Spectral AI Achieves 100% Pediatric Enrollment in Burn Centers for Pivotal U.S. Burn Study
Rhea-AI Summary
Spectral AI has achieved full pediatric patient enrollment at burn centers for its 2024 pivotal U.S. burn study, aimed at validating its DeepView™ System's AI-driven algorithm for burn indications. This study, set to conclude in Q4 2024, is the final step before seeking FDA approval in 2025.
The company met enrollment goals in just six months, demonstrating strong support from investigators. Spectral AI continues to enroll pediatric and adult patients through emergency departments to further validate its DeepView™ algorithm.
The DeepView™ System, utilizing proprietary multispectral imaging and a vast, clinically validated database, aims to provide immediate, accurate assessments of pediatric burn wounds. This non-invasive, cart-based system can be used directly at the patient’s location, enhancing early treatment decisions and potentially improving patient outcomes.
Positive
- Achieved 100% pediatric patient enrollment in just six months.
- Pivotal U.S. burn study scheduled to complete in Q4 2024, leading to FDA approval in 2025.
- Strong support from investigators for the DeepView™ System.
- Continued patient enrollment to enrich and validate the AI algorithm.
Negative
- None.
News Market Reaction
On the day this news was published, MDAI declined 7.18%, reflecting a notable negative market reaction.
Data tracked by StockTitan Argus on the day of publication.
DALLAS, July 02, 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 achieved
This pivotal study is scheduled to be completed in the fourth quarter of 2024 and is the final clinical trial before the Company seeks FDA approval of its DeepView™ System for burn indication in 2025.
“Due to the investigators’ enthusiasm and the potential to change burn care, we have met pediatric enrollment goals for burn centers at an unprecedented 6 months,” said Jeffrey E. Carter, MD, FACS, Lead Investigator. “We are continuing to enroll adult patients and pediatric patients through emergency departments to enrich and validate the DeepView algorithm.”
“We are grateful to our team for their continuing hard work and dedication in advancing this important clinical trial,” said Peter M. Carlson, CEO of Spectral AI. “Burn wounds can be devastating, especially for children who are particularly vulnerable to these injuries. Empowering clinicians to deliver an immediate, accurate assessment of pediatric burn wounds is of critical importance. We believe that the DeepView™ System, powered by our propriety AI-driven algorithm, has the potential to change the standard of burn care by supporting early treatment decisions that can lead to improved patient outcomes.”
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 accurate wound assessments in support of timely clinical decision-making for burn injuries. The procedure is non-invasive and because it is cart-based, the DeepView™ System can be brought to the patient, thus alleviating any potential trauma associated with moving an injured child.
About Spectral AI
Spectral AI, Inc. is a Dallas-based predictive AI 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. The DeepView System is 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 and a goal to change the current standard of care, the DeepView System is expected to provide faster and more accurate treatment insight towards value care by improving patient outcomes and reducing healthcare costs. For more information about the DeepView System, visit www.spectral-ai.com.
Forward Looking Statements
Certain statements made in this release are “forward looking statements” within the meaning of the “safe harbor” provisions of the United States Private Securities Litigation Reform Act of 1995, including statements regarding the Company’s strategy, plans, objectives, initiatives and financial outlook. When used in this press release, the words “estimates,” “projected,” “expects,” “anticipates,” “forecasts,” “plans,” “intends,” “believes,” “seeks,” “may,” “will,” “should,” “future,” “propose” and variations of these words or similar expressions (or the negative versions of such words or expressions) are intended to identify forward-looking statements.
These forward-looking statements are not guarantees of future performance, conditions or results, and involve a number of known and unknown risks, uncertainties, assumptions and other important factors, many of which are outside Company’s control, that could cause actual results or outcomes to differ materially from those discussed in the forward-looking statements. As such, readers are cautioned not to place undue reliance on any forward-looking statements.
Investors should carefully consider the foregoing factors and the other risks and uncertainties described in the “Risk Factors” sections of the Company’s filings with the SEC, including the Registration Statement and the other documents filed by the Company. These filings identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements.
Investors:
The Equity Group
Devin Sullivan
Managing Director
dsullivan@equityny.com
Conor Rodriguez
Analyst
crodriguez@equityny.com
FAQ
What milestone did Spectral AI achieve for its 2024 pivotal U.S. burn study?
When is Spectral AI's pivotal study expected to conclude?
What is the significance of Spectral AI’s DeepView™ System?
When is Spectral AI planning to seek FDA approval for the DeepView™ System?
How does the DeepView™ System work?
