Spectral AI nears first sales of wound care system

Spectral AI is on the brink of becoming a commercial-stage company, with the first sales of its DeepView wound imaging system due to start in its first market, the UK, later this year.

DeepView has been developed to take some of the guesswork out of handling serious second- and third-degree burns – to help physicians decide whether surgery is needed, for example – which at present often involves waiting to see if tissue regeneration starts to take place.

The diagnostic platform combines artificial intelligence-powered predictive analytics with medical imaging to give clinicians an assessment of a burn patient on day one that – according to the company – is 92% accurate at predicting successful regeneration.

It has been trained on thousands of burn biopsy samples and performs very well against historical estimates of the accuracy of assessment of burns by clinicians which, according to one study, is around 60% to 75%, even when carried out by an experienced burn surgeon.

In its first-quarter results update reported this week, Spectral AI’s chief executive, Peter Carlson, said the company has made “important strides” towards its first commercial revenues with the first deployment of DeepView systems in the UK.

Sales were authorised under the UK Conformity Assessed (UKCA) mark – introduced after Brexit to run alongside the EU’s CE Mark system – earlier this year, and the first devices have been deployed at multiple facilities in the UK for evaluation purposes, he added. More deployments are planned throughout the summer.

In preparation for the rollout, the Dallas, US-based company recently hired medical device industry veteran Jeremiah Sparks as its head of commercialisation, who joined from AVITA Medical and previously held positions at Johnson & Johnson, Healthpoint, and Allergan.

Meanwhile, Spectral AI is also progressing a 240-subject clinical trial of DeepView in the US in paediatric and adult patients with burns, with a view to filing for FDA approval next year, and additional studies in diabetic foot ulcers (DFU).

“We are on track to file additional US and UK regulatory submissions in 2024 and 2025 for the approval of our DeepView system, and expect to expand our commercial revenue platforms over the next two years,” said Carlson.

Revenues for the first quarter were $6.3 million, coming mainly from contracts with the US Biomedical Advanced Research & Development Authority (BARDA), and the company is expecting to bring in around $28 million for the full year.