Spectral AI Inc (NASDAQ:MDAI) announced that the final group of patients at burn centers in its US Burn Pivotal Study have completed their clinical visits, with topline results expected in December 2024.
This study is expected to be the final clinical trial before Spectral AI seeks Food and Drug Administration (FDA) approval for its DeepView System, a medical device that can assess burn wounds non-invasively.
DeepView AI Burn can differentiate healing from non-healing tissue, providing clinicians with an immediate assessment to inform their treatment plan.
The study, initiated in January 2024, involved 160 adult and pediatric patients at 14 burn centers across the US.
Dr J Michael DiMaio, Spectral AI board chairman, noted the completion of the study as a critical milestone for the company on its path towards commercialization.
“These results will form the foundation of our forthcoming US regulatory submission and brings us one step closer to delivering a potentially groundbreaking advancement in burn wound assessment that can support clinical decision-making regarding next step treatment plans, broaden equity in access to burn care treatment, and improve clinical outcomes,” DiMaio said.
Shares of Spectral AI moved 2.8% higher on Wednesday morning.
--Updated with share price movement--