP 2.24 million (SEK 29 million) of which GBP 2,09 million (SEK 27 million) is to be recognized during the second half of 2026.
In the feasibility study, Prolight evaluated 260 patient samples from BRAINBox´s FDA Pivotal Study set on the Psyros point-of-care (POC) platform using three assays for traumatic brain injury (TBI). The results demonstrated excellent performance. The outcome supports an expanded collaboration and represents an important step toward BRAINBox’s planned FDA clearance process. Regulatory approval of the BRAINBox system would also mark the U.S. market approval of the Psyros platform, representing a key milestone for Prolight.
The development agreement covers the development of advanced multiplex cartridges, software and the initial purchase of pilot instruments.
“The expansion of our collaboration with BRAINBox represents a strong validation of the Psyros platform. The agreement provides funded development and near‑term revenues, while advancing our multiplex capabilities. It also enables us to progress the platform in a capital‑efficient manner together with a strong partner,” said Ulf Bladin, CEO of Prolight Diagnostics.
“The 260-patient feasibility study demonstrated excellent performance of the Psyros platform in a proprietary assay format, supporting its suitability for TBI as well as the other diagnostic products in our IP protected neurology portfolio. This gives us confidence to expand the collaboration as we advance toward regulatory approval and commercialization in the U.S and elsewhere” said Donna J. Edmonds, CEO of BRAINBox Solutions.
The TBI development program complements Prolight’s high-sensitivity troponin strategy by leveraging the same core capabilities for ultra-sensitive biomarker detection. This further validates the platform’s precision and multiplex potential in clinically demanding settings. The TBI program therefore represents both a major commercial opportunity and a source of near-term revenue, while reinforcing the broader applicability of the Psyros platform beyond the cardiovascular area.