Financial Data and Key Metrics Changes - Research and development revenue for Q4 2024 was $7.6 million, up from $5.3 million in the prior year, reflecting increased work under the BARDA PBS contract [19] - Full year 2024 R&D revenue reached $29.6 million, a 63.5% increase from $18.1 million in 2023, marking the highest revenue in the company's history [21] - Gross margin for Q4 2024 declined to 44% from 46.1% in the prior year, primarily due to a smaller percentage of direct labor on the BARDA PBS contract [20] - General and administrative expenses decreased to $4.6 million in Q4 2024 from $5.4 million in the prior year [21] - Cash and cash equivalents as of December 31, 2024, totaled $5.2 million, with a current cash position exceeding $14 million following long-term debt financing [22][24] Business Line Data and Key Metrics Changes - The DeepView system demonstrated exceptional performance in a burn validation study, achieving 86.6% sensitivity compared to 40.8% from clinicians [10] - The DICE score for the AI algorithm reached 68.5%, significantly outperforming the 39.2% from burn physicians [10] - The company plans to submit results to the FDA by the end of Q2 2025, seeking de novo classification in 2026 [11] Market Data and Key Metrics Changes - The company has successfully deployed three DFU systems in Australia at leading hospitals, enhancing its presence in the UK and Australia [14] - The response to the DeepView system in the UK and Australia has been exceptional, with strong enthusiasm from medical specialists [13] Company Strategy and Development Direction - The company is focused on advancing its DeepView technology for wound and burn assessment, with a commitment to commercialization following FDA clearance [6][11] - A dedicated intellectual property subsidiary, Spectral IP, was formed to monetize IP assets, with plans to spin off into an independent publicly traded company [17][18] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the company's growth prospects and the successful execution of its strategic objectives [26] - The company anticipates a revenue forecast of approximately $21.5 million for fiscal year 2025, reflecting a step back in revenue as it prepares for FDA submission [25][43] Other Important Information - The company has reduced monthly operating losses from $4.6 million in the first half of 2024 to approximately $2 million in the second half [23] - The company has satisfied approximately $10.1 million of its short-term debt, enhancing its financial foundation [24] Q&A Session Summary Question: Plans for commercialization and staffing - The company plans to precondition the market with studies and mobilize a sales force as it anticipates FDA clearance [30] Question: Revenue guidance for 2025 - The company expects a slight revenue decrease in 2025 as it positions for FDA submission, with a ramp-up anticipated in 2026 [42][43] Question: Details on the FDA submission process - The submission will include a comprehensive package reviewed by BARDA before submission to the FDA [45][46] Question: DICE score significance and FDA perspective - The DICE score is crucial for evaluating segmentation tasks and provides a balanced view of the model's performance [50][51] Question: Future deployments in Australia and the UK - The company does not plan to expand the number of units but will focus on deeper utilization and feedback from existing sites [53] Question: Timeline for pediatric study data - The pediatric study data is merged with adult data, and preliminary processing has been completed [58][63] Question: Development milestones for DPU Snapshot M - The company is gathering feedback from military users and plans to submit further applications in 2026 [64] Question: Learnings from the UK deployment - Positive feedback has been received, and the company anticipates sharing data at upcoming scientific meetings [70]

Financial Data and Key Metrics Changes - Research and development revenue for Q4 2024 was $7.6 million, up from $5.3 million in the prior year, reflecting increased work under the BARDA PBS contract [20] - Full year 2024 R&D revenue reached $29.6 million, a 63.5% increase from $18.1 million in 2023, marking the highest revenue in the company's history [22] - Gross margin for Q4 2024 declined to 44% from 46.1% in the prior year, primarily due to a smaller percentage of direct labor on the BARDA PBS contract [21] - Full year gross margin rose to 44.9% from 43.6% in the prior year, driven by a higher reimbursement rate under the current BARDA PBS contract [22] - General and administrative expenses decreased to $4.6 million in Q4 2024 from $5.4 million in the prior year [21] Business Line Data and Key Metrics Changes - The DeepView system demonstrated exceptional performance in predicting burn healing potential, significantly outperforming clinical judgment in sensitivity, DICE score, and specificity [10][11] - The company plans to submit results to the FDA by the end of Q2 2025, seeking de novo classification in 2026 [12] Market Data and Key Metrics Changes - The response to the DeepView system in the UK and Australia has been exceptional, with strong enthusiasm from medical specialists [14] - Three DeepView systems have been successfully deployed in leading hospitals in Australia, enhancing the company's presence in the region [15] Company Strategy and Development Direction - The company is focused on advancing its DeepView technology for wound and burn assessment, with key milestones in regulatory pathways and clinical validation [8] - Plans include gathering real-world clinical feedback across multiple continents to support FDA submissions and commercialization strategies [13] - The formation of Spectral IP aims to monetize intellectual property assets within healthcare and AI sectors, with a planned spin-off into an independent publicly traded company [18] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the company's progress and the potential for growth, emphasizing a focus on finance, focus, and finish [27] - The company anticipates a revenue forecast of approximately $21.5 million for fiscal year 2025, with expectations of a step back in revenue as it prepares for FDA submission [26][45] Other Important Information - The company has received over $7 million in government funding for the development of the Snapshot M diagnostic tool, which is expected to be ready for military deployment in 2027 [16] - Total monthly operating losses were reduced from $4.6 million in the first half of 2024 to approximately $2 million in the second half [25] Q&A Session Summary Question: Plans for commercialization and staffing - The company plans to precondition the market with studies and mobilize a sales force as they anticipate FDA clearance for commercialization [31][32] Question: Revenue guidance for 2025 - The company expects a slight decrease in revenue for 2025 as it positions for FDA submission, with a ramp-up anticipated in 2026 [44][45] Question: FDA submission requirements - The submission will include a comprehensive package with multiple sections, all reviewed by BARDA before submission to the FDA [46][47] Question: DICE score significance - The DICE score is crucial for evaluating segmentation tasks and is important for FDA assessments, balancing precision and recall [51][52] Question: Future deployments in Australia and the UK - The company does not plan to expand the number of units but will focus on deeper utilization and feedback from existing sites [53][54] Question: Pediatric study timeline - Data from the pediatric study is merged with adult data, and the company feels confident in the representative sample for FDA submission [62] Question: Development milestones for Snapshot M - The company is incorporating preliminary feedback from military assessments and plans to submit further applications in 2026 [63][64] Question: Learnings from UK deployments - Positive feedback has been received from UK users, and the company anticipates sharing data at upcoming scientific meetings [67][68]

Core Insights - Spectral AI, Inc. reported a significant increase in Research & Development revenue for FY 2024, reaching $29.6 million, a 63.5% increase from $18.1 million in FY 2023, primarily driven by the BARDA PBS contract [11][10] - The company is on track for regulatory submission of its DeepView™ System for burn treatment in the US, with expectations to generate commercial revenue from multiple platforms within the next three years [2][3] - The successful results from the Burn Validation Study indicate that the DeepView System significantly outperformed traditional clinical assessments in identifying non-healing tissue, with image-wise sensitivity at 86.6% compared to 40.8% for burn physicians [5][6] Financial Performance - For Q4 2024, Research & Development revenue was $7.6 million, up from $5.3 million in Q4 2023, reflecting increased work on the BARDA PBS contract [10][11] - Gross margin for Q4 2024 was 44.0%, a slight decrease from 46.1% in the prior year, attributed to a smaller percentage of direct labor on the BARDA PBS contract [12] - The net loss for FY 2024 was $(15.3) million, or $(0.85) per share, an improvement from a net loss of $(20.9) million, or $(1.48) per share, in FY 2023 [16][17] Business Highlights - The BARDA PBS contract, valued at up to $150 million, is the largest in the company's history and includes an initial award of approximately $54.9 million for development activities [4] - The company plans to submit regulatory filings for the DeepView System's burn indication in the first half of 2025, aiming for FDA approval by early 2026 [3][5] - Recent financing agreements have strengthened the company's financial foundation, with an equity financing and long-term debt transaction raising $11.2 million [13][22] Product Development and Clinical Trials - The Burn Validation Study, one of the largest burn studies in the US, involved 160 patients and demonstrated the DeepView System's superior performance in assessing wound healing [13][5] - The company is advancing the development of a handheld version of the DeepView System, called DeepView SnapShot M, supported by a $500,000 contract from the Defense Health Agency [13] Future Outlook - The company forecasts revenue of approximately $21.5 million for FY 2025, not including potential contributions from the sale of the DeepView System in international markets [19] - The ongoing development and commercialization of the DeepView System are expected to change the standard of care in wound management, providing faster and more accurate treatment insights [2][21]

Core Viewpoint - Spectral AI, Inc. has successfully completed a debt financing agreement of up to $15 million, which will support the commercialization of its AI-driven DeepView® System for predicting burn healing potential [1][2][3] Financing Details - The financing agreement has a term of three years, with an initial drawdown of $8.5 million and a potential additional $6.5 million contingent upon FDA clearance of the DeepView System [1][2] - The financing includes an interest-only payment period of at least 15 months, extendable to 24 months upon meeting specific milestones [2] - The agreement also features warrant coverage of 8.5% of the total funding commitment, with an exercise price of $1.80 per share [2] Company Strategy and Goals - The funds will enable Spectral AI to accelerate its product commercialization efforts, particularly the upcoming U.S. launch of the DeepView System [1][3] - The company aims to transform healthcare providers' ability to predict burn wound healing potential, ultimately improving patient outcomes [3][4] Product Overview - The DeepView System utilizes multi-spectral imaging and AI algorithms to provide an objective assessment of a burn wound's healing potential prior to treatment [4] - The technology is designed to exceed current standards of care, offering faster and more accurate treatment insights, thereby reducing healthcare costs [4]

Company Overview - Spectral AI is a Dallas-based predictive AI company focused on medical diagnostics, particularly in wound care, with initial applications for burn patients [7] - The company has developed the AI-driven DeepView® System, which utilizes multi-spectral imaging and AI algorithms to predict burn healing potential [1] Planned Spinoff - Spectral AI's subsidiary, Spectral IP, Inc., has filed a registration statement with the SEC for a planned spinoff through an initial public offering (IPO) [1] - The subsidiary will be renamed SIM IP Inc. prior to the completion of the offering [1] - The number of shares and price range for the proposed offering have not yet been determined [2] Listing and Underwriters - SIM IP has applied to list its common stock on the Nasdaq Capital Market under the ticker symbol "SMIP" [2] - Dominari Securities LLC is acting as the representative of the underwriters, with Revere Securities LLC as the co-underwriter for the offering [3] Registration Statement Details - A registration statement on Form S-1 was filed with the SEC on March 20, 2025, but has not yet become effective [5] - The proposed offering will be made only by means of a prospectus forming part of the registration statement [4] Future Outlook - The company aims to revolutionize wound care management by providing faster and more accurate treatment insights, ultimately improving patient outcomes and reducing healthcare costs [7]

Core Viewpoint - Spectral AI announced successful results from its Burn Validation Study for the DeepView® System, which uses AI and multi-spectral imaging to predict burn healing potential, aiming to transform burn care and expedite patient treatment [1][4]. Group 1: Study Overview - The Burn Validation Study, one of the largest burn trials in the U.S., enrolled 164 patients (115 adults and 49 pediatric) to assess the DeepView System's predictive capabilities [2]. - The study aimed to demonstrate the DeepView technology's ability to predict burn wound healing potential on the first day of injury, outperforming current methods [2]. Group 2: Performance Metrics - The DeepView System showed significant improvements in sensitivity, scoring 86.6% at the image-wise level compared to 40.8% for burn physicians, and 81.9% at the pixel-wise level versus 38.8% for physicians [5]. - The Dice Score for the DeepView System was 68.5%, significantly higher than the 39.2% achieved by burn physicians, indicating better pixel-wise evaluation of wound areas [5]. - In terms of specificity, the DeepView System achieved 61.2%, exceeding the anticipated 36.0%, while burn physicians scored 79.1% [5]. Group 3: Future Plans - Spectral AI plans to submit the study results to the FDA by mid-2025, seeking De Novo Classification for the DeepView System, with hopes for commercialization in early 2026 [3][4]. - The company is prepared to commercialize the DeepView System in the U.S. upon FDA approval, aiming to enhance patient care and reduce healthcare costs [3][7].

Core Insights - Spectral AI has completed the installation of three DeepView System devices in Australia, in partnership with PolyNovo Limited, to enhance burn wound care [1][4] - The DeepView System utilizes multi-spectral imaging and AI algorithms to provide an objective assessment of burn wounds' healing potential, trained on over 340 billion clinically validated data points [2][5] - The deployment of these devices is part of a strategy to support commercial roll-out based on clinician evaluations and experiences [1][4] Company Overview - Spectral AI is a Dallas-based predictive AI company focused on medical diagnostics, particularly in wound care for burns and diabetic foot ulcers [5] - The DeepView System aims to revolutionize wound management by providing faster and more accurate treatment insights, ultimately improving patient outcomes and reducing healthcare costs [5] Clinical Impact - Clinicians, such as Professor Peter Maitz, express optimism about the DeepView System's potential to enhance patient care and improve treatment outcomes for burn patients [3] - The Chairman of the Board at Spectral AI, Dr. J. Michael DiMaio, emphasizes the transformative impact of the DeepView System in burn wound care, highlighting its data-driven assessment capabilities [4]

Core Viewpoint - Spectral AI, Inc. will report its financial results for the fourth quarter and full year ended December 31, 2024, on March 27, 2025, after market close, and will host a conference call to discuss these results [1]. Company Overview - Spectral AI, Inc. is a Dallas-based predictive AI company focused on medical diagnostics, particularly in wound care, with initial applications for burn patients [3]. - The company has developed the AI-driven DeepView® System, which utilizes multi-spectral imaging and AI algorithms to predict burn healing potential and has received Breakthrough Device Designation from the FDA in 2018 [1][3]. - DeepView aims to provide clinicians with an objective and immediate assessment of a wound's healing potential, thereby improving patient outcomes and reducing healthcare costs [3]. Financial Reporting - The financial results for the fourth quarter and full year will be reported on March 27, 2025, with a corresponding conference call scheduled for 5:00 pm Eastern Time [1][2].

Core Insights - Spectral AI is set to report its financial results for Q4 and the full year ended December 31, 2024, on March 27, 2025, after market close [1] - The company will host a conference call at 5:00 pm Eastern Time to discuss these results [1] Company Overview - Spectral AI, based in Dallas, focuses on predictive AI for medical diagnostics, particularly in wound care, with initial applications for burn patients [2] - The company's DeepView System utilizes multi-spectral imaging and AI algorithms to assess burn healing potential, aiming to improve treatment decisions and patient outcomes [2] - DeepView is designed to provide objective and immediate assessments of wound healing potential, with the goal of exceeding current standards of care and reducing healthcare costs [2]

Core Insights - Spectral AI has satisfied its final obligations under its debt facility with Yorkville Advisors and retains access to an additional financing of up to $17.5 million under an existing standby equity purchase agreement [1] Company Overview - Spectral AI, based in Dallas, focuses on predictive AI for medical diagnostics, particularly in wound care, with initial applications for burn patients and diabetic foot ulcers [3] - The company's DeepView System utilizes multi-spectral imaging and AI algorithms to predict burn healing potential, aiming to provide faster and more accurate treatment insights, thereby improving patient outcomes and reducing healthcare costs [3] Future Developments - The company is advancing towards its FDA submission to bring its technology to burn care institutions across the U.S. [2]