Machine learning predictions based on historical earnings data and price patterns
1-Day Prediction
-7.42%
$0.43
0% positive prob.
5-Day Prediction
-12.02%
$0.41
0% positive prob.
20-Day Prediction
+24.19%
$0.58
0% positive prob.
SEC 8-K filings with transcript text
Aug 12, 2026 · 100% conf.
1D
-7.42%
$0.43
Act: +7.66%
5D
-12.02%
$0.41
20D
+24.19%
$0.58
Transcript text not available. View on SEC.gov →
Mar 25, 2026
Aug 13, 2025
May 14, 2025
Apr 2, 2025
2 ea023647501ex99-1_spectral.htm
Exhibit 99.1
Spectral AI Announces 2024 Fourth Quarter and Full Year Financial Results 2024
Research & Development Revenue of $30 Million
Successful Results from the US Burn Validation Study
On Track for Regulatory Submission in US for DeepViewÔ System
DALLAS, TX – March 27, 2025 - Spectral AI, Inc. (Nasdaq: MDAI) (“Spectral AI” or the “Company”), an artificial intelligence (“AI”) company focused on medical diagnostics for faster and more accurate treatment decisions in wound care, today announced financial results for the fourth quarter (“Q4 2024”) and full year (“FY 2024”) ended December 31, 2024, and provided an update on its ongoing business activities.
“Spectral AI achieved much in 2024. Our top-line revenue reflects extensive work on our BARDA PBS contract, and our progress along multiple fronts has continued into 2025,” said Dr. J. Michael DiMaio, M.D., the Company’s Chairman of the Board. “The team’s achievements to date, and those on the horizon, are the result of a 10-year record of success in delivering on a promise to the US government and the American people to develop and commercialize our proprietary AI-Driven DeepViewÔ System wound healing assessment platform, a technology that we believe can help change the standard of care while delivering value across the healthcare ecosystem. We expect to realize our first commercial product revenue in the second half of this year. Given the pace of our product development and clinical activities in the US and internationally, we believe that we are on the proper path to generate commercial revenue across four separate DeepView System platforms covering burn and other indications within the next three years.
“We have a well-defined business focus for 2025 based on the evolution of our DeepView System from clinical stage to commercialization. We will continue to advance our research and development work under our current US government contracts for our DeepView System burn indication and plan to submit regulatory filings for the approval of this indication in the US in the first half of this year. Our recent financing agreements and the multi-year, non-dilutive funding provided by our US government contracts provide us with a sound financial foundation to pursue these objectives.”
Government Funding
●The Company continues to build on its BARDA PBS contract awarded in September 2023. This is the largest contract in our history and is valued at up to $150.0 million. This multi-year, non-dilutive contract includes an initial award of approximately $54.9 million to fund development activities through Q1 2026 to submit a De Novo FDA application for our DeepView System for burns, and for government procurement of the device for distribution to various burn centers and emergency rooms across the United States.
Burn Validation Study
● In March 2025, the Company announced the successful results of its Burn Validation Study. At both a pixel-level and an image-level, the Company’s DeepView System performed very well in assessing sensitivity, specificity and Dice score. The Company plans to submit these results to the FDA as part of its regulatory submission by the end of the second quarter of 2025 and hopes to have the FDA grant the De Novo Classification Request of the DeepView System in early 2026. As noted in our March 17, 2025 press release, with respect to scoring, the DeepView System demonstrated a statistically significant improvement for sensitivity in identifying non-healing tissue compared to burn physicians; at the image-wise level, the DeepView System scored 86.6%, while the clinical judgment annotation (“CJA”) of burn physicians scored 40.8%. At the pixel-wise level, the DeepView System scored 81.9% and the CJA of burn physicians scored 38.8%. The DeepView System also achieved statistically significant higher Dice Scores when compared to those derived from burn physicians’ CJA, representing the improved pixel-wise evaluation between predicated and true segmented wound areas with the DeepView System performing at 68.5% and burn physician’s CJA at 39.2%. The DeepView System significantly outperformed the anticipated results for image-wise specificity in segmenting non-healing wound areas with a result of 61.2% (versus management’s anticipated result of 36.0%) with the CJA of 79.1% reflecting burn physician’s conservative assessment of burn areas. The clinicians performing CJA tend to be very conservative by being more likely to diagnose wounds as healing, introducing a bias toward higher specificity. Our results exceeded our expectations and met the FDA requirement for non-inferiority of specificity when compared to CJA assessments.
Clinical Trials
●In September 2024, the Company completed its enrollment in the Burn Validation Study, which was one of the largest burn studies conducted in the US. This stud
Mar 29, 2024
2 ea020283501ex99-1_spectral.htm
Exhibit 99.1
Spectral AI Announces 2023 Fourth Quarter and Full Year Financial Results
2023 Research & Development Revenue of $18.1 Million Expected to Increase to $28.0 Million in 2024
Commercialization Underway with Revenue Expected in 2H 2024 for DeepView AI®-Burn Indication in the UK
On Track for Additional Regulatory Submissions in US and UK for DeepViewÔ System Burn and Diabetic Foot Ulcer Indications
DALLAS, TX – March 27, 2024 - Spectral AI, Inc. (Nasdaq: MDAI) (“Spectral AI” or the “Company”), an artificial intelligence (AI) company focused on medical diagnostics for faster and more accurate treatment decisions in wound care, today announced financial results for the fourth quarter (“Q4 2023”) and full year (“FY 2023”) ended December 31, 2023 and provided an update on its ongoing business activities.
“Spectral AI achieved much in 2023, and our progress along multiple fronts has continued into 2024,” said Peter M. Carlson, Chief Executive Officer. “The team’s achievements to date, and those on the horizon, are the result of a 10-year record of success in delivering on a promise to develop and commercialize our proprietary AI-Driven DeepViewÔ System wound healing assessment platform, a technology that we believe can help change the standard of care while delivering value across the healthcare ecosystem. We expect to realize our first commercial product revenue in the second half of this year. Given the pace of our product development and clinical activities in the US and internationally, we believe that we are on the proper path to generate commercial revenue across four separate DeepViewÔ System platforms covering burn and diabetic foot ulcer (DFU) within the next three years.
“We have a well-defined business focus for 2024 based on the evolution of our DeepViewÔ System from clinical stage to commercialization. We will continue to advance our research and development work under current US Government contracts for our DeepViewÔ System burn indication and plan to submit regulatory filings for the approval of this indication in the US in the first half of 2025. We are pursuing the commercialization of our DeepViewÔ System for the assessment of DFU in the US and the UK, and expect to submit regulatory filings for the approval of this indication in the US and UK in 2024. Our recent financing agreements in combination with the multi-year, non-dilutive funding provided by our US Government contracts provides us with a sound financial foundation to pursue these objectives.”
Government Funding
●In September 2023, we were awarded the largest contract in our history from the US Government valued at up to $150.0 million. This multi-year, non-dilutive contract includes an initial award of approximately $54.9 million to fund development activities through Q1 2026 for our DeepViewÔ System for burn to submit a De Novo FDA application, and for government procurement of the device for distribution at various burn centers and emergency rooms across the United States.
First Commercial Product Revenue
●In February 2024, we received UKCA Authorization to commence sales of our DeepViewÔ System for burn in the UK. We deployed our first burn device in March 2024 and expect to commence generating commercial revenues in the second half of 2024.
Regulatory
●In October 2023, our DeepView SnapShot® wound imaging system received regulatory authorization in the UK and Class 1 medical device classification with the U.S. Food and Drug Administration (FDA).
Clinical Trials
●In January 2023, we provided interim results for our DFU Clinical Study, which will be used in upcoming regulatory submissions in the UK and US.
●In December 2023, we initiated a pivotal study to validate our DeepViewÔ System for burn, which is expected to be the final clinical trial before seeking FDA approval. This study is being conducted in burn centers and emergency departments with an enrollment target of 240 subjects in both adult and pediatric patients.
Product Development
●In March 2024, we received a new contract valued at $500,000 from the US Government that provides additional support for the development of the handheld version of our DeepViewÔ System called DeepView SnapShot® M. This new award brings total support for the DeepView SnapShot® M to more than $6 million.
●In August 2023, we received ISO 13485 certification for the manufacture and distribution of our DeepViewÔ System.
Corporate
●Successfully listed on Nasdaq in September 2023, elevating our profile among US investors and other stakeholders.
●Added significant strength and industry depth to our board of directors with the appointments of Deepak Sadagopan, MHCDS, Erich Spangenberg, Dr. J. Michael DiMaio, and to our management team with the additions of Peter M. Carlson and Prof. Paul Chadwick.
●Enhanced our access to capital by comple
Nov 14, 2023
2 ea188358ex99-1_spectral.htm
Exhibit 99.1
Spectral AI Announces 2023 Third Quarter Financial Results
Highlights Continuing Progress in Developing and Commercializing AI-Driven DeepView® System Wound Healing Assessment Technology
Affirms Full Year Revenue Guidance for 2023 and 2024
November 13, 2023 - Spectral AI, Inc. (Nasdaq: MDAI) (“Spectral AI” or the “Company”), an artificial intelligence (AI) company focused on medical diagnostics for faster and more accurate treatment decisions in wound care, today announced financial results for the third quarter ended September 30, 2023 (“Q3 2023”).
“This has been an extraordinary period for Spectral AI, highlighted by our September listing on Nasdaq, continued progress towards developing and commercializing our AI-Driven DeepView® System wound healing assessment platform for burn and diabetic foot ulcers (“DFU”), and the recent receipt of the largest contract in our history a $149 million award from the United States government to advance our DeepView® System for burn wound assessment,” said Wensheng Fan, CEO of Spectral AI.
“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. 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. In the case of burn, where our DeepView® System’s current accuracy is 92% for adults and 88% for pediatrics, a non-healing assessment may suggest a surgical referral as well as determining which specific areas require excision and grafting. For DFU, where our DeepView® System’s accuracy is 86%, a non-healing assessment may justify the immediate use of advanced wound care therapy as opposed to the current ‘wait-and-see’ approach. In each case, our DeepView® System is designed to support clinicians in placing their patients on an informed, defined, and immediate path to healing, while improving outcomes, reducing hospital stays, and eliminating unnecessary expenses.”
Mr. Fan concluded, “We are preparing across all fronts for the commercial launch of our DeepView® System as early as 2024 following the receipt of necessary regulatory approvals. 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. As previously announced, we also expect 2024 revenue growth of approximately 60% from anticipated 2023 levels.”
Q3
All comparisons are to the third quarter ended September 30, 2022 (“Q3 2022”) unless otherwise stated.
●Research & Development Revenue1 was $3.4 million compared to $7.0 million, primarily due to decreased research and development work performed pursuant to the BARDA Burn II contract as clinical trials under this contract were nearing completion. New patient enrollments in our BARDA clinical study declined as the Company is completing enrollment and transitioning to the closeout phase of the study.
●Cost of revenue declined by $1.8 million, or 48.4%, primarily due to decreased activity to fulfill the BARDA Burn II contract consistent with decreased Research & Development revenue.
●Gross margin declined to 42.8% from 45.9%, primarily due to the commencement of Phase II of the Medical Technology Enterprise Consortium (“MTEC”) contract, which has a lower gross margin than the BARDA Burn II contract.
●General & administrative expenses were $5.6 million compared to $3.5 million, the result of increased headcount required to support our organizational growth, and R&D initiatives associated largely with ongoing studies in support of planned regulatory applications for our DFU indication.
●Non-recurring transaction costs associated with the September 2023 consummation of the Company’s business combination that resulted in our Nasdaq listing were $7.6 million as compared to no such costs.
●Net loss was $(10.6) million, or $(0.77) per share, compared to a net loss of $(0.4) million, or $(0.03) per share. Net loss for Q3 2023 included the above-referenced $7.6 million in non-recurring transaction costs.
●Adjusted EBITDA loss was $(3.9) million compared to Adjusted EBITDA of $0.0 million.
●As of September 30, 2023, cash and cash equivalents totaled $7.3 million and the Company had no long-term debt.
2023 and 2024 Guidance
The Company is reiterating its revenue guidance of approximately $17.4 million for full year 2023 and approximately $28.0 million for full year 2024. Financial guidance for FY2024 does not reflect the material financial contributions the Company expects would result from the commercialization of our DeepView® System for DF
This page provides Spectral AI Inc. (MDAIW) earnings call transcripts from SEC 8-K filings along with AI-powered predictions for post-earnings price movements. Our machine learning models analyze historical earnings data, pre-earnings price patterns, volume changes, and volatility to predict 1-day, 5-day, and 20-day returns after each earnings release.
Earnings transcripts are sourced directly from SEC EDGAR filings. Predictions are generated using gradient boosting models trained on MDAIW's historical earnings reactions. All predicted returns are shown as percentages, and predicted prices are calculated from the closing price at the time of prediction. Past performance does not guarantee future results.