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Spectral AI Completes Burn Center Enrollment for U.S. Burn Pivotal Study
Milestone Achievement Advances Commercialization Timeline for DeepView™ System for Burn Indication DALLAS, Aug. 27, 2024 (GLOBE NEWSWIRE) -- Spectral AI, Inc.
About this update from Spectral Ai, Inc.
[{"type":"text","content":"Milestone Achievement Advances Commercialization Timeline for DeepView™ System for Burn Indication\nDALLAS, Aug. 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 the completion of adult and pediatric patient enrollment at U.S. burn centers for its U.S. Burn Pivotal Study. One of the largest domestic burn studies ever conducted, the U.S. Burn Pivotal Study is designed to validate the AI-driven algorithm used by the Company’s DeepView™ System for burn indication. Using data from these burn center patients, the Company will pursue a De Novo classification from the U.S. Food and Drug Administration (“FDA”) for use of the DeepView™ System in burn centers and expects to submit the request in the second quarter of 2025. “We met our burn center enrollment goal much sooner than anticipated due to the dedication of our team and the support of study participants,” said Peter M. Carlson, Chief Executive Officer of Spectral AI. “This milestone achievement will allow us to begin data analysis and advances our product commercialization timeline,” Carlson added. Spectral AI's DeepView™ System for burn indication is a predictive medical device that assesses the healing potential of burns by combining multi-spectral imaging with an AI-driven algorithm trained and tested against a proprietary database of more than 340 billion clinically validated data points. By distinguishing between healing and non-healing tissue, the DeepView™ System provides an immediate and binary prediction of wound healing on Day One that can support clinical decision-making regarding next step treatment plans. The DeepView™ System has demonstrated superior accuracy in assessing burn wounds compared to the current standard of care. “I am proud of the incredible work by our investigators, their dedicated staff and most critically study enrolees,” stated Dr. Jeffrey Carter, MD, Principal Investigator of the Pivotal Study. “We enrolled 160 patients in less than eight months, in what we believe to be one of the fastest enrolling burn studies ever completed in the U.S. The results will be used by our data science team and our panel of burn experts to complete years of work and bring t...