Spectral AI (NASDAQ: MDAI) stock surged almost 3% on Friday after the company initiated the enrollment process for a pivotal study to validate DeepView AI® for burn injuries.
Spectral AI (MDAI) has announced the enrollment of the first patient in a pivotal study that aims 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. It will be conducted in burn centers and emergency departments across the US, enrolling adult and pediatric patients.
Dr. Jeffrey C. Carter, MD, FACS, the lead investigator for the study, expressed enthusiasm about the beginning of enrollment, stating,
“We are excited to begin enrollment in this pivotal study implementing the DeepView system in clinical sites across the United States. 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.”
He added,
“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.”
Niko Pagoulatos, Ph.D., Chief Operating Officer of Spectral AI, said,
“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.”
Spectral AI (NASDAQ: MDAI) stock closed at $2.62, marking a 2.74% increase compared to the closing price of January 11.
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