Spectral AI Inc (NASDAQ:MDAI) hailed progress in the first quarter towards first commercial product revenue later this year, along with strengthening of the management team and financial position.
The developer of the DeepView wound imaging system reported research & development revenue of $6.3 million for Q1, compared to $5.1 million a year ago, as it carried out an increased level of activity under the contracts with the US Biomedical Advanced Research & Development Authority (BARDA).
Revenue guidance of approximately $28 million for the full year was reiterated.
At the end of March, cash stood at $10.2 million, up from $4.8 million at the end of December, which Spectral said reflected its improved capital structure.
CEO Peter Carlson highlighted the company's commercial progress in the UK and clinical trials in the US.
“We made important strides towards generating our first commercial product revenue later this year with the deployment of our DeepView System for burn in the UK,” he said.
Following the regulatory authorization, devices have been deployed at several UK facilities for evaluation, with more planned through the summer, the company said.
As for US approval, the company started to enrol the first of 240 planned patients at multiple burn centers and emergency departments in what is anticipated to be its final clinical trial before seeking Food & Drug Administration approval in 2025.
The clinical study is designed to further demonstrate the efficacy of the DeepView System in providing a “day one” healing assessment of burn wounds and diabetic foot ulcers.
“We remain driven by our steadfast belief that our proprietary, AI-Driven, DeepView System can help change the standard of care in wound assessment by providing predictive clinical insights that result in more effective and more efficient care across the healthcare ecosystem.
“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,” Carlson said.
The quarter saw $2.7 million raised from a common stock purchase agreement with an investment bank, with another $3 million available, and $4.6 million received from a fixed price standby equity purchase agreement with an investor, where a further $5 million is anticipated following this month’s annual meeting and the remaining $2.5 million of advances within two more months.
General and administrative expenses were steady at $5.1 million and the net loss of $3.2 million was an improvement from the $3.6 million last year.