Spectral AI Inc (NASDAQ:MDAI) said it has started enrollment for a pivotal study of DeepView AI, utilizing its proprietary imaging technology for burn size and healing assessment.
The study is a crucial step towards obtaining Food and Drug Administration (FDA) marketing authorization for burn indication in 2025, the Dallas-based company said in a statement.
The first patient has been enrolled in the trial, which is set to take place in burn centers and emergency departments across the United States. Spectral AI aims to showcase the capabilities of its technology in predicting burn wound healing potential on the first day of injury with unprecedented accuracy and speed compared to current methods.
"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,” Niko Pagoulatos, Spectral AI’s CEO said in a statement.
Spectral AI has strategically utilized $251 million in non-dilutive government funding since 2019 to validate DeepView for burn indication, concurrently advancing research in other clinical areas such as diabetic foot ulcers. The company follows a 'one platform—multiple clinical indications' strategy to broaden its impact in the medical diagnostics field.
The study will help Spectral AI validate DeepView’s technology to accurately assess burn wound healing potential on “day one”, which could lead to early treatment decisions, the study’s lead investigator Jeffrey Carter said.
“The study will help us validate DeepView’s game-changing AI to accurately assess burn wound healing potential on day-one which could lead to early treatment decisions."
The data collected during the study will be compared to assessments by physicians and will form the basis for regulatory submission to the FDA by the first half of 2025.
Spectral AI is a leading artificial intelligence (AI) company specializing in medical diagnostics.