Spectral AI has developed an AI-guided predictive medical device that harnesses multispectral imaging (MSI) to estimate a wound's capacity to heal. It is pursuing indications in burn and potentially other indications with support from BARDA & other government agencies. Spectral is distinguished by its combination of MSI and AI to improve diagnoses. Spectral is conducting multiple clinical trials around the world to obtain approval for its device with the FDA & other regulatory agencies. In 2Q:25, a pivotal burn study was submitted to the FDA using the De Novo pathway and clearance was given in May 2026. The device has received the UKCA mark for burn in the UK & has deployed devices in Australia. The company is also pursuing the CE mark in Europe. Spectral will consider new diagnostic areas for DeepView such as amputation & critical limb ischemia. We forecast DeepView product revenues from burn centers & emergency departments using a licensing fee model that provides access to service, training & algorithm updates. Device sales & per transaction fees may also be part of the reimbursement model. Geographical opportunities include US, the UK and EU with potential for broader distribution.
