Spectral AI Inc (NASDAQ:MDAI) announced that it has added two US clinical trial sites to its 2024 burn study, the University of California San Diego and the University of Utah.
The medical diagnostics company said the addition of these new locations expands the total number of US clinical trial sites to 14.
Spectral AI’s US Burn Pivotal Study is designed to validate the AI-driven algorithm used by Spectral AI’s DeepView System for the burn indication.
The DeepView System is a predictive device that offers clinicians an objective and immediate assessment of a wound’s healing potential prior to treatment or other medical intervention, which is expected to provide faster and more accurate treatment insights.
“These two new sites allow us to capture additional burn patients who enter through the Emergency Department and thus complement our existing trial site presence at burn centers across the country, establish our presence in new geographies, and advance us towards our objective of completing this study by the end of the year,” Spectral AI CEO Peter Carlson.
“Moreover, a broader base of clinical trial sites provides access to a more diverse patient population, reduces bias, and provides the opportunity to elevate the profile of our DeepView System across a wider range of clinicians and healthcare settings.”
Spectral AI’s study is expected to be completed in the fourth quarter of 2024.
It is expected to be the final clinical trial before the company seeks FDA approval of the DeepView System for burn indication in 2025.