Spectral AI’s U.S. Burn Study Nearing its End

There’s a proverbial light at the end of the tunnel: The final patients in Spectral AI Inc.’s U.S. Burn Pivotal Study have successfully completed their clinical visits.

One of the largest domestic burn center trials ever conducted, the U.S. Burn Pivotal Study is reportedly the final clinical trial before the company seeks U.S. Food and Drug Administration (FDA) approval of its DeepView System for burn indication (DeepView AI-Burn) in H1 2025. DeepView AI-Burn is a non-invasive, predictive medical device designed to distinguish between healing and non-healing tissue to provide clinicians with an immediate and binary assessment of a burn wound’s healing potential.

Spectral AI expects to report topline results from this study next month.

“The completion of this aspect of the U.S. Burn Pivotal Study marks a critical milestone on our path towards commercialization,” Spectral AI Board Chairman Dr. J. Michael DiMaio said. “These results will form the foundation of our forthcoming U.S. 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. I want to thank our investigators, their dedicated staff, and study enrollees for their support in this endeavor.”

The U.S. Burn Pivotal Study was initiated in January 2024 and involves 160 adult and pediatric patients at 14 burn centers across the country. It is designed to validate the AI-driven closed loop algorithm used by DeepView AI-Burn. Each patient underwent non-invasive imaging of their wound using DeepView AI-Burn beginning at the initial clinical assessment through the treatment plan’s defining. An end image was required 21 days after the initial assessment.

Spectral AI, Inc. is a Dallas-based predictive AI company focused on medical diagnostics for faster and more accurate treatment decisions in wound care, with initial applications involving patients with burns and diabetic foot ulcers. The company is working to revolutionize wound care management by “Seeing the Unknown” with its DeepView System, a predictive device that offers clinicians an objective and immediate assessment of a wound’s healing potential before treatment or other medical intervention. With algorithm-driven results and a goal to change the current standard of care, the DeepView System is expected to provide faster and more accurate treatment insight towards value care by improving patient outcomes and reducing healthcare costs.