Prolight Signs USD 3.9 Million Supply Agreement with BRAINBox for TBI Point-of-Care Diagnostics
核心洞察
Prolight Diagnostics (搜索) signed a supply agreement with BRAINBox Solutions (搜索) for instruments and cartridges, with anticipated first-year supply valued at USD 3.9 million (approximately SEK 37 million) post FDA clearance and market launch.
The agreement transitions the collaboration from development into commercial supply, supporting BRAINBox's traumatic brain injury (搜索) diagnostic and prognostic solution built on Prolight's Psyros (搜索) point-of-care platform.
A 260-patient study using samples from BRAINBox's FDA pivotal study set demonstrated strong analytical performance of the Psyros (搜索) platform across three TBI biomarkers.
Prolight Diagnostics (搜索) AB (publ), a pioneer in digital point-of-care testing, announced that it has signed a supply agreement with BRAINBox Solutions (搜索) for instruments and cartridges. The anticipated first-year supply post FDA clearance and market launch is valued at USD 3.9 million (approximately SEK 37 million). The agreement supports the commercialisation of BRAINBox's traumatic brain injury (搜索) (TBI) diagnostic and prognostic solution, built on the Psyros (搜索) point-of-care platform, and follows a development agreement with BRAINBox valued at SEK 29 million announced in July 2026. The parties expect order volumes to increase from the second year onwards as commercialisation progresses.
The supply agreement marks the transition of the collaboration from development activities into commercial supply. It follows the completion of a 260-patient study using samples from BRAINBox's FDA pivotal study set, in which the Psyros (搜索) platform demonstrated strong analytical performance across three TBI biomarkers. The outcome represents an important step toward BRAINBox's planned FDA clearance process. Regulatory clearance of the BRAINBox system would also mark the FDA clearance of the Psyros platform, representing a key milestone for Prolight.
"This supply agreement marks a major milestone for Prolight and the transition into the commercial phase of our collaboration with BRAINBox. Following the successful study results and development agreement announced earlier this year, we are now supporting the planned U.S. launch of a platform that combines ultra-high sensitivity with rapid point-of-care testing. Beyond TBI, we see significant opportunities for Psyros (搜索) across a broad range of neurological and other diagnostic applications," said Ulf Bladin, CEO of Prolight Diagnostics (搜索).
"This agreement is an important step towards commercialization of our solution and reflects the successful progress of our collaboration with Prolight. We look forward to continuing our joint efforts as we prepare for market launch and broader adoption of our neurology portfolio," said Donna J. Edmonds, CEO of BRAINBox Solutions (搜索).
To support the anticipated growth in volumes, Prolight's manufacturing partners, G&H I ITL (搜索) and FlexMedical Solutions (搜索), will further expand production capacity. Increased manufacturing scale is expected to improve cost efficiency and the competitiveness of the Psyros (搜索) platform as additional assays and applications are introduced.
Prolight Diagnostics (搜索) develops Psyros (搜索), a point-of-care platform for highly sensitive biomarker diagnostics. By delivering reliable test results in ten minutes or less, Psyros has the potential to revolutionize clinical workflows, improve patient outcomes, and reduce healthcare costs. The platform is initially being developed for areas with significant unmet medical needs such as cardiovascular and neurological conditions and possesses broad potential for a wide range of clinical applications.