REG - Spectral MD Holdings - U.S. Burn AI Training Study Enrollment Completed

Spectral MD HoldingsAnnouncement

27/03/2023 07:00

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RNS Number : 2067U  Spectral MD Holdings, Ltd.  27 March 2023

Spectral MD Holdings, Ltd

("Spectral MD" or the "Company")

 

U.S. Burn AI Clinical Training Study Enrollment Completed

Successful completion of clinical study enrollment paves way for next phase of
BARDA funding

Data used to finalize DeepView AI®-Burn algorithm

 

LONDON, U.K. AND DALLAS, TX, U.S. -Spectral MD Holdings, Ltd. (AIM: SMD), a
predictive analytics company with proprietary artificial intelligence (AI)
algorithms and optical technology for faster and more accurate treatment
decisions in wound care, announces the completion of enrollment for its U.S.
Burn AI Training Study ("Training Study") supported by the Biomedical Advanced
Research and Development Authority (BARDA), part of the Administration for
Strategic Preparedness and Response within the U.S. Department of Health and
Human Services.

 

The Company is using the data collected from adult and pediatric subjects
enrolled in the study to finalize the DeepView AI®-Burn algorithm and make
sample size determinations for its U.S. Burn AI Validation Study ("Validation
Study"), which is expected to start in H2 2023.

 

The Training Study was performed across 11 leading burn centers in the U.S.,
and was expanded in August 2022
(https://www.londonstockexchange.com/news-article/SMD/additional-8-2m-of-funding-from-barda/15604609)
with BARDA's support, to include additional pediatric sites and U.S. Emergency
Departments ("EDs"). Enrollment completion fulfills this phase of the
Company's contractual requirements with BARDA. The Company is aligning its
efforts to complete the necessary requirements for the upcoming Validation
Study.

 

The Validation Study will generate an independent dataset with subjects
enrolled across different U.S. study sites from the Training Study. This is a
requirement for the U.S. Food and Drug Administration (FDA) to remove bias
from the results ahead of the Company's DeepView AI®-Burn FDA regulatory
submission, planned in 2024.

 

Wensheng Fan, Chief Executive Officer of Spectral MD, stated: "The completion
of enrollment in our Burn AI Training Study represents a significant milestone
for Spectral MD, as it meets our contractual obligations with BARDA, paving
the way for the final stage of clinical development for DeepView AI®-Burn.
With BARDA's invaluable support, we anticipate initiating our Burn AI
Validation Study in the second half of 2023, and we remain committed to our
partnership to deliver a non-invasive imaging platform for the U.S. government
that enables physicians to accurately and instantaneously assess the severity
of burns in mass-casualty events."

 

Dr. Jeffrey Carter, Chief Medical Consultant, and National Principal
Investigator for the Training Study, said: "Today's milestone represents
another exciting step forward as we advance the development of
the DeepView™ technology for burn wound healing assessment. We
successfully reached study enrollment completion on schedule, in our largest
clinical trial to date, reflecting the high interest from patients and
physicians in a 'Day One' burn wound healing assessment."

 

Currently, there are only 250 burn surgeons in the U.S., or 0.3% of the 84,000
members of the American College of Surgeons. The decline in burn experts,
education, and experience has left large regions of the U.S. without the
ability to accurately assess burn wound healing or burn wound size, resulting
in unnecessary transfers from EDs to burn centers, and unnecessary days in the
hospital while surgeons reassess burn wounds for surgery. DeepView™ uniquely
addresses these challenges by aiding clinicians in accurately assessing burn
wound healing potential on 'Day One'. DeepView AI®-Burn currently has a wound
healing diagnostic accuracy of 92%, significantly above physician clinical
judgement accuracy of between 50-75%.

 

This project has been supported in whole or in part with federal funds from
the Department of Health and Human Services; Administration for Strategic
Preparedness and Response; Biomedical Advanced Research and Development
Authority (BARDA), under contract number 75A50119C00033.

 

For further information please contact:

 

 Spectral MD Holdings, Ltd.                        investors.spectralmd.com
 Wensheng Fan, Chief Executive Officer             via Walbrook PR
 Nils Windler, Chief Financial Officer

 SP Angel Corporate Finance LLP (NOMAD and Joint Broker)                                             Tel: +44 (0)20 3470 0470
 Stuart Gledhill/Harry Davies-Ball (Corporate Finance)

 Vadim Alexandre/Rob Rees (Sales & Broking)

 Stifel Nicolaus Europe Limited (Joint Broker)     Tel: +44 (0)20 7710 7600

 Charles Hoare / Ben Maddison / Nick Harland /

 Will Palmer-Brown

 Walbrook PR Ltd (Media & Investor Relations)      Tel: +44 (0)20 7933 8780 or spectralMD@walbrookpr.com
 Paul McManus / Louis Ashe-Jepson                  Mob: +44 (0)7980 541 893 / +44 (0)7747 515 393

 Alice Woodings                                     +44 (0)7407 804 654

 

About Spectral MD:
 

We are a dedicated team of forward-thinkers striving to revolutionize the
management of wound care by "Seeing the Unknown" ® with our DeepView(®)
Wound Imaging System.

www.spectralmd.com

info@spectralmd.com

 

 

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