REG - Spectral MD Holdings - Clinical results presented at US Burn Conference

Spectral MD HoldingsAnnouncement

16/11/2021 07:05

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RNS Number : 4457S  Spectral MD Holdings, Ltd.  16 November 2021

16 November 2021

 

Spectral MD Holdings, Ltd.

("Spectral MD", the "Company" or the "Group")

 

Early results from clinical study presented at major U.S. burn conference

 

 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.

 

 For further information, please contact:

 Spectral MD Holdings, Ltd.                                                                          https://investors.spectralmd.com/ (https://investors.spectralmd.com/)
 Wensheng Fan, Chief Executive Officer                                                               via Walbrook PR

 SP Angel Corporate Finance LLP (Nominated Adviser and Joint Broker)                                 +44 (0) 20 3470 0470
 Stuart Gledhill/Caroline Rowe (Corporate Finance)

 Vadim Alexandre/Rob Rees (Sales and Corporate Broking)
 Stifel Nicolaus Europe Limited (Joint Broker)                                                       +44 (0) 20 7710 7600
 Charles Hoare / Ben Maddison / Will Palmer-Brown

 Walbrook PR Ltd (Media & Investor Relations)      +44 (0)20 7933 8780 or spectralMD@walbrookpr.com
 Paul McManus/Sam Allen                                                     +44 (0)79 8054 1893/ +44 (0)75 0255 8258

 Louis Ashe-Jepson                                                          +44 (0) 7747 515393

 

 

About Spectral MD:
 

 

Using its DeepView® Wound Imaging Solution, an internally developed AI
technology and multispectral imaging solution that has received FDA
Breakthrough Designation for the burn indication, Spectral MD is able to
distinguish between non-healing and healing human tissue invisible to the
naked eye. Spectral MD currently is able to provide 'Day One' healing
assessments for burn wounds and diabetic foot ulcers with other applications
being explored.

 

Spectral MD has to date received substantial support from the U.S. government
with contracts from institutions such as Biomedical Advanced Research and
Development Authority, National Science Foundation, National Institute of
Health and Defense Health Agency in support of the burn application for its
DeepView® solution, with total grant funding received to date from all of
these organizations of over $93 million, including $40.5 million received in
2021.  This grant funding is non-dilutive to our shareholders and the Company
believes it validates the important nature of our mission and technology. The
Company leverages this funding to support R&D efforts that are applicable
to burn, DFU and potentially other indications where DeepView can play an
important role in Day 1 wound healing assessment.

 

The Company has two principal trading subsidiaries, Spectral MD, Inc. and
Spectral MD UK Limited.

 

DeepView®

DeepView(®) is a predictive analytics platform that integrates proprietary
AI algorithms and advanced optical technology for wound healing predictions.
It is non-invasive, non-radiation, non-laser and does not require the use of
injectable dye. This integration can be characterised into four distinct
components: DeepView(®) imaging, data extraction, AI model building and AI
wound healing prediction.

·    The DeepView(®) imaging technology consists of patented,
proprietary, multi-spectral optics and sensors that can classify wound tissue
physiology and capture the viability of various biomarkers within the skin.
The imaging technology extracts appropriate clinical data, processes the
image, and displays a comparison of the original image next to an image with a
colour overlay of the non-healing portions of the wound. The image acquisition
takes 0.2 seconds, and the output takes approximately 20 to 25 seconds.

 

·    The DeepView(®) data extraction consists of proprietary optics that
are able to collect millions of data points from each raw image. This
information is then used to build and continually improve the AI model, which
is trained and tested against a proprietary database of more than 66.7 billion
pixels with an ever-growing input of clinically validated data points.

 

·    The AI algorithm then produces a predictive wound healing assessment
in the form of an objective, accurate, and immediate binary wound healing
prediction. This prediction is graphically represented to the clinician
through a coloured overlay of the original image that annotates the
non-healing portion of the wound.

DeepView(®) is designed to allow clinicians to make a more accurate, timely
and informed decision regarding the treatment of the patient's wound. In the
case of DFUs, a non-healing assessment would provide the clinician with the
appropriate justification to use an advanced wound care therapy on 'Day One'
as opposed to waiting 30 days and potentially losing the patient to lack of
patient follow-up or risking patient noncompliance with standard wound
therapy. For burn wounds, the clinician can make an immediate and objective
determination to identify appropriate candidates for surgery as well as
determining what specific areas of the burn wound will require skin
grafting. DeepView(®) 's current accuracy for determining the healing
potential of burn wounds is 92 percent in adults and 88 percent in children,
compared with current physician accuracy of 50 to 70 percent. The current
clinical accuracy of DeepView(®) is 83 percent for DFUs. Both of these
accuracy percentages are expected to increase with additional R&D efforts,
including clinical studies.

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