Spectral AI Inc (NASDAQ:MDAI) announced a significant milestone in its US Burn Pivotal Study with 25% of patient enrollment completed in Emergency Departments (EDs).
The study aims to validate the AI-powered DeepView System for burn indications, specifically its ability to assess burn severity and healing potential through its DeepView AI-Burn algorithm.
Spectral has also expanded the study to two new clinical trial sites: MedStar Washington Hospital Center in Washington, DC, led by Principal Investigator Dr. Shawn Tejiram, and the University of Utah, under the direction of Principal Investigator Dr. Giavonni Lewis, bringing the total number of EDs participating in the study to 11.
"We are continuing to build momentum and advance towards achieving our ED enrollment goals," said Peter Carlson, CEO of Spectral AI.
"Access to specialized burn treatment in the United States has declined significantly, resulting in an increasing number of front-line ED clinicians assuming the initial responsibility of assessing the severity and healing trajectory of a burn wound.”
Earlier, Spectral AI successfully completed adult and pediatric patient enrollment at US burn centers. The data gathered from these patients will support the company's planned De Novo submission to the US Food and Drug Administration (FDA), requesting classification of DeepView AI-Burn as a Class II medical device. The company expects to submit this request in the second quarter of 2025.
“We believe that the use of DeepView AI-Burn can deliver burn expert-level clinical support to a busy, oftentimes chaotic, ED setting,” Carlson added.
The DeepView System is designed to differentiate between healing and non-healing tissue to assist in faster, more accurate treatment decisions.