REG - Spectral MD Holdings - Initiation of DFU Validation Study

Spectral MD HoldingsAnnouncement

13/06/2022 07:01

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RNS Number : 5304O  Spectral MD Holdings, Ltd.  13 June 2022

Spectral MD Holdings, Ltd

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

 

 Diabetic Foot Ulcer Clinical Validation Study Initiated

Validation study to assess up to 200 adult subjects with participation from
leading U.S. principal investigators

 

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 the start of its clinical validation study to support the
development of its Diabetic Foot Ulcer ("DFU") application for the DeepView®
Wound Imaging System. The proprietary technology combines multi-spectral
imaging and Artificial Intelligence (AI) to provide clinicians with an
immediate healing assessment for DFU, which enables clinicians to provide a
more accurate and timely diagnosis for therapeutic intervention.

 

The study will collect data from up to 200 adult subjects across seven
potential clinical sites to further develop DeepView®'s AI algorithm. Patient
enrollment for the validation study began this month and is expected to
complete in November 2022.

 

Building upon promising results from the clinical training study, where the
current diagnostic accuracy is 81%, the data collected from the validation
study will be used to bolster the Company's existing clinical database of DFU
images and physiologic information to train and improve the DeepView® AI
algorithm. Additionally, the validation study will collect data from a broader
population set of up to 200 subjects to increase geographic and ethnic
variability. Importantly, data collected will support the Company as it
prepares FDA and CE mark submissions for DeepView®'s DFU indication, planned
in 2023.

 

Participating investigators include: Dr. Alisha Oropallo, MD, Director of
Comprehensive Wound Healing Center at Northwell Health; Dr. Brock Liden, DPM,
Podiatry Specialist at Circleville Foot & Ankle Center, LLC; and Dr.
Babajide Ogunllana, DPM, West Houston Foot and Ankle Center. Additional
clinical sites are being evaluated and will be incorporated into the
validation study in the near future.

 

Dr. Alisha Oropallo, M.D., FACS, FSVS, Director of Comprehensive Wound Healing
Center at Northwell Health and National Principal Investigator for the study,
commented: "For patients with diabetes, foot ulcers can impact their quality
of life and lead to complicated infections and potential amputation. I look
forward to participating in this study as DeepView® has significant potential
to improve the current standard of care, resulting in faster application of
advanced therapy, better wound healing and reduced overall hospital visits and
utilization."

 

Mary Regan, PhD, VP of Clinical Affairs at Spectral MD, said: "We are very
pleased to have initiated the Clinical Validation Study, the next critical
step towards the completion of development for the DFU application for
DeepView® Wound Imaging System. To obtain robust clinical data, the Spectral
MD team has selected leading wound care providers to advance and develop our
DeepView® Wound Imaging technology. I look forward to working with all
participating clinical sites to ensure high quality data and clinical
engagement."

 

Market Abuse Regulation (MAR) Disclosure

The information contained within this announcement is deemed by the Company to
constitute inside information as stipulated under the Market Abuse Regulations
(EU) No. 596/2014 as it forms part of UK domestic law by virtue of the
European Union (Withdrawal) Act 2018 ('MAR'). Upon the publication of this
announcement via Regulatory Information Service ('RIS'), this inside
information is now considered to be in the public domain.

 

 

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/Caroline Rowe (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 / Sam Allen                          Mob: +44 (0)7980 541 893 / +44 (0)7502 558 258

 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

 

About Diabetic Foot Ulcer

DFU is a severe chronic diabetic complication that consists of lesions in the
deep tissues associated with neurological disorders and peripheral vascular
disease in the lower limbs. It is the most frequently recognized, complex and
costly symptom of diabetes and can lead to limb amputation if left
undiagnosed, misdiagnosed or untreated. Due to U.S. reimbursement rules,
physicians are currently required to wait 30 days to designate a DFU as
non-healing before using advanced wound care therapies, resulting in higher
probability of infections, longer healing times and significant lifetime
medical costs for the patient. DeepView®'s early healing assessment for DFU
would provide a significant improvement to the current standard of care,
resulting in faster application of advanced therapy, better wound healing and
reduced overall hospital visits and utilization.

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