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The following release has just been issued. The positive is that things are moving forwards, but not sure this will do anything for the price in the short term. A year plus wait to confirm what will be hopefully very positive results.
DALLAS, Jan. 11, 2024 (GLOBE NEWSWIRE) -- Spectral AI, Inc. (NASD:MDAI)
(“Spectral AI” or the “Company”), an artificial intelligence (AI)
company focused on medical diagnostics for faster and more accurate treatment
decisions in clinical wound care, announces the enrollment of the first
patient in the pivotal study to validate DeepView AI(®) using its
proprietary imaging technology for burn size and healing assessment. This
pivotal study is expected to be the final clinical trial before seeking FDA
marketing authorization for the burn indication in 2025 and will be conducted
in burn centers and emergency departments across the US, enrolling both adults
and pediatric patients.
Niko Pagoulatos, Ph.D., Chief Operating Officer of the Company stated: “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.”
“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,”
said Jeffrey C. Carter, MD, FACS, the lead investigator for the study. “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.”
The data obtained in the study will be compared to assessment by physicians
and used for regulatory submission to the FDA by the first half of 2025.