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Medical technology & services

Spectral MD makes significant headway in a busy three months

Spectral MD Holdings Ltd (AIM:SMD), the developer of an artificial intelligence (AI) driven device designed to evaluate burns and deep-seated foot ulcers, made a strong start to the year, according to the company's quarterly results, published ahead of its US float.

Spectral has entered into a business combination agreement with Rosecliff Acquisition Corp I, a blank cheque shell company formed to allow it to list on Nasdaq.

The agreement values Spectral at $170 million. This transaction is expected to conclude in the third quarter.

As part of the process, Spectral put out its results for the three months ended March 31, 2023.

A recap of a busy three months revealed the Medical Technology Enterprise Consortium has awarded the company a $4.0 million grant. The funding is intended to fast-track the development of DeepView SnapShot M, a fully handheld variant of the company's existing DeepView device.

Additionally, Spectral MD has successfully completed the enrollment phase for its US Burn AI Training Study.

Conducted across 12 prominent US burn centres, the study involves both adult and paediatric subjects. The collected data will be used to finalise the DeepView AI-Burn algorithm and to determine the sample size for the upcoming US Burn AI Validation Study.

The company's Diabetic Foot Ulcer (DFU) clinical study in the US is also progressing smoothly, with the inclusion of additional sites in the first quarter.

The ongoing study is expected to provide the necessary data to support submissions to the US Food and Drug Administration (FDA) in the US and the UK Conformity Assessed (UKCA) in the UK.

The interim results for the DFU indication have been positive, demonstrating an improvement in AI diagnostic accuracy from 81% to 86%.

Furthermore, Spectral MD has initiated an EU clinical study for the DFU Indication in collaboration with the Royal College of Surgeons in Ireland, carried out at Connolly Hospital in Dublin, Ireland.

Turning to the financials, Spectral generated R&D revenues of $5.1mln and an operating loss of $3.6mln.

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