REG - Spectral MD Holdings - EU Clinical Study Initiated

Spectral MD HoldingsAnnouncement

21/02/2023 07:00

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RNS Number : 5050Q  Spectral MD Holdings, Ltd.  21 February 2023

 

Spectral MD Holdings, Ltd

("Spectral MD" or the "Company")

 

EU Diabetic Foot Ulcer Clinical Study Initiated in Ireland

Data from the study to support regulatory submissions on track for 2023

Participation from distinguished EU principal investigators provides
significant endorsement for DeepView™

 

LONDON, U.K. AND DALLAS, TX, U.S -Spectral MD Holdings, Ltd. (AIM: SMD), a
predictive analytics company with proprietary AI algorithms and optical
technology for faster and more accurate treatment decisions in wound care,
announces the initiation of its EU clinical study to support the development
and regulatory submission of its Diabetic Foot Ulcer (DFU) application for the
Company's DeepView™ technology.

 

The Company has partnered with the Royal College of Surgeons in Ireland's
(RCSI) Skin Wounds and Trauma (SWaT) Research Centre, Prof. Zena Moore,
Director; and Prof. Declan Patton, Deputy Director, at RCSI University of
Medicine and Health Sciences, to execute the clinical study with Prof. John
McDermott (Chief Clinical Investigator) and Prof. Seamus Sreenan (Sub
Investigator), both of Connolly Hospital, and RCSI in Dublin, Ireland.

 

The EU Wound Assessment Using Spectral Imaging clinical study will collect
data from DFU patients monitored up to 12 weeks. The intention of the clinical
study is to further develop the DeepView AI®-DFU algorithm and support the
Company's 2023 regulatory submissions for UK CA, US FDA, and EU CE Mark.

 

Chronic wounds, such as DFU, affect 9.1 to 26.1 million patients globally each
year, and are the most frequently recognized, complex and costly symptom of
diabetes. Globally, 70% of DFUs recur within three years, representing a
significant health and economic burden to both patients and hospital systems.
Additionally, undiagnosed, misdiagnosed, or untreated DFUs commonly lead to
limb amputation and poor patient outcomes.

 

There is currently no diagnostic tool available for early wound healing
diagnosis, with physicians required to wait 30 days to designate a DFU as
non-healing before using advanced wound care therapies. Early and accurate
diagnosis of non-healing DFUs would considerably improve patient quality of
life and DFU healing rates. The Company announced in January 2023
(https://www.londonstockexchange.com/news-article/SMD/dfu-clinical-study-interim-results-burn-update/15799946)
interim results for DeepView AI®-DFU's day-one prediction of 86% diagnostic
accuracy of a 50% DFU size reduction by week four from five clinical study
sites in the US, and this EU clinical study data will enhance its clinical
database and strengthen the regulatory and clinical pathways.

 

Prof. Zena Moore and Prof. Declan Patton of the RCSI SWaT Research Centre
jointly commented: "With our clinical partners we are committed to better
wound care diagnostics and treatment for patients. This study will ensure we
continue to be at the cutting edge of clinical wound care research that makes
a difference to people with non-healing ulcers. Working with Spectral MD also
enhances our place at the forefront of medical device research and translation
for everyday wound care practice."

 

Wensheng Fan, Chief Executive Officer of Spectral MD, stated: "The initiation
of the EU study is an important milestone for the Company. We are delighted by
this industry-academic partnership led by a group of eminent clinicians and
clinical researchers, which we see as a significant industry-wide endorsement
for DeepView™. Data collected from this collaboration will strengthen the
predictive capability of the DeepView™ technology for early stage wound
assessment."

 

Prof. Fergal O'Brien, Deputy Vice-Chancellor for Research and Innovation at
RCSI, commented: "By bringing together the research expertise of the SWaT
Research Centre at RCSI with the advanced technological capabilities of
Spectral MD, this study is driving forward wound care technology development
to address a significant unmet need by improving diagnostic imaging and
quantitative diagnosis and ultimately patient outcomes."

 

 

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

 

About RCSI University of Medicine and Health Sciences

RCSI University of Medicine and Health Sciences is a world-leading university
for Good Health and Well-being. Ranked in the world top 50 for its
contribution to UN Sustainable Development Goal 3 in the Times Higher
Education Impact Rankings 2022, it is exclusively focused on education and
research to drive improvements in human health worldwide.

 

RCSI is an international not-for-profit university, headquartered in Dublin.
It is among the top 250 universities worldwide in the World University
Rankings (2023). RCSI has been awarded Athena Swan Bronze accreditation for
positive gender practice in higher education.

 

Visit the RCSI MyHealth Expert Directory
(https://www.rcsi.com/dublin/news-and-events/expert-directory) to find the
details of our experts across a range of healthcare issues and concerns.
Recognising their responsibility to share their knowledge and discoveries to
empower people with information that leads them to better health, these
clinicians and researchers are willing to engage with the media in their area
of expertise.

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