Business
Spectral AI Surpasses 90% of Pediatric Enrollment Target in Burn Centers for Pivotal U.S. Burn Study
DALLAS, June 27, 2024 (GLOBE NEWSWIRE) -- Spectral AI, Inc. (Nasdaq: MDAI) (“Spectral AI” or the “Company”), an artificial intelligence (AI) company focused
About this update from Spectral Ai, Inc.
[{"type":"text","content":"DALLAS, June 27, 2024 (GLOBE NEWSWIRE) -- Spectral AI, Inc. (Nasdaq: MDAI) (“Spectral AI” or the “Company”), an artificial intelligence (AI) company focused on medical diagnostics for faster and more accurate treatment decisions in wound care, today announced that it has surpassed 90% of the enrollment target for pediatric patients at burn centers for its 2024 pivotal study designed to validate the AI-driven algorithm used by its DeepView™ System for its burn indication. “We are excited with the progress on enrollment of pediatric subjects, which has exceeded our expectations given the difficulties normally experienced in trials for this age group,” said Peter M. Carlson, CEO of Spectral AI. “We continue to enroll adult and pediatric subjects at both burn centers and emergency departments for our 2024 pivotal study.” This pivotal study is scheduled to be completed in the fourth quarter of 2024 and is expected to be the final clinical trial before the Company seeks FDA approval of its DeepView™ System for burn indication in 2025. For both adults and children, an accurate wound assessment is critical in determining the appropriate treatment protocol. However, the assessment of pediatric patients in comparison to adults poses distinct challenges. Pediatric skin is thinner and contains less subcutaneous fat than that of an adult, making it more challenging to assess the depth of the burn injury, and systemic responses to a burn injury differ from those of an adult patient. The age of the patient, their communication skills, and stage of development also serve as differentiating factors when treating a child. “More than 100,000 children are admitted to a hospital or treated in an emergency department for burn injuries each year,” Mr. Carlson noted. “The type, scope, and manner of care that must be delivered to children underscores our belief that empowering clinicians to deliver an immediate, accurate assessment of pediatric burn wounds is of critical importance.” Spectral AI’s DeepView™ System utilizes proprietary multispectral imaging, trained and tested against a proprietary database of more than 340 billion clinically validated data points to distinguish between healthy and damaged tissue. The DeepView™ System can be used immediately upon a child’s arrival to the emergency department or burn center, providing immediate and accura...