Business
Spectral AI Announces 2024 Second Quarter Financial Results
Second Quarter Revenue Totals $7.5 Million Total Enrollment Exceeds 85% for Burn Center Pivotal U.S. Clinical Trial Q2 2024 Overview Research & Development
About this update from Spectral Ai, Inc.
[{"type":"text","content":"Second Quarter Revenue Totals $7.5 Million Total Enrollment Exceeds 85% for Burn Center Pivotal U.S. Clinical Trial Q2 2024 Overview Research & Development Revenue of $7.5 MillionCash Position of $6.9 MillionOn Track to Generate First Commercial Revenues in the U.K. Later this YearBurn Pivotal Study Nearing Completion Paving the Way for U.S. FDA Submission in Early 2025Announced Collaboration with PolyNovo Ltd. Providing Introduction to Australian MarketContinued Progress in Handheld Burn Wound Diagnostic TechnologyAdded to Russell Microcap® Index effective July 1, 2024 DALLAS, Aug. 12, 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 financial results for the second quarter ended June 30, 2024 (“Q2 2024”) and provided an update on its ongoing business activities. “This is one of the most exciting and consequential periods in our history, and I am proud to see the teams advancing our proprietary, AI-driven DeepView™ System for burn indication (“DeepView AI- Burn”) along multiple fronts, including clinical, developmental and commercial,” said Peter M. Carlson, CEO of Spectral AI. “The upcoming completion of enrollment at burn centers for our U.S. Burn Pivotal Study, continued development of both our cart-based device and the handheld diagnostic tool, and anticipation of our first commercial revenues in the U.K. later this year validate our vison and reinforce our strategic imperatives.” CLINCIAL TRIAL UPDATES Patient enrollment for the 2024 U.S. Burn Pivotal Study continues to progress well at burn centers, where total enrollment now exceeds 85%. This pivotal study, which is designed to validate the AI-driven algorithm of DeepView AI-Burn, will be the final clinical trial before the Company seeks regulatory approval in 2025 and is one of the largest burn studies ever conducted in the United States.Building on this momentum, the Company will pursue a De Novo classification from the U.S. Food and Drug Administration (“FDA”) for DeepView AI-Burn for use in burn centers and expects to submit the request in the second quarter of 2025. A subsequent 510k application will be made for the use of DeepView AI-Burn in emergency departments after recei...