Spectral AI Surpasses 90% of Pediatric Enrollment Target in Burn Centers for Pivotal U.S. Burn Study
Spectral AI (Nasdaq: MDAI) announced it has surpassed 90% of its pediatric enrollment target in burn centers for its 2024 pivotal study to validate the AI-driven DeepView™ System. This study, set to be completed in Q4 2024, aims for FDA approval in 2025. The DeepView™ System uses proprietary multispectral imaging and a database of over 340 billion data points to accurately assess burn depth in children, who face unique challenges in burn treatment due to thinner skin and different systemic responses. Spectral AI's system aims to provide immediate, non-invasive assessments, reducing stress and uncertainty for pediatric burn patients and their families.
- Surpassed 90% pediatric enrollment target for pivotal study.
- Pivotal study to be completed in Q4 2024, aiming for 2025 FDA approval.
- DeepView™ System utilizes a database of over 340 billion clinically validated data points.
- Non-invasive, cart-based system reduces trauma for injured children.
- Challenges in assessing burn depth in pediatric patients due to thinner skin and different systemic responses.
Insights
Spectral AI's progress in the pivotal U.S. burn study, especially surpassing the
From a clinical perspective, the DeepView™ System’s AI-driven algorithm aims to provide immediate and accurate wound assessments. This could revolutionize burn care by reducing the time to treatment decision, which is important for optimal recovery outcomes. The non-invasive nature of the system, coupled with its portability, addresses significant hurdles in current burn diagnosis practices, particularly in the pediatric segment where moving an injured child can be traumatic.
Furthermore, the scheduled completion of the study in the fourth quarter of 2024 and anticipated FDA submission in 2025 align with industry timelines for clinical validation and regulatory approval. The system's ability to distinguish between healthy and damaged tissue using multispectral imaging could set new standards in burn care.
In summary, this progress signals a potential breakthrough in medical diagnostics, offering a tool that enhances clinical decision-making through advanced technology. It combines the need for accuracy, speed and patient comfort, addressing a critical gap in pediatric burn treatment.
Spectral AI's update on its pivotal study is positive news for investors, primarily because it demonstrates both progress and momentum towards FDA approval for the DeepView™ System. The company’s ability to surpass the
Looking at the short-term implications, this development could bolster investor confidence, potentially stabilizing or even increasing the stock price. The stock may also attract more attention from institutional investors who look for companies making tangible progress in clinical trials. Furthermore, hitting these milestones makes the firm a more attractive acquisition target for larger medical device companies looking to expand their AI capabilities or enter the pediatric market.
In the long-term, successful FDA approval and market entry of the DeepView™ System could mean substantial revenue growth for Spectral AI. The pediatric burn care market, as indicated by the CEO’s statement regarding the high incidence of pediatric burn injuries, represents a significant market opportunity. Being one of the first AI-driven diagnostic tools to achieve FDA approval could position Spectral AI as a leader in this niche, offering substantial competitive advantages.
It’s also important to consider the potential drawbacks and risks. FDA approval processes are inherently unpredictable and any delays could affect the anticipated timelines and investor sentiment. Additionally, post-approval, the company will need to navigate the complexities of market adoption, reimbursement policies and competitive responses.
Overall, the progress in the pivotal study is a strong indicator of Spectral AI’s potential and reinforces their strategic focus on addressing critical healthcare challenges with innovative solutions.
DALLAS, June 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 that it has surpassed
“We are excited with the progress on enrollment of pediatric subjects, which has exceeded our expectations given the difficulties normally experienced in trials for this age group,” said Peter M. Carlson, CEO of Spectral AI. “We continue to enroll adult and pediatric subjects at both burn centers and emergency departments for our 2024 pivotal study.”
This pivotal study is scheduled to be completed in the fourth quarter of 2024 and is expected to be the final clinical trial before the Company seeks FDA approval of its DeepView™ System for burn indication in 2025.
For both adults and children, an accurate wound assessment is critical in determining the appropriate treatment protocol. However, the assessment of pediatric patients in comparison to adults poses distinct challenges. Pediatric skin is thinner and contains less subcutaneous fat than that of an adult, making it more challenging to assess the depth of the burn injury, and systemic responses to a burn injury differ from those of an adult patient. The age of the patient, their communication skills, and stage of development also serve as differentiating factors when treating a child.
“More than 100,000 children are admitted to a hospital or treated in an emergency department for burn injuries each year,” Mr. Carlson noted. “The type, scope, and manner of care that must be delivered to children underscores our belief that empowering clinicians to deliver an immediate, accurate assessment of pediatric burn wounds is of critical importance.”
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.
“The time surrounding a burn injury is often stressful for children and their families. It is a time of great uncertainty,” said Dr. Kathleen Romanowski, Principal Investigator at one of the clinical trial sites, Shriners Children's Northern California Neil Reitman Pediatric Burn Institute. “We anticipate Spectral AI’s DeepView™ System will allow practitioners to eliminate some of that uncertainty through early identification of burn depth and the potential need for surgical treatment.”
The pivotal clinical study is designed to: validate the standalone performance of the DeepView™ System’s AI-driven algorithm on an independent dataset, further solidifying its objective utility in clinical practice and compare the efficacy of the DeepView™ System's finalized image processing algorithm against existing clinician assessment, as quantified by clinician judgment annotations.
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.
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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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