Spectral receives UKCA authorisation for burn indication expected commercialisation second half 2024

Spectral AI, Inc. (Nasdaq: MDAI) (“Spectral AI” or the “Company”), an artificial intelligence (AI) company focused on medical diagnostics for faster and more accurate treatment decisions in wound care, has announced its predictive software DeepView AI-Burn has obtained the final stage of UK Conformity Assessed (UKCA) authorisation, for aiding in burn wound diagnosis in the UK.

“I am delighted to announce this achievement in our Company’s evolution. The completion of this milestone will allow us to sell our DeepViewTM System in the UK and we expect to swiftly deploy six devices in the UK for customer evaluation and to begin generating revenue in the second half of this year,” said Wensheng Fan, the Company’s Chief Executive Officer. “In addition, this regulatory authorisation opens up the ability to expand partnerships with regions such as the Middle East that recognise the UKCA authorisation.”

Revenue from commercialisation in the UK in 2024 represents an addition to the $28 million revenue guidance previously communicated by the Company.

The DeepView System wound imaging device uses AI-enabled algorithms analysing real-life patient wounds that assess clinically validated data points to distinguish between healthy and damaged tissue within seconds, unlike the current standard of care, which requires up to three to four weeks of evaluation.

The technology establishes a high level of accuracy, 92 per cent, in discerning whether tissue will heal naturally or necessitate surgical intervention, a process that is currently done by clinicians relying on visual observation and resulting in clinical judgement between only 50 per cent to 75 per cent accuracy.

“The current practice of prolonged and expensive observation with open wounds that risk infection before deciding on the best management of care is outdated,” said Professor Paul Chadwick, Spectral AI’s Executive Vice President of the Company’s UK subsidiary. “This protracted decision process burdens the patient as well as the healthcare system with unnecessary hospitalisation time. The authorisation of the DeepView System could effectively obviate the need for these long observation periods, accelerating the way we manage burn wounds in the UK.”

UKCA marking is a certification system established by the UK government to ensure that products meet specified standards for sale in the UK (England, Wales, and Scotland).

The DeepView AI-Burn is currently indicated for individuals aged 18 and above. The Company aims to extend its technology to benefit paediatric populations and is continuing to initiate case studies and case series with surgeons at leading burn centres.


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