Spectral AI Surpasses Halfway Point in U.S. Burn Study Enrollment

Spectral AI Inc. has surpassed 50% clinical trial site enrollment at burn centers for its 2024 pivotal study, designed to validate the algorithm used by its DeepView System for burn indication. This pivotal study—which is targeting a 240-patient enrollment, including both adults and children at multiple U.S. burn centers and emergency departments—is expected to be the final clinical trial before seeking U.S. Food and Drug Administration approval next year.

“We are committed to advancing burn care through the implementation of innovative technologies and rigorous clinical research. Our objective is to deliver to healthcare providers the cutting-edge tools they need to enhance their ability to immediately and accurately assess a burn wound’s healing potential,” Spectral AI Vice President of Medical Affairs Mary Regan said. “We are enthusiastic about the achievement of this enrollment milestone as we aim to demonstrate DeepView’s AI effectiveness in providing accurate wound assessments and timely clinical decision-making for burn injuries.”
 
The completion of the pivotal study will address two primary objectives. First, the trial will validate the standalone performance of the DeepView System’s algorithm on an independent dataset, further solidifying its objective utility in clinical practice. The study also will compare the efficacy of the DeepView System’s finalized image processing algorithm against existing clinician assessment, as quantified by clinician judgment annotations.
 
“As clinicians, our goal is to provide the best possible care for burn patients, utilizing the latest medical advancements and techniques,” said Dr. Kathleen Romanowski, principal investigator at one of the clinical trial sites, the UC Davis Firefighters Burn Institute Regional Burn Center. “DeepView’s technology has the potential to significantly enhance our ability to assess burn wounds accurately, leading to improved patient outcomes and quality of life.”
 
The company’s DeepView System image processing algorithm utilizes multispectral imaging, trained and tested against a proprietary database of more than 340 billion clinically validated data points, to deliver a rapid and objective assessment that aids healthcare providers in assessing the healing potential of a burn wound. The U.S. pivotal study is currently enrolling patients at various U.S. burn centers, with principal investigators overseeing the research.
 
The burn centers currently enrolled in the company’s U.S. pivotal study includes Arizona Burn Center Valleywise Health, VCU Health Evans-Haynes Burn Center, St. Christopher’s Stuart J. Hulnick Burn Center, UC Davis Firefighters Burn Institute Regional Burn Center, Shriners Children’s Northern California Neil Reitman Pediatric Burn Institute, UW Harborview Regional Burn Center, University of Kansas Burnett Burn Center, North Carolina Jaycee Burn Center, SUNY Stony Brook Burn Center, Akron Children’s Hospital Burn Institute, University of Iowa Burn Treatment Center, and The Ohio State Comprehensive Burn Center.   

Spectral AI Inc. is a Dallas-based predictive artificial intelligence 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, a predictive 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, DeepView is expected to provide faster and more accurate treatment insight towards value care by improving patient outcomes and reducing healthcare costs.