Release Date: March 27, 2025
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Q: What are Spectral AI's plans for commercialization and staffing as they approach the launch of their product? A: Dr. J. Michael Dimaio, Non-Executive Director, explained that they are preparing for FDA clearance and will precondition the market through studies, presentations, and publications. They are mobilizing a sales force and gathering real-world evidence from the UK and Australia to support commercialization. However, specific details on staffing and co-promotion partners are still under discussion.
Q: How does Spectral AI plan to manage sales and medical liaisons if they pursue a go-alone strategy? A: Dr. J. Michael Dimaio stated that they already have service personnel for research purposes and are planning to roll out approximately 170 more units under a federal government contract. A small sales force will be necessary for the initial rollout, but the exact number of sales reps and medical specialists needed is not yet determined.
Q: Can you explain the expected revenue for 2025 and the potential for commercial revenue? A: Vincent Capone, CFO, noted that 2025 is expected to see a step back in revenue as they prepare for FDA submission and clearance. The forecasted revenue of $21.5 million does not include potential commercial revenue from the UK or Australia, as these are not expected to significantly impact overall revenue.
Q: What are the remaining steps for FDA submission following the positive results of the validation study? A: Dr. J. Michael Dimaio outlined that they need to complete the statistical plan, hardware and software validation, and other sections required for the FDA application. The submission will be reviewed by BARDA before going to the FDA.
Q: Can you provide more context on the dice score and its importance in the FDA's evaluation? A: Dr. Jihong Wang, Director of Data Science, explained that the dice score measures the overlap between AI model segmentation and ground truth, providing a balanced view of the model's performance. The FDA requires both detection and segmentation performance metrics to understand the device's capabilities.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
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