Spectral MD announce early results from clinical study

Accuracies of 92% and 88% in detection of severe thermal burn injury in adults and children, respectively

Article published in Journal of Burn Care and Research on histological burn depth research

LONDON, U.K. AND DALLAS, TX, U.S. Spectral MD Holdings, Ltd. (AIM: SMD), a predictive analytics company that develops proprietary AI algorithms and optical technology for faster and more accurate treatment decisions in wound care, announces that it has presented early clinical results from the Expanded Proof of Concept  multi-centre clinical study at three scientific presentations at Southern Region Burn Conference held from 4-7 November, 2021, in New Orleans, Louisiana.

The results of the first multi-center study using Spectral MD’s burn imaging technology include 124 adult and pediatric participants. In adult participants, the performance with cross-validation from the AI model for identification of non-healing burn regions showed 92% accuracy, an improvement on the previously reported accurarcy of 91% for  the DeepView® Wound Imaging Solution in early healing assessment of adults. In pediatric patients, the AI performance showed 88% accuracy, underlining how the technology is responding with significant reliability to variability in the study population.

Compared to the precise and early healing assessment of Spectral’s DeepView® Wound Imaging Solution for burn wounds, the current standard of care relies on physicians using a wait-and-see approach of up to 21 days to determine the need for surgery. This results in a higher probability of infections, additional costs, longer hospital stays and over-excision of viable skin.

The Southern Region Burn Conference is one of the largest scientific burn conferences held each year with hundreds in attendance. The titles of the presentations related to Spectral MD’s work and the presenters were as follows:

  • “Initial Experience Using Artificial Intelligence for the Assessment of Pediatric Burn Depth.” – Dr. James H. Holmes IV
  • “Iterative Refinement of a Histologic Algorithm for Burn Depth Categorization Based on 1142 Consecutive Burn Wound Biopsies.” – Dr. Herbert Phelan
  • “Rise of the (Learning) Machines: Artificial Intelligence for the Assessment of Adult Thermal Burns.” – Dr. Jeffrey Carter 

The Company also announces that a study publication has been published in the Journal of Burn Care and Research, written by Dr. Herbert Phelan, titled “Use of 816 Consecutive Burn Wound Biopsies to Inform a Histologic Algorithm for Burn Depth Categorization”. The study was originally presented at the 2021 American Burn Association Conference and details the years of work performed by Spectral MD and clinical colleagues to characterise burn depth using histologic parameters. The histologic methods being developed through this research are applied to the development of DeepView®’s AI algorithm for burn detection.

Wensheng Fan, Chief Executive Officer of Spectral MD, said: “The results not only demonstrate excellent AI performance metrics, they also show the technology is responding well to demographic and geographic variability in the study population. As such, we have already bolstered our infrastructure to facilitate expansion of the study to additional sites and have begun enrolling in a larger study to complete AI algorithm development.

“This is an important milestone for Spectral MD and begins an exciting period where we look to initiate a publication process concerning the results from our clinical studies in both the burn and DFU indications. We look forward to providing further updates from our clinical studies which detail the substantial improvement to the standard of care that DeepView® can deliver for burn and DFU patients.”

Jeffrey Carter, MD, Medical Director of University Medical Center New Orleans Burn Center, said: “This is an exciting time for Spectral MD and the burn community as we open new sites for the next study phase and begin to share the great results we have already established.”

Jeffrey Thatcher, Ph.D, Chief Scientist of Spectral MD, said: “This meeting marks the first time we present results from a multi-center study with the DeepView® burn assessment technology. This study, involving participants aged seven months and older, was critical toward our goal of understanding the use of this technology for both adults and children with burn injuries.

“We are also pleased to publish research by Spectral MD in the Journal of Burn Care and Research. The publication, written by Dr. Phelan, details a substantial period of histological research by the Company and its clinical colleagues into burn depth. The Journal is the official publication of the American Burn Association, and we look forward to contributing further research in the future.”

The presentation of the early clinical results from the multi-centre clinical study is an important milestone and represents the start of the Company’s publication process in relation to the results from its clinical studies in the burn and diabetic foot ulcer (“DFU”) indications. The funding and technical development of the DeepView burn assessment technology has been supported in whole by the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response under contract number 75A50119C00033.