DALLAS, Sept. 19, 2025 (GLOBE NEWSWIRE) -- 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 it has been named to TIME’s World’s Top HealthTech Companies 2025 list. The ranking, released September 18, 2025, can be viewed on Time.com. The list, compiled by TIME and Statista Inc., recognizes leading innovators advancing healthcare globally thro ...

DALLAS, Sept. 10, 2025 (GLOBE NEWSWIRE) -- 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 its prominent role at the European Burns Association (EBA) conference, held from September 3rd – 6th in Berlin, Germany. The Company was featured in multiple presentations, highlighting its contributions to advancing burn care across the globe. Key Pr ...

Executive Summary & Business Highlights [Q2 Overview](index=1&type=section&id=Q2%20Overview) Spectral AI reported Q2 2025 results and submitted its DeepView system's De Novo application to the FDA, a key step for US market entry - Spectral AI reported **Q2 2025 financial results** and completed the early submission of its **DeepView system's De Novo application** to the FDA[2](index=2&type=chunk)[3](index=3&type=chunk) - The FDA submission is a **critical milestone** for the **DeepView system's entry into the US market**, aiming to provide clinicians with **immediate, data-driven assessment tools** to aid clinical decisions and potentially **improve patient outcomes**[3](index=3&type=chunk) [SELECT BUSINESS HIGHLIGHTS](index=1&type=section&id=SELECT%20BUSINESS%20HIGHLIGHTS) The company completed the DeepView system's De Novo application submission to the FDA in June 2025, a crucial step for global market approval - The company completed the **DeepView system's De Novo application submission** to the FDA in **June 2025**, a critical step for obtaining FDA approval and launching it into the global medical market[4](index=4&type=chunk) Q2 2025 Financial Results Overview [Research & Development Revenue](index=1&type=section&id=Research%20%26%20Development%20Revenue) Q2 2025 R&D revenue decreased by 32.0% to $5.1 million, driven by the completion of BARDA contract clinical trials Research & Development Revenue | Metric | Q2 2025 (million USD) | Q2 2024 (million USD) | Change (%) | | :--- | :--- | :--- | :--- | | R&D Revenue | 5.1 | 7.5 | -32.0% | - The decrease in R&D revenue is primarily due to the completion of clinical trials and other reimbursable research costs under the BARDA PBS contract in **2024**[6](index=6&type=chunk) [Gross Margin](index=1&type=section&id=Gross%20Margin) Q2 2025 gross margin was 45.2%, slightly lower than 46.6% in Q2 2024, due to higher non-reimbursable BARDA PBS contract expenses Gross Margin | Metric | Q2 2025 | Q2 2024 | Change (percentage points) | | :--- | :--- | :--- | :--- | | Gross Margin | 45.2% | 46.6% | -1.4 | - Gross margin slightly decreased, primarily due to **increased non-reimbursable expenses** related to the BARDA PBS contract[7](index=7&type=chunk) [General & Administrative Expense](index=1&type=section&id=General%20%26%20Administrative%20Expense) Q2 2025 general and administrative expenses were $4.4 million, down from $5.8 million in the prior year, reflecting ongoing operational efficiency efforts General & Administrative Expense | Metric | Q2 2025 (million USD) | Q2 2024 (million USD) | Change (%) | | :--- | :--- | :--- | :--- | | General & Administrative Expense | 4.4 | 5.8 | -24.1% | - The decrease in general and administrative expenses is attributed to the company's **continued focus on operational efficiency**[8](index=8&type=chunk) [Other Income/(Expense)](index=1&type=section&id=Other%20Income%2F%28Expense%29) Q2 2025 other income/(expense) significantly declined to negative $5.9 million from negative $0.4 million in Q2 2024, mainly due to a $5.4 million increase in warrant liability fair value Other Income/(Expense) | Metric | Q2 2025 (million USD) | Q2 2024 (million USD) | Change (million USD) | | :--- | :--- | :--- | :--- | | Other Income/(Expense) | (5.9) | (0.4) | -5.5 | | Change in fair value of warrant liability | (5.4) | 0.348 | -5.797 | - The significant decrease in other income/(expense) is primarily due to a **$5.4 million increase in the fair value of warrant liability**[9](index=9&type=chunk) [Net Income/(Loss)](index=1&type=section&id=Net%20Income%2F%28Loss%29) The company reported a net loss of $7.9 million in Q2 2025, compared to $2.9 million in Q2 2024, primarily impacted by warrant liability changes, while the first six months of 2025 saw a reduced net loss of $5.1 million versus $6.1 million in 2024, reflecting improved operating expense management Net Income/(Loss) | Metric | Q2 2025 (million USD) | Q2 2024 (million USD) | Change (million USD) | | :--- | :--- | :--- | :--- | | Net Loss | (7.9) | (2.9) | -5.0 | Net Income/(Loss) (Six Months) | Metric | H1 2025 (million USD) | H1 2024 (million USD) | Change (%) | | :--- | :--- | :--- | :--- | | Net Loss | (5.1) | (6.1) | -16.4% | - The **Q2 net loss increased** primarily due to changes in the **fair value of warrant liability**[10](index=10&type=chunk) - The **net loss for the first half of the year decreased by 16.4%** year-over-year, indicating progress in managing operating expenses[11](index=11&type=chunk) Financial Condition & Guidance [Financial Condition](index=3&type=section&id=Financial%20Condition) As of June 30, 2025, the company's cash position improved to $10.5 million from $5.2 million at December 31, 2024, supported by debt and equity financing Financial Condition | Metric | June 30, 2025 (million USD) | December 31, 2024 (million USD) | Change (million USD) | | :--- | :--- | :--- | :--- | | Cash | 10.5 | 5.2 | 5.3 | - The company completed a **debt financing agreement of up to $15.0 million** in Q1 2025, with an initial draw of **$8.5 million**[12](index=12&type=chunk) - Approximately **$2.7 million in equity financing** was raised from institutional and other new and existing investors[12](index=12&type=chunk) [2025 Guidance](index=3&type=section&id=2025%20Guidance) The company reaffirmed its FY 2025 revenue guidance of approximately $21.5 million, excluding DeepView™ system sales for burn indications or other significant commercialization contributions 2025 Fiscal Year Revenue Guidance | Metric | FY 2025 Revenue Guidance (million USD) | | :--- | :--- | | Revenue | ~21.5 | - The financial guidance **excludes sales contributions** from the DeepView™ system for burn indications or any additional significant financial contributions from its commercialization[13](index=13&type=chunk) Company Information & Disclosures [CONFERENCE CALL](index=3&type=section&id=CONFERENCE%20CALL) The company will host a conference call today at 5:00 PM ET to discuss these results, accessible via phone or the investor relations page of its website - The conference call is scheduled for **5:00 PM ET** today[14](index=14&type=chunk) - Investors can access the webcast via the investor relations page on the company's website: **https://investors.spectral-ai.com/news-events/events**[14](index=14&type=chunk) [About Spectral AI](index=3&type=section&id=About%20Spectral%20AI) Spectral AI, Inc. is a Dallas-based predictive AI company focused on medical diagnostics for wound care, aiming for faster, more accurate treatment decisions, initially for burn patients - Spectral AI is a **predictive AI company** focused on **medical diagnostics for wound care**, aiming for faster, more accurate treatment decisions[15](index=15&type=chunk) - The DeepView® system is designed as a predictive device to provide clinicians with **objective, immediate assessments of burn wound healing potential**, to improve patient outcomes and reduce healthcare costs[15](index=15&type=chunk) [Forward-Looking Statements](index=3&type=section&id=Forward-Looking%20Statements) This press release contains "forward-looking statements" protected by the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, which involve known and unknown risks and uncertainties - Forward-looking statements are **not guarantees of future performance** and involve known and unknown risks, uncertainties, assumptions, and other important factors that could cause actual results to differ materially from expectations[16](index=16&type=chunk) - Investors should carefully consider the factors and other risks and uncertainties described in the "Risk Factors" section of the company's filings with the SEC[17](index=17&type=chunk) [For Media and Investor Relations, please contact](index=3&type=section&id=For%20Media%20and%20Investor%20Relations%2C%20please%20contact) Media and investor relations inquiries should be directed to David Kugelman at Atlanta Capital Partners LLC, with contact details provided - Media and investor relations contact: **David Kugelman, Atlanta Capital Partners LLC**[18](index=18&type=chunk) - Contact information includes: **(866) 692-6847 (Toll-Free in US and Canada), (404) 281-8556 (Cell & WhatsApp), Email: dk@atlcp.com**[18](index=18&type=chunk) Condensed Consolidated Financial Statements [Condensed Consolidated Balance Sheet](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheet) As of June 30, 2025, cash increased to $10.524 million, total assets reached $16.009 million, while warrant liability significantly rose to $10.555 million, leading to total liabilities of $25.160 million and an expanded stockholders' deficit of $9.151 million Condensed Consolidated Balance Sheet | Metric (thousand USD) | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash | 10,524 | 5,157 | | Total Current Assets | 14,001 | 10,122 | | Total Assets | 16,009 | 12,095 | | **Liabilities & Stockholders' Deficit** | | | | Warrant Liability | 10,555 | 6,451 | | Total Current Liabilities | 16,186 | 17,644 | | Total Liabilities | 25,160 | 19,346 | | Stockholders' Deficit | (9,151) | (7,251) | [Condensed Consolidated Statements of Operations](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) In Q2 2025, R&D revenue was $5.065 million, gross profit was $2.290 million, net loss was $7.968 million, and basic and diluted loss per share was $0.31; for the first six months, R&D revenue was $11.772 million, net loss was $5.071 million, and basic and diluted loss per share was $0.21 Condensed Consolidated Statements of Operations | Metric (thousand USD) | Q2 2025 | Q2 2024 | H1 2025 | H1 2024 | | :--- | :--- | :--- | :--- | :--- | | R&D Revenue | 5,065 | 7,478 | 11,772 | 13,804 | | Gross Profit | 2,290 | 3,314 | 5,458 | 6,259 | | Operating Loss | (2,123) | (2,442) | (3,019) | (4,585) | | Change in fair value of warrant liability | (5,449) | 348 | (1,196) | 368 | | Net Loss | (7,968) | (2,864) | (5,071) | (6,069) | | Net Loss Per Share – Basic and Diluted | (0.31) | (0.16) | (0.21) | (0.36) | [Unaudited Condensed Consolidated Statements of Cash Flows](index=6&type=section&id=Unaudited%20Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) For the first six months of 2025, net cash used in operating activities improved to $4.867 million from $8.042 million in the prior year, with net cash provided by financing activities at $10.185 million, leading to an ending cash balance of $10.524 million Unaudited Condensed Consolidated Statements of Cash Flows | Metric (thousand USD) | H1 2025 | H1 2024 | | :--- | :--- | :--- | | Net Cash Used in Operating Activities | (4,867) | (8,042) | | Net Cash Provided by Financing Activities | 10,185 | 10,131 | | Net Increase in Cash | 5,367 | 2,087 | | Cash at End of Period | 10,524 | 6,877 | - **Cash outflow from operating activities significantly decreased**, reflecting improved operational efficiency[25](index=25&type=chunk) - **Cash inflow from financing activities** primarily resulted from proceeds from the issuance of common stock and warrants, as well as notes[25](index=25&type=chunk)

Financial Data and Key Metrics Changes - Research and development revenue decreased to $5,100,000 from $7,500,000 in the second quarter of the previous year, reflecting reduced reimbursements under the BARDA Project BioShield contract [12] - Gross margin slightly decreased to 45.2% from 46.6% in the same quarter last year due to lower reimbursed expenses under the BARDA contract [13] - General and administrative expenses were significantly reduced from $5,800,000 in 2024 to $4,400,000 in 2025, primarily due to a focus on operating efficiencies [13] - The company reported a net loss of $7,900,000 in 2025 compared to a net loss of $2,900,000 in 2024, attributed to an increase in the fair value of publicly traded warrant liability [13] - Cash and cash equivalents totaled $10,500,000 as of June 30, 2025, up from $5,200,000 on December 31, 2024, due to successful financing [14] Business Line Data and Key Metrics Changes - The company is focusing on the commercialization of the DeepView system, with significant progress made in FDA submission [6][9] - The FDA submission is considered a key driver in the evolution of the business, with expectations for further interaction in the coming months [10] Market Data and Key Metrics Changes - The company does not expect material contributions from sales of the DeepView system in the UK or Australia for 2025, focusing instead on usage and learning from these markets [15][31] Company Strategy and Development Direction - The company emphasizes three principles: finance, focus, and finish, with a strong start to the year and a focus on commercialization plans [6][48] - The company is developing a thorough commercialization plan involving BARDA, which will assist in rolling out initial devices upon FDA clearance [22] Management's Comments on Operating Environment and Future Outlook - Management remains optimistic about future prospects and is focused on the commercialization of the DeepView system [48] - The company is studying the UK market to gather insights that can be applied to the US market [33] Other Important Information - The healthcare intellectual property subsidiary, Spectral IP Inc., is undergoing SEC registration for its initial public offering, requiring limited management resources [11] Q&A Session Summary Question: Discussion on the submission for DeepView and commercial organization preparation - Management expects FDA clearance in the first half of next year and is developing a commercialization plan with BARDA's involvement [20][21] Question: Utility outside of burns for the DeepView system - Management indicated potential applications in wound care and other medical assessments, emphasizing the device's ability to differentiate healing and non-healing tissue [25][26] Question: Activities for deployment in the UK and Australia - Management highlighted the UK market's approval and its usefulness for burn care, focusing on learning from these markets rather than immediate sales [31][32] Question: Regulatory pathway for the handheld device - Management confirmed that the handheld device will use the cart-based device as a predicate for regulatory approval, with funding from military pathways [38] Question: Dialogue with BARDA regarding system rollout post-approval - Management refrained from speculating on BARDA's actions but noted that the contract includes methodologies for device rollout [43]

Part I. Financial Information [Item 1. Interim Financial Statements](index=4&type=section&id=Item%201.%20Interim%20Financial%20Statements) Presents Spectral AI, Inc.'s unaudited condensed consolidated financial statements, detailing financial position and performance [Unaudited Condensed Consolidated Balance Sheets](index=4&type=section&id=Unaudited%20Condensed%20Consolidated%20Balance%20Sheets%20as%20of%20June%2030%2C%202025%20and%20December%2031%2C%202024) **Unaudited Condensed Consolidated Balance Sheets (in thousands)** | Item | June 30, 2025 | December 31, 2024 | | :---------------------------------- | :------------ | :---------------- | | **Assets** | | | | Cash | $10,524 | $5,157 | | Accounts receivable, net | $1,467 | $2,505 | | Total current assets | $14,001 | $10,122 | | Total Assets | $16,009 | $12,095 | | **Liabilities and Stockholders' Deficit** | | | | Accounts payable | $1,986 | $4,035 | | Accrued expenses | $2,547 | $3,210 | | Warrant liabilities | $10,555 | $6,451 | | Total current liabilities | $16,186 | $17,644 | | Notes payable, long-term | $7,632 | $- | | Total Liabilities | $25,160 | $19,346 | | Total Stockholders' Deficit | $(9,151) | $(7,251) | | Total Liabilities and Stockholders' Deficit | $16,009 | $12,095 | [Unaudited Condensed Consolidated Statements of Operations and Comprehensive Loss](index=5&type=section&id=Unaudited%20Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss%20for%20the%20three%20and%20six%20months%20ended%20June%2030%2C%202025%20and%202024) **Unaudited Condensed Consolidated Statements of Operations and Comprehensive Loss (in thousands)** | Item | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :---------------------------------- | :------------------------------- | :------------------------------- | :------------------------------- | :------------------------------- | | Research and development revenue | $5,065 | $7,478 | $11,772 | $13,804 | | Gross profit | $2,290 | $3,314 | $5,458 | $6,259 | | Operating loss | $(2,123) | $(2,442) | $(3,019) | $(4,585) | | Change in fair value of warrant liability | $(5,449) | $348 | $(1,196) | $368 | | Net loss | $(7,968) | $(2,864) | $(5,071) | $(6,069) | | Net loss per share (Basic and Diluted) | $(0.31) | $(0.16) | $(0.21) | $(0.36) | [Unaudited Condensed Consolidated Statements of Changes in Stockholders' Deficit](index=6&type=section&id=Unaudited%20Condensed%20Consolidated%20Statements%20of%20Changes%20in%20Stockholders%27%20Deficit%20for%20the%20three%20months%20ended%20March%2031%2C%202025%20and%202024%2C%20and%20the%20three%20and%20six%20months%20ended%20June%2030%2C%202025%20and%202024) **Unaudited Condensed Consolidated Statements of Changes in Stockholders' Deficit (in thousands)** | Item | Balance at Dec 31, 2024 | Stock-based compensation | Issuance of Common Stock from debt offering | Issuance of common stock to pay convertible debt | Sale of common stock | Exercise of stock options | Cumulative translation adjustment | Net income/loss | Balance at June 30, 2025 | | :-------------------------- | :---------------------- | :----------------------- | :------------------------------------------ | :----------------------------------- | :------------------- | :---------------------- | :------------------------------ | :-------------- | :----------------------- | | Common Stock (Shares) | 22,594,877 | - | 2,028,846 | 610,426 | 310,925 | 43,047 | - | - | 25,737,820 | | Common Stock (Amount) | $2 | $- | $- | $- | $- | $- | $- | $- | $2 | | Additional Paid-in Capital | $40,973 | $200 | $377 | $1,433 | $543 | $158 | $- | $- | $44,095 | | Accumulated Other Comprehensive Income | $3 | $- | $- | $- | $- | $- | $49 | $- | $52 | | Accumulated Deficit | $(48,229) | $- | $- | $- | $- | $- | $- | $(5,071) | $(53,300) | | Total Stockholders' Deficit | $(7,251) | $611 | $377 | $1,433 | $543 | $158 | $49 | $(5,071) | $(9,151) | [Unaudited Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=Unaudited%20Condensed%20Consolidated%20Statements%20of%20Cash%20Flows%20for%20the%20six%20months%20ended%20June%2030%2C%202025%20and%202024) **Unaudited Condensed Consolidated Statements of Cash Flows (in thousands)** | Item | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :---------------------------------- | :----------------------------- | :----------------------------- | | Net cash used in operating activities | $(4,867) | $(8,042) | | Net cash provided by financing activities | $10,185 | $10,131 | | Effect of exchange rate changes on cash | $49 | $(2) | | Net increase in cash | $5,367 | $2,087 | | Cash, beginning of period | $5,157 | $4,790 | | Cash, end of period | $10,524 | $6,877 | [Notes to Unaudited Condensed Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) Detailed notes clarifying accounting policies, fair value, revenue, debt, and equity for the unaudited consolidated financial statements [Note 1. Nature of the Business and Presentation](index=8&type=section&id=1.%20NATURE%20OF%20THE%20BUSINESS%20AND%20PRESENTATION) Spectral AI, Inc. focuses on AI-driven burn wound diagnostics, generating government contract revenue and pursuing FDA approval for DeepView System - Spectral AI, Inc. is an **Artificial Intelligence (AI)** company focused on predictive medical diagnostics, with its **DeepView™ System** designed to assess burn wound healing potential[15](index=15&type=chunk) - The **DeepView System** received **UKCA marking** for burn indications in February 2024 and a De Novo application was filed with the **FDA** in June 2025 for **Class II medical device designation**[16](index=16&type=chunk) - The company currently generates revenue from **contract development and research services** for **governmental agencies** (primarily BARDA and MTEC) and has generated **no product revenue** to date[18](index=18&type=chunk)[19](index=19&type=chunk) - A new contract with BARDA in September 2023 provides up to **$150.0 million** in additional funding, including an initial **$54.9 million** for clinical validation, system distribution, and FDA submission[19](index=19&type=chunk) - **Liquidity Position (in thousands)** | Metric | June 30, 2025 | December 31, 2024 | | :------------------ | :------------ | :---------------- | | Cash | $10,524 | $5,157 | | Accumulated Deficit | $(53,300) | $(48,229) | | Debt Outstanding | $7,700 | $2,800 | - The company believes it has **sufficient working capital to fund operations for at least one year**, supported by the BARDA contract, MTEC Agreement, and Avenue Financing[45](index=45&type=chunk) - An immaterial correction of errors in prior period financial information resulted in a **$126,000** increase to both accumulated deficit and additional paid-in capital as of December 31, 2024 and 2023[26](index=26&type=chunk) - Accounts receivable and research and development revenue are highly concentrated, with one U.S. government agency representing **94% of net receivables** (June 30, 2025) and **92% of revenue** (three months ended June 30, 2025)[40](index=40&type=chunk)[41](index=41&type=chunk) [Note 2. Recent Accounting Pronouncements](index=12&type=section&id=2.%20RECENT%20ACCOUNTING%20PRONOUCEMENTS) Evaluates the impact of recent accounting standards, ASU 2023-09 (Income Taxes) and ASU 2024-03 (Expense Disaggregation), on financial statements - **ASU 2023-09 (Income Taxes)** requires **more detailed income tax disclosures**, effective for annual periods beginning after December 15, 2024[46](index=46&type=chunk) - **ASU 2024-03 (Expense Disaggregation Disclosures)** requires **additional information about specific expense categories**, effective for fiscal years beginning after December 15, 2026[47](index=47&type=chunk) [Note 3. Fair Value Measurements](index=13&type=section&id=3.%20FAIR%20VALUE%20MEASUREMENTS) Measures financial liabilities, primarily warrant liabilities, at fair value, with a significant increase due to Level 3 warrant changes - **Fair Value Measured as of June 30, 2025 (in thousands)** | Item | Fair value | Level 1 | Level 2 | Level 3 | | :------------------ | :--------- | :------ | :------ | :------ | | Warrant liabilities | $10,555 | $5,903 | $- | $4,651 | - **Fair Value Measured as of December 31, 2024 (in thousands)** | Item | Fair value | Level 1 | Level 2 | Level 3 | | :-------------------------- | :--------- | :------ | :------ | :------ | | Warrant liabilities | $6,451 | $6,409 | $- | $41 | | Short-term notes payable – Yorkville | $2,365 | $- | $- | $2,365 | - **Changes in Level 3 Liabilities Measured at Fair Value (in thousands)** | Period | Balance - January 1, 2025 | Fair value at issuance | Change in fair value | Balance - June 30, 2025 | | :-------------------------- | :---------------------- | :--------------------- | :------------------- | :---------------------- | | Six months ended June 30, 2025 | $41 | $2,908 | $1,702 | $4,651 | - Public Warrants were amended in November 2024 to have an exercise price of **$2.75 per share**, down from **$11.50**[52](index=52&type=chunk) - The company issued **2,068,846 Investor Warrants** in March 2025 with an exercise price of **$1.80 per share**, classified as liability instruments due to certain terms[54](index=54&type=chunk)[56](index=56&type=chunk) - As part of the Avenue Financing, **768,072 Avenue Warrants** were issued, classified as liability instruments, with an exercise price equal to the lower of **$1.66 per share** or the lowest price in future equity raises through December 31, 2025[58](index=58&type=chunk)[70](index=70&type=chunk) [Note 4. Research and Development Revenue](index=16&type=section&id=4.%20RESEARCH%20AND%20DEVELOPMENT%20REVENUE) Research and development revenue decreased for both three and six months ended June 30, 2025, primarily due to reduced BARDA contract activity - **Research and Development Revenue by Source (in thousands)** | Source | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :------------------------------ | :------------------------------- | :------------------------------- | :------------------------------- | :------------------------------- | | BARDA | $4,649 | $7,066 | $11,030 | $13,167 | | Other U.S. governmental authorities | $416 | $412 | $742 | $637 | | **Total revenue** | **$5,065** | **$7,478** | **$11,772** | **$13,804** | - **Contract Liabilities (Deferred Revenue, in thousands)** | Item | December 31, 2024 Balance | Additions | Reductions | June 30, 2025 Balance | | :----------------- | :------------------------ | :-------- | :--------- | :-------------------- | | Deferred revenue | $960 | $3,615 | $(4,151) | $424 | - Research and development expense for the six months ended June 30, 2025, was **$6.6 million**, down from **$9.7 million** in the comparable 2024 period[64](index=64&type=chunk) [Note 5. Accrued Expenses](index=16&type=section&id=5.%20ACCRUED%20EXPENSES) Accrued expenses decreased from December 31, 2024, to June 30, 2025, primarily due to reduced salary and wages - **Accrued Expenses (in thousands)** | Category | June 30, 2025 | December 31, 2024 | | :------------------ | :-------------- | :---------------- | | Salary and wages | $1,676 | $2,196 | | Operating expenses | $222 | $355 | | Benefits | $446 | $411 | | Non-operating expenses | $60 | $60 | | Taxes | $143 | $188 | | **Total accrued expenses** | **$2,547** | **$3,210** | [Note 6. Notes Payable](index=17&type=section&id=6.%20NOTES%20PAYABLE) Secured new long-term debt via Avenue Financing, including an initial draw-down and potential second tranche, while repaying Yorkville Convertible Notes - **Notes Payable Outstanding Balance (in thousands)** | Note Type | June 30, 2025 | December 31, 2024 | | :---------------------------------- | :------------ | :---------------- | | Avenue Capital Note Principal and Final Payment Fee | $9,250 | $- | | Yorkville Convertible Notes, at fair value | $- | $2,365 | | 2024 Insurance Note | $62 | $422 | | **Total Outstanding Balance** | **$9,312** | **$2,787** | | Less: current portion of notes payable | $(62) | $(2,787) | | Unamortized debt discounts and debt issuance costs | $(1,618) | $- | | **Notes payable, long term** | **$7,632** | **$-** | - The company completed the Avenue Financing on March 24, 2025, with an initial draw-down of **$8.5 million**[67](index=67&type=chunk) - The Avenue Financing has a three-year term, matures on March 1, 2028, and accrues interest at the greater of (i) Prime Rate + 5.25% or (ii) 12.75%; a final payment of **$0.8 million** is due at maturity[68](index=68&type=chunk) - A second financing tranche of **$6.5 million** under the Avenue Financing is contingent upon FDA clearance of the DeepView System and a **$7.0 million** equity raise[68](index=68&type=chunk)[131](index=131&type=chunk) - The remaining **$2.4 million** of Yorkville Convertible Notes were repaid during the six months ended June 30, 2025, with **$1.2 million** in cash and **$1.2 million** in common stock[72](index=72&type=chunk) [Note 7. Commitments and Contingencies](index=18&type=section&id=7.%20COMMITMENTS%20AND%20CONTINGENCIES) The company is not involved in any material legal proceedings or pending claims significantly impacting its business or financial condition - The Company is **not a party to any material legal proceedings or pending claims**[74](index=74&type=chunk) [Note 8. Stockholders' Deficit](index=18&type=section&id=8.%20STOCKHOLDERS%27%20DEFICIT) Following the Business Combination, the company's certificate of incorporation was amended to authorize common and preferred stock - The company's certificate of incorporation was amended to authorize **80 million shares of Common Stock** and **1 million shares of Preferred Stock**[75](index=75&type=chunk) [Note 9. Stock-Based Compensation](index=18&type=section&id=9.%20STOCK-BASED%20COMPENSATION) Recorded stock-based compensation expense, modified RSU awards, and granted new stock options, including those tied to stock price targets - **Stock-Based Compensation Expense (in thousands)** | Period | Three Months Ended June 30, 2025 | Six Months Ended June 30, 2025 | | :-------------------------- | :------------------------------- | :----------------------------- | | Stock-based compensation expense | $400 | $600 | - **Restricted Stock Unit (RSU) Activity (Six Months Ended June 30, 2025)** | Item | Number of Shares | Weighted Average Grant Date Fair Value per Share | | :-------------------------- | :--------------- | :--------------------------------------- | | Nonvested as of January 1, 2025 | 169,400 | $1.98 | | Vested | (109,700) | $1.82 | | Nonvested as of June 30, 2025 | 59,700 | $1.73 | - During the six months ended June 30, 2025, the company modified **150,000 RSU awards**, accelerating vesting for **100,000 awards** upon modification and **50,000 awards** to vest by December 31, 2025[78](index=78&type=chunk) - The company granted **550,000 stock options** that vest based on the 30-day VWAP meeting or exceeding **$3.00 per share**, and **360,434 stock options** that vest over a 1-year service period[80](index=80&type=chunk)[81](index=81&type=chunk) - Total unrecognized compensation expense related to stock options was **$1.0 million** (expected over 1.2 years) and for RSUs was **$85 thousand** (expected over 0.55 years) as of June 30, 2025[79](index=79&type=chunk)[82](index=82&type=chunk) [Note 10. Net Loss Per Common Share](index=20&type=section&id=10.%20NET%20LOSS%20PER%20COMMON%20SHARE) Excluded potentially dilutive securities from net loss per common share calculation due to their anti-dilutive effect - **Potentially Dilutive Securities Excluded from EPS Calculation (Six Months Ended June 30, in thousands)** | Security Type | 2025 | 2024 | | :------------------------ | :----- | :----- | | Common stock options | 4,408 | 3,931 | | Common stock warrants | 11,344 | 8,507 | | Unvested restricted stock units | 60 | 469 | | **Total** | **15,812** | **12,908** | [Note 11. Related Party Transactions](index=20&type=section&id=11.%20RELATED%20PARTY%20TRANSACTIONS) Spectral IP, a subsidiary, engaged in a related party note transaction, converting to common stock, and entered an IP license agreement with the Company - Spectral IP, a wholly-owned subsidiary, received a **$1.0 million** note payable investment from an affiliate of its largest stockholder in March 2024[87](index=87&type=chunk) - The Spectral IP Note was amended in October 2024 and fully converted into **540,996 shares of Common Stock** by the end of 2024[88](index=88&type=chunk) - In May 2025, Spectral IP received a **worldwide, non-exclusive license** to one international patent asset from the Company[89](index=89&type=chunk) - Spectral IP is undergoing a **reorganization** to acquire Sauvegarder Investment Management, Inc. by issuing Spectral IP common and preferred stock[90](index=90&type=chunk) [Note 12. Subsequent Events](index=20&type=section&id=12.%20SUBSEQUENT%20EVENTS) There were no subsequent events requiring disclosure [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=21&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management's discussion and analysis of Spectral AI's financial condition and operational results, covering business model, key metrics, liquidity, and future outlook [Overview](index=21&type=section&id=Overview) Spectral AI focuses on AI-driven burn wound diagnostics with DeepView System, completed a pivotal study, and generates government contract revenue - Spectral AI is an **AI company** focused on predictive medical diagnostics, with its **DeepView System** having received **FDA breakthrough device designation (BDD)** status, primarily for burn indications[93](index=93&type=chunk) - The company completed enrollment for its pivotal clinical study by the end of 2024, with **267 patients** across **22 sites** in burn centers and emergency departments[94](index=94&type=chunk) - Revenue is currently generated from contract development and research services for governmental agencies, including BARDA (up to **$150.0 million** new contract), MTEC (**$4.9 million** grant), and DHA[95](index=95&type=chunk)[96](index=96&type=chunk)[97](index=97&type=chunk) - Once commercialized, the DeepView System is anticipated to have two revenue streams: a **SaMD (software as a medical device)** model with a **SaaS licensing fee** and an **imaging device component**[98](index=98&type=chunk) [Key Operating and Financial Metrics](index=22&type=section&id=Key%20Operating%20and%20Financial%20Metrics) Monitors key metrics including R&D revenue, gross profit, net loss, and Adjusted EBITDA, showing improved performance for six months ended June 30, 2025 - **Key Operating and Financial Metrics (in thousands, except percentages)** | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------------- | :------------------------------- | :------------------------------- | :------------------------------- | :------------------------------- | | Research and development revenue | $5,065 | $7,478 | $11,772 | $13,804 | | Gross profit | $2,290 | $3,314 | $5,458 | $6,259 | | Gross margin | 45.2% | 44.3% | 46.4% | 45.3% | | Operating loss | $(2,123) | $(2,442) | $(3,019) | $(4,585) | | Net loss | $(7,968) | $(2,864) | $(5,071) | $(6,069) | | Adjusted EBITDA | $(1,712) | $(2,038) | $(2,396) | $(3,895) | - **Adjusted EBITDA** is defined as net loss excluding income taxes, depreciation, net interest income, stock compensation, transaction costs, and any non-operating financial income and expense[104](index=104&type=chunk) [Key Factors that May Influence Future Results of Operations](index=23&type=section&id=Key%20Factors%20that%20May%20Influence%20Future%20Results%20of%20Operations) Future results depend on U.S. governmental contract awards, commercialization pricing, and risks from supply chain disruptions and supplier concentration - The company's revenue is **almost exclusively dependent on existing and future U.S. governmental contract awards**, leading to potential inconsistency in operating results[106](index=106&type=chunk) - Commercial sales of the DeepView System may require **lower pricing and incentives** to accelerate adoption, which could **negatively impact future revenue and gross margin percentages**[107](index=107&type=chunk) - The company is **reliant on contract manufacturers and suppliers**, facing **risks of component shortages, delays, increased costs, and supply chain disruptions** due to supplier concentration[108](index=108&type=chunk) [Components of Consolidated Statements of Operations](index=24&type=section&id=Components%20of%20Consolidated%20Statements%20of%20Operations) Outlines primary components of consolidated statements of operations, including R&D revenue, cost of revenue, gross profit, operating costs, and other income/expense - Research and development revenue is the **primary source**, **highly dependent on reimbursements from BARDA and other U.S. governmental contract awards**[109](index=109&type=chunk) - Cost of revenues primarily consists of **direct and indirect costs associated with research and development expenses** related to BARDA and MTEC contracts[110](index=110&type=chunk) - Gross profit is affected by **fixed reimbursement rates** under government contracts and a **variable component** for non-reimbursed expenses[111](index=111&type=chunk) - Operating costs and expenses include **general and administrative expenses** (salaries, consulting, rent, insurance, office) and **non-revenue generating research and development expenses**[112](index=112&type=chunk) - Other income (expense) primarily includes **transaction costs**, net interest income, **changes in the fair value of warrant liabilities**, and **foreign exchange gains/losses**[113](index=113&type=chunk) [Results of Operations](index=25&type=section&id=Results%20of%20Operations) Experienced decreased R&D revenue and cost of revenue, improved gross margin, reduced G&A, but net loss widened due to warrant liability fair value changes - **Consolidated Results of Operations (in thousands)** | Item | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :---------------------------------- | :------------------------------- | :------------------------------- | :------------------------------- | :------------------------------- | | Research and development revenue | $5,065 | $7,478 | $11,772 | $13,804 | | Cost of revenue | $(2,275) | $(4,164) | $(6,314) | $(7,545) | | Gross profit | $2,290 | $3,314 | $5,458 | $6,259 | | General and administrative | $4,413 | $5,756 | $8,477 | $10,844 | | Operating loss | $(2,123) | $(2,442) | $(3,019) | $(4,585) | | Total other income (expense), net | $(5,864) | $(353) | $(2,000) | $(1,393) | | Net loss | $(7,968) | $(2,864) | $(5,071) | $(6,069) | - **Research and Development Revenue Change (in thousands, except percentages)** | Period | 2025 | 2024 | Change ($) | Change (%) | | :-------------------------- | :----- | :----- | :--------- | :--------- | | Three months ended June 30, | $5,065 | $7,478 | $(2,413) | -32.3% | | Six months ended June 30, | $11,772 | $13,804 | $(2,032) | -14.7% | - **Cost of Revenue Change (in thousands, except percentages)** | Period | 2025 | 2024 | Change ($) | Change (%) | | :-------------------------- | :----- | :----- | :--------- | :--------- | | Three months ended June 30, | $2,775 | $4,164 | $(1,389) | -33.4% | | Six months ended June 30, | $6,314 | $7,545 | $(1,231) | -16.3% | - **Gross Margin Change (percentage points)** | Period | 2025 | 2024 | Change (pp) | | :-------------------------- | :----- | :----- | :---------- | | Three months ended June 30, | 45.2% | 44.3% | +0.9% | | Six months ended June 30, | 46.4% | 45.3% | +1.1% | - **General and Administrative Expense Change (in thousands, except percentages)** | Period | 2025 | 2024 | Change ($) | Change (%) | | :-------------------------- | :----- | :----- | :--------- | :--------- | | Three months ended June 30, | $4,413 | $5,756 | $(1,343) | -23.3% | | Six months ended June 30, | $8,477 | $10,844 | $(2,367) | -21.8% | - The change in fair value of warrant liability decreased by approximately **$5.8 million** for the three months and **$1.6 million** for the six months ended June 30, 2025, compared to 2024, primarily due to the repricing of Public Warrants in November 2024[122](index=122&type=chunk) [Non-GAAP Financial Measures](index=27&type=section&id=Non-GAAP%20Financial%20Measures) Uses Adjusted EBITDA as a non-GAAP metric to evaluate performance, showing improved results for both three and six months ended June 30, 2025 - **Adjusted EBITDA Reconciliation (in thousands)** | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :---------------------------------- | :------------------------------- | :------------------------------- | :------------------------------- | :------------------------------- | | Net loss | $(7,968) | $(2,864) | $(5,071) | $(6,069) | | Depreciation expense | $- | $2 | $12 | $5 | | Provision for income taxes | $(19) | $69 | $52 | $91 | | Net interest (income) expense | $277 | $6 | $297 | $(8) | | **EBITDA** | **$(7,710)** | **$(2,787)** | **$(4,710)** | **$(5,981)** | | Stock-based compensation | $411 | $402 | $611 | $685 | | Borrowing related costs | $124 | $699 | $705 | $975 | | Change in fair value of warrant liability | $5,449 | $(348) | $1,196 | $(368) | | Change in fair value of notes payable | $- | $167 | $(220) | $101 | | Foreign exchange transaction loss | $14 | $9 | $22 | $25 | | Other (income) expenses, including transaction costs | $- | $(180) | $- | $668 | | **Adjusted EBITDA** | **$(1,712)** | **$(2,038)** | **$(2,396)** | **$(3,895)** | [Liquidity and Capital Resources](index=28&type=section&id=Liquidity%20and%20Capital%20Resources) As of June 30, 2025, the company had **$10.5 million** cash and **$7.7 million** notes payable, with sufficient working capital for one year, supported by BARDA and Avenue Financing - As of June 30, 2025, the company had **$10.5 million** in cash, **$7.7 million** in notes payable, and an accumulated deficit of **$53.3 million**[128](index=128&type=chunk) - The company believes it has **sufficient working capital for at least one year**, supported by the PBS BARDA Contract (up to **$150.0 million**) and the Avenue Financing (up to **$15.0 million**)[129](index=129&type=chunk)[130](index=130&type=chunk) - The Avenue Financing includes an initial draw-down of **$8.5 million** and a second tranche of **$6.5 million** contingent on FDA clearance of the DeepView System and a **$7.0 million** equity raise[130](index=130&type=chunk)[131](index=131&type=chunk) - As a condition to the Avenue Financing, the company raised an additional **$2.7 million** from the sale of **2,076,923 shares** of Common Stock at **$1.30 per share**[133](index=133&type=chunk) - **Cash Flows (Six Months Ended June 30, in thousands)** | Activity | 2025 | 2024 | | :---------------------------------- | :------- | :------- | | Net cash used in operating activities | $(4,867) | $(8,042) | | Net cash provided by financing activities | $10,185 | $10,131 | - Net cash used in operating activities decreased by approximately **$3.2 million**, primarily due to decreased staffing levels and consulting costs[136](index=136&type=chunk) - Net cash provided by financing activities **increased slightly** due to proceeds from the **Avenue Financing** and attendant **equity raise**, partially offset by **Yorkville debt repayments**[137](index=137&type=chunk) - A **material weakness** in financial statement close process controls has **not yet been remediated**, impacting the effectiveness of disclosure controls and procedures[158](index=158&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=32&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, Spectral AI acknowledges exposure to interest rate, foreign exchange, credit, and inflation risks - The company is a **smaller reporting company** and is **not required to provide quantitative and qualitative disclosures about market risk**[157](index=157&type=chunk) - The company is exposed to **interest rate, foreign exchange, credit, and inflation risks** in the ordinary course of business[151](index=151&type=chunk) - Interest rate sensitivity primarily affects the cost of future borrowings, as current notes are tied to **Prime plus 5%**[152](index=152&type=chunk) - **Credit risk is concentrated** in cash holdings (exceeding federally insured limits) and accounts receivable, with a majority from **one U.S. government agency**[154](index=154&type=chunk)[155](index=155&type=chunk) - **Inflationary pressures** on product, employee, or other costs could **adversely affect gross margin and selling, general, and administrative expenses**[156](index=156&type=chunk) [Item 4. Controls and Procedures](index=33&type=section&id=Item%204.%20Controls%20and%20Procedures) Disclosure controls and procedures were not effective due to an un-remediated material weakness in financial statement close process controls, with remediation efforts underway - Disclosure controls and procedures were **not effective** as of June 30, 2025, due to an un-remediated **material weakness** in financial statement close process controls[158](index=158&type=chunk) - The material weakness relates to **financial statement close process controls not consistently operating effectively** or lacking appropriate evidence for account reconciliations, transactions, and journal entries[158](index=158&type=chunk) - Remediation efforts include **engaging professional accounting services**, **strengthening and documenting accounting processes**, and **enhancing ERP system functionality**[163](index=163&type=chunk) - Despite the material weakness, management believes the condensed consolidated financial statements **fairly present the company's financial condition, results of operations, and cash flows**[159](index=159&type=chunk) Part II. Other Information [Item 1. Legal Proceedings](index=34&type=section&id=Item%201.%20Legal%20Proceedings) The company is not involved in any material legal proceedings or pending claims significantly affecting its business or financial condition - The Company is **not a party to any material legal proceedings or pending claims**[165](index=165&type=chunk) [Item 1A. Risk Factors](index=34&type=section&id=Item%201A.%20Risk%20Factors) No material changes to risk factors previously disclosed in the Annual Report on Form 10-K and Registration Statement on Form S-4 - There have been **no material changes** to the risk factors disclosed in the Annual Report on Form 10-K (March 31, 2025) and the Registration Statement on Form S-4 (January 5, 2024)[166](index=166&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=34&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) No unregistered sales of equity securities occurred; planned use of proceeds remains materially unchanged - **No unregistered sales of equity securities** occurred during the period[167](index=167&type=chunk) - There has been **no material change** in the planned use of proceeds from the Business Combination or the Avenue Financing[168](index=168&type=chunk) [Item 3. Defaults Upon Senior Securities](index=34&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) No defaults upon senior securities occurred during the period - **No defaults upon senior securities** occurred during the period[169](index=169&type=chunk) [Item 4. Mine Safety Disclosures](index=34&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) No disclosures related to mine safety were required - **No mine safety disclosures** were required[170](index=170&type=chunk) [Item 5. Other Information](index=34&type=section&id=Item%205.%20Other%20Information) No other information requiring disclosure was reported - **No other information requiring disclosure** was reported[171](index=171&type=chunk) [Item 6. Exhibits](index=35&type=section&id=Item%206.%20Exhibits) Lists exhibits filed with the Quarterly Report on Form 10-Q, including the Business Combination Agreement, officer certifications, and XBRL - Key exhibits include the **Business Combination Agreement**, certifications from the Principal Executive Officer and Chief Financial Officer, and **Inline XBRL documents**[173](index=173&type=chunk) Part III. Signatures - The report is signed by **J. Michael DiMaio, Principal Executive Officer**, and **Vincent S. Capone, Chief Financial Officer**, on August 12, 2025[178](index=178&type=chunk)[179](index=179&type=chunk)

Core Insights - Spectral AI, Inc. announced its Q2 2025 financial results and highlighted the successful submission of its De Novo application to the FDA for the DeepView System, marking a significant milestone for the company [2][3]. Financial Performance - Research & Development Revenue for Q2 2025 decreased by 32.0% to $5.1 million from $7.5 million in Q2 2024, attributed to the completion of clinical trials under the BARDA PBS Contract [5]. - Gross margin for Q2 2025 was 45.2%, slightly down from 46.6% in Q2 2024 due to increased non-reimbursed expenses related to the BARDA PBS Contract [6]. - General and administrative expenses in Q2 2025 were $4.4 million, down from $5.8 million, reflecting the company's focus on operational efficiencies [7]. - The company reported a net loss of $(7.9) million for Q2 2025, compared to a net loss of $(2.9) million in Q2 2024, primarily due to changes in the fair value of warrant liabilities [9]. - As of June 30, 2025, cash improved to $10.5 million from $5.2 million at the end of 2024, following a debt financing agreement of up to $15.0 million [10][11]. Business Highlights - The completion of the De Novo application submission to the FDA in June 2025 is a crucial step towards obtaining FDA approval for the DeepView System, aimed at enhancing clinical decision-making in wound care [3][10]. - The company reiterated its revenue guidance of approximately $21.5 million for FY 2025, excluding contributions from the DeepView System sales [12]. Company Overview - Spectral AI, Inc. focuses on AI-driven medical diagnostics, particularly in wound care, with the DeepView System designed to provide immediate assessments of burn wounds [14].

Core Insights - Spectral AI will report its financial results for Q2 2025 on August 12, 2025, after market close, followed by a conference call at 5:00 PM Eastern Time to discuss the results [1] Company Overview - Spectral AI, based in Dallas, focuses on AI-driven medical diagnostics, particularly in wound care, aiming for faster and more accurate treatment decisions [3] - The company is developing the DeepView System, a predictive device designed to provide clinicians with an objective assessment of a burn wound's healing potential before treatment [3] - The DeepView System aims to improve patient outcomes and reduce healthcare costs by offering algorithm-driven insights that exceed current standards of care [3]

Core Viewpoint - Spectral AI has submitted a De Novo 510k marketing clearance application to the FDA for its AI-driven DeepView® System, aimed at improving burn care through predictive assessments of healing potential [1][3]. Company Overview - Spectral AI, based in Dallas, focuses on predictive AI technology for medical diagnostics, particularly in wound care, with an emphasis on burn treatment [4]. - The DeepView System utilizes multi-spectral imaging and AI algorithms to provide non-invasive assessments of burn wounds, enabling timely and informed treatment decisions [2][4]. Product Details - The DeepView System is designed to predict the healing potential of burn wounds on the same day of injury and up to seven days post-injury, which can significantly enhance clinical decision-making [2][3]. - The technology is unique in the U.S. market, as there are currently no predicate devices available, necessitating the De Novo regulatory pathway for approval [1][3]. Regulatory Milestone - The submission of the De Novo request to the FDA is considered a major milestone for the company, marking a significant step towards bringing the DeepView System to the U.S. market [3]. - The project has received support from federal funds through the U.S. Department of Health and Human Services, indicating governmental backing for the development of this innovative technology [3].

Core Viewpoint - Spectral AI, Inc. is making significant advancements in burn care through its DeepView System, which enhances medical diagnostics and treatment decisions for wound care, as showcased at the British Burn Association conference [1][5][6]. Group 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 [7]. - The DeepView System aims to revolutionize wound care management by providing objective and immediate assessments of burn wounds' healing potential [7]. Group 2: Conference Highlights - The British Burn Association conference featured multiple presentations from Spectral AI, emphasizing the company's contributions to advancing burn care globally [1][5]. - Mr. Chris Wearn presented on the DeepView System, highlighting its potential to significantly improve acute burn care through its portability and AI-driven healing prediction capabilities [3][4]. - Dr. Jeffrey Carter reported promising results from early clinical experiences with DeepView, noting an increase in detection rates of non-healing wounds from 61% to 89% [5]. Group 3: Clinical Impact - The DeepView System has shown promising sensitivity and specificity results, enhancing clinicians' ability to assess burn wounds and improve patient outcomes [5]. - Feedback from clinicians at the conference indicates a positive impact of the DeepView System on clinical decision-making and patient care [6].

Company Overview - Spectral AI, Inc. is an artificial intelligence company focused on medical diagnostics, specifically aimed at improving treatment decisions in wound care [3] - The company is developing the DeepView System, a predictive device designed to provide clinicians with an objective assessment of a burn wound's healing potential [3] Leadership Change - Stanley Micek has been appointed as the Chief Operating Officer (COO) of Spectral AI, having previously served as Interim COO since May 2024 [1] - Micek's leadership has been recognized for his operational insight and ability to drive performance, particularly in overseeing the company's Research and Development efforts [1][2] Strategic Focus - The company aims to revolutionize wound care management by utilizing the DeepView System to exceed current standards of care, thereby improving patient outcomes and reducing healthcare costs [3] - Micek expressed enthusiasm about leading the operations team and emphasized the importance of the recent Pivotal Burn Study in driving the company's FDA submission efforts [3]