Spectral AI Initiates Pivotal Study Evaluating DeepView AI® for Burn Injuries
Medical diagnostics AI company Spectral AI, Inc. (Nasdaq: MDAI) has enrolled the first patient in a pivotal study to validate DeepView AI® using its proprietary imaging technology for burn size and healing assessment.
This study is expected to be the final clinical trial before seeking FDA marketing authorization for the burn indication in 2025 and will be conducted in burn centers and emergency departments across the US, enrolling both adults and pediatric patients.
Commenting on the study, Niko Pagoulatos, Ph.D Spectral AI Chief Operating Officer, stated, “We believe this study will further demonstrate the truly innovative and versatile nature of our technology, as well as its ability to predict burn wound healing potential on the first day of injury with significantly greater accuracy and speed than the methods currently used today. We continue to utilize $251 million of non-dilutive government funding since 2019 to validate DeepView for burn indication, while aggressively advancing other clinical indications like diabetic foot ulcers in pursuit of our ‘one platform—multiple clinical indications’ strategy.”
Jeffrey C. Carter, MD, FACS, the study’s lead investigator, said, “This study is anticipated to deepen the knowledge and understanding of how DeepView will transform burn care pathways while improving patient outcomes, concurrently strengthening our country against the challenges of Burn Mass Casualty Incidents to safeguard and prepare for unforeseen emergencies.”
Spectral’s study is being supported with federal funds from the Department of Health and Human Services (HHS), Administration for Strategic Preparedness and Response (ASPR) and the Biomedical Advanced Research and Development Authority (BARDA).
About Spectral AI
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 the management of wound care by “Seeing the Unknown®” with its DeepView system. DeepView is a predictive diagnostic device that offers clinicians an objective and immediate assessment of a wound’s healing potential prior to treatment or other medical intervention. With algorithm-driven results and a goal of substantially exceeding the current standard of care in the future, DeepView is expected to provide faster and more accurate treatment insight towards value care by improving patient outcomes and reducing healthcare costs. For more information about DeepView, visit www.spectral-ai.com.
