Burn Study Enrollment Completed

Spectral AI Inc. has finished enrolling adult and pediatric patients in its U.S. Burn Pivotal Study. One of the largest domestic burn trials ever conducted, the U.S. Burn Pivotal Study is designed to validate the AI-driven algorithm used by the company’s DeepView System for burn indication.
 
Using data from these burn center patients, Spectral AI will apply for U.S. Food and Drug Administration (FDA) De Novo classification for use of the DeepView System in burn centers. The company expects to submit the De Novo application in Q2 2025.
 
“We met our burn center enrollment goal much sooner than anticipated due to the dedication of our team and the support of study participants,” Spectral AI CEO Peter M. Carlson said. “This milestone achievement will allow us to begin data analysis and advances our product commercialization timeline.” 
 
Spectral AI’s DeepView System for burn indication is a predictive medical device that assesses the healing potential of burns by combining multi-spectral imaging with an AI-driven algorithm trained and tested against a proprietary database of more than 340 billion clinically validated data points. By distinguishing between healing and non-healing tissue, the DeepView System provides an immediate and binary prediction of wound healing on the first day that can support clinical decision-making regarding next step treatment plans. The DeepView System has demonstrated superior accuracy in assessing burn wounds compared to the current standard of care.

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READ MORE: Spectral AI, PolyNovo Team Up to Deploy DeepView System in Australia

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“I am proud of the work by our investigators, their dedicated staff and most critically study enrolees,” stated Jeffrey Carter, M.D., the study’s principal investigator. “We enrolled 160 patients in less than eight months, in what we believe to be one of the fastest enrolling burn studies ever completed in the U.S. The results will be used by our data science team and our panel of burn experts to complete years of work and bring this crucial advancement in burn wound assessment to patients and providers in the U.S.”
 
The company is continuing to enroll patients at hospital emergency departments (ED) as part of the U.S. Burn Pivotal Study, with such enrollments expected to continue into 2025. A subsequent FDA 510(k) application will be submitted for the DeepView System”s use in EDs once enrollment is completed, associated data is analyzed, and the FDA approves the DeepView System’s use in burn centers.
 
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 allows clinicians to objectively and immediately assess 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.