Spectral AI Achieves 100% Pediatric Enrollment in Burn Centers for Pivotal U.S. Burn Study
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.
- 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.
- None.
Insights
Pediatric enrollment completion in Spectral AI's pivotal burn study marks a significant milestone for the company's DeepView™ System. This system employs advanced multispectral imaging to assess burn wounds quickly and accurately, a vital capability given the severity of burn injuries. Achieving 100% enrollment within just 6 months is noteworthy, reflecting both the urgency and the clinical community's support for this innovation. The successful enrollment of pediatric patients further underscores the study's potential to set new standards in burn care, especially for vulnerable populations such as children.
Critically, the timely enrollment achievement indicates strong operational capabilities, which may reassure investors about the company's ability to meet future timelines, particularly the planned FDA approval in 2025. It's important to note that the DeepView™ System's non-invasive nature and its cart-based mobility enhance its applicability in emergency settings, promising better patient outcomes through quicker diagnostic processes.
For retail investors, this news suggests a robust clinical pathway and operational efficiency, both of which are positive indicators of the company’s future performance and potential market adoption of their technology.
Spectral AI's announcement of completing pediatric enrollment in its pivotal burn study is promising from a financial standpoint. Reaching this milestone ahead of schedule can be seen as a positive indicator for the company’s project management skills and its ability to meet critical deadlines, which is important for investor confidence. This progress also suggests that the company is on track to achieve its next major milestone: FDA approval in 2025. Successful FDA approval would significantly enhance the company's commercial prospects, potentially driving substantial revenue growth.
Investors should also consider the market potential of the DeepView™ System. If it meets clinical and regulatory requirements, the system could address a significant unmet need in burn care, providing a non-invasive, immediate assessment tool that improves clinical decision-making. The pediatric focus adds another layer of market appeal, as effective pediatric care technologies often receive strong support from both the medical community and healthcare payers.
While the current completion of pediatric enrollment is a critical step forward, investors should remain vigilant about subsequent phases of the study and any additional announcements that might impact the timeline for FDA approval and market launch.
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
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