Spectral AI Inc (NASDAQ:MDAI) told investors it had an “extraordinary” third quarter, highlighted by its listing on Nasdaq and the continued progress made with its DeepView System Wound Healing Assessment Technology.
Releasing results for the quarter, Spectral AI CEO Wensheng Fan noted the company also received the largest contract in its history: a $149 million award from the US government to advance the AI-driven DeepView System for burn wound assessment.
“We believe that our DeepView System is the only digital predictive medical diagnostic product that provides clinicians with an objective and immediate assessment of a wound’s healing potential through the application of AI,” Fan commented in a statement.
“Multiple clinical studies have validated the efficacy of our DeepView System in assessing – within seconds – whether a wound will heal on its own or will require medical intervention to do so.”
Fan said Spectral AI is preparing for the commercial launch of the wound healing assessment platform for burn and diabetic foot ulcers (DFU) as early as 2024 following the receipt of necessary regulatory approval.
“To that end, we remain on track to submit applications for FDA, UKCA, and CE mark approval for the DeepView System DFU indication and 3D wound measurement in 2024 and for FDA and CE mark approval for the burn indication in 2025,” he added.
“As previously announced, we also expect 2024 revenue growth of approximately 60% from anticipated 2023 levels.”
For the three months ended September 30, 2023, the company reported research and development revenue of $3.4 million, down from $7 million, primarily due to decreased research and development work performed under its BARDA Burn II contract as clinical trials under the contract neared completion. In line with that, its cost of revenue declined by $1.8 million, or 48%.
It reported a net loss of $10.6 million for the year, including non-recurring transaction costs related to the business combination agreement with Rosecliff Acquisition Corp I, a blank cheque shell company formed to allow it to list on Nasdaq.
It ended September with cash and cash equivalents of $7.3 million and no long-term debt.
The company has guided for full-year 2023 revenue of roughly $17.4 million, rising to $28 million in 2024.
It added that the 2024 guidance does not reflect the material financial contribution it expects to result from the commercialization of the DeepView system for DFU and 3D wound measurement following the receipt of the necessary regulatory clearances.
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