Spectral AI Inc (NASDAQ:MDAI) announced it surpassed 90% of its enrollment target for pediatric patients at burn centers for its late-stage study evaluating its AI-driven DeepView System.
Shares of Spectral AI moved higher on the news, adding 5.4% at US$1.77 in the early afternoon on Thursday.
The company’s DeepView System utilizes proprietary multispectral imaging to distinguish between healthy and damaged tissue and can be used upon a child’s arrival at the emergency department or burn center to provide 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, reducing any potential trauma associated with moving an injured child, the company highlighted.
“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,” Spectral AI CEO Peter Carlson commented.
“We continue to enroll adult and pediatric subjects at both burn centers and emergency departments for our 2024 pivotal study.”
He noted that more than 100,000 children are admitted to a hospital or treated in an emergency department for burn injuries each year.
“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,” Carlson said.
The pivotal study is expected to be completed in the fourth quarter of 2024.
It is also expected to be the final trial of the DeepView System for burn indications before the company seeks FDA approval of the device in 2025.
- Updated with share price movement -