Spectral AI is developing an AI-guided predictive medical device that employs multispectral imaging (MSI) to estimate a wound's capacity to heal. The company is pursuing indications in burn and diabetic foot ulcers (DFUs) with the former receiving 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. 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.
