MDAI

Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Achieved FDA de novo clearance for the DeepView System burn indication, placing the technology in an exclusive tier of only 15% of breakthrough designated devices to reach market authorization. Transitioning from a development-stage organization to a commercial entity, supported by the appointment of a new Chief Commercial Officer with deep industry experience from Integra and Smith & Nephew. The DeepView System addresses a critical clinical gap by providing immediate assessment of burn healing potential, aiming to eliminate both surgical undertreatment and unnecessary grafting procedures. Management emphasizes a significant competitive moat protected by a proprietary library of over 340 billion pixels of clinically validated burn images and a robust patent portfolio. The commercial model utilizes a dual-revenue approach combining capital equipment sales or leases with recurring annual software and service contracts of at least three years. Operational focus is shifting toward a disciplined U.S. launch, leveraging long-standing clinical relationships from previous validation studies to accelerate the procurement cycle. Reiterated 2026 revenue guidance of approximately $18.5 million, primarily driven by BARDA funding and excluding significant contributions from initial DeepView sales. Planned deployment of the first 30 U.S. systems under the BARDA CLIN II contract through June 2027, which provides substantial non-dilutive funding for the initial installed base. Anticipate receiving expanded UKCA clearance in Q4 2026, enabling the commencement of international sales in the U.K., Australia, or Gulf Cooperation Council countries. Scheduled launch of a 12-center U.S. triage and treatment outcome study in Q4 2026 to quantify improvements in surgical precision and reductions in patient length of stay. Long-term strategy involves expanding the DeepView platform into new indications, including critical limb ischemia, diabetic foot ulcers, and total body surface area burn calculations. Maintained a strong liquidity position with $14 million in cash and access to over $60 million in additional non-dilutive BARDA funding. Secured a second $6.5 million tranche from the Avenue Capital facility, extending the interest-only period to 24 months with no principal payments due until March 2027. Reported a decline in R&D revenue and gross margins due to a deliberate shift into a cost-sharing phase with BARDA, co-investing in features with high commercial value. Completed a third-party pricing study indicating that commercial market pricing is expected to support margins significantly higher than current development-stage work. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here. The current sales force is led by the new Chief Commercial Officer and the head of U.K. operations, with plans to hire at least two additional personnel to support the Q4 2026 installation push. Management will personally assist in facilitating installations across clinical sites during the initial launch phase. Completed all requirements for the MTEC Department of War contract and delivered a prototype handheld device earlier this summer. Actively pursuing follow-on government funding for the 2026-2027 budget cycle and exploring commercial and military applications for the handheld technology. Identified new 'AI committees' and cybersecurity reviews as additional layers in the procurement process for centers without existing relationships. Expects faster adoption in centers with strong Key Opinion Leader (KOL) support where the company has conducted previous clinical validation work. Management characterized existing burn center technologies as either non-existent or 'antiquated,' positioning DeepView as a significant diagnostic leap. Noted that while Laser Doppler Imaging has some prevalence in the U.K., it has seen very little adoption in the U.S. market, leaving a clear opening for Spectral AI.

Company Continues to Advance Towards First Commercial Sales of the DeepView® System for Burn Indication Strong Cash Position of $14.0 Million at June 30, 2026 DALLAS, Aug. 11, 2026 (GLOBE NEWSWIRE) -- Spectral AI, Inc. (Nasdaq: MDAI) (“Spectral AI” or the “Company”), an artificial intelligence company focused on medical diagnostics for faster and more accurate treatment decisions in wound care, today announced financial results for the second quarter ended June 30, 2026 (“Q2 2026”). “Spectral AI has entered the second half of 2026 with tremendous momentum and a clear sense of purpose,” said Vincent Capone, Chief Executive Officer of Spectral AI. “The receipt of De Novo clearance from the U.S. Food and Drug Administration (“FDA”) for our DeepView® System for burn indication has cleared us to achieve our first commercial sales by year end 2026. We have made significant strides in the first half of this year by strengthening our leadership team, advancing our relationships with government and commercial partners, and fortifying our balance sheet. As we look ahead, we are excited by the scale of the opportunity before us. We remain strongly focused on our vision of supporting clinicians by bringing immediate, objective, and data-driven wound assessments that improve patient outcomes, and on the commercial delivery of our advanced, novel artificial intelligence technology to the marketplace.” Select Business Highlights In May 2026, received FDA clearance for the DeepView System for Burn Indication; with this classification, Spectral AI is now authorized to commence commercial distribution activities in the United States. In March 2026, awarded $31.7 million of advanced funding from the Biomedical Advanced Research and Development Authority (“BARDA”) to accelerate and support additional development and procurement for the DeepView System. Following the receipt of FDA clearance for the DeepView System, drew $6.5 million under our existing credit facility with Avenue Capital Group, providing non-dilutive capital to further strengthen the Company’s balance sheet. Expanded leadership team in advance of commercial activities, including the appointments of David McGuire as Chief Financial Officer and Darcy Bajko as Chief Commercial Officer. Completed all remaining milestones under our Department of Defense contract for the DeepView System handheld device, contracted through the Medical Technology Enterprise Consortium (“MTEC”), including the delivery of a fully functioning prototype device. Commenced label expansion of the DeepView System to include heads, hands and feet through an extended study based in the United Kingdom. Anticipated Operational and Commercial Milestones Generate first-ever commercial sales of the DeepView System in the U.S. by year end 2026. Complete UKCA authorization label expansion to reflect the FDA approved DeepView System for sales in either the United Kingdom, Australia, or Gulf Cooperation Council countries by year end 2026. Initiate Triage and Treatment Outcome Study in Q4 2026 to demonstrate that the DeepView System’s wound assessments improve surgical precision and accelerate treatment decisions, leading to a better overall patient care journey and reduced length of stay. 2026 Second Quarter (“Q2 2026”) Financial Results Overview All comparisons for Q2 2026 and the six months ended June 30, 2026 (“YTD 2026”) are to the comparable periods ended June 30, 2025 unless otherwise stated. Research & Development Revenue Research & Development revenue for Q2 2026 was $3.5 million compared to $5.1 million. The decline reflects the anticipated reduction in reimbursed costs under the Company’s Project BioShield contract with BARDA (the “BARDA PBS Contract”) following FDA clearance of the DeepView System, as the remaining scope of work narrowed to specific development projects. It also reflects the cost-share provisions of the follow-on development phase of that contract, under which the Company funds a portion of the development costs it incurs. Revenue from the Company’s other U.S. government contracts also declined as the Company completed performance under its MTEC contract. “We view the triggering of the cost-share component under our contract with BARDA as an indicator of program maturity,” said David McGuire, Spectral AI’s Chief Financial Officer. “It reflects the completion of the core development work of the DeepView System and FDA clearance of the device, while maintaining alignment with BARDA on the features expected to support commercial value. We are very excited to enter this next promising phase towards commercial revenues.” For YTD 2026, Research & Development revenue was $7.5 million compared to $11.8 million. The decline reflects the same reduction in reimbursed costs under the BARDA PBS Contract. This was partially offset by an increase in revenue from awards and work performed under the Company’s other U.S. government contracts, primarily related to work on the Company’s handheld device. Gross Margin Gross margin for Q2 2026 was 31.6%, down from 45.2%. The decline reflects the cost-share provisions of the follow-on development phase of the BARDA PBS Contract described above, under which the Company continues to incur development costs that are not fully reimbursable. A slightly lower realized margin on the Company’s fixed-fee MTEC contract also contributed to the reduction. For YTD 2026, gross margin was 41.8%, down from 46.4%. The decline primarily reflects the lower proportion of costs billed under the follow-on development phase of the BARDA PBS Contract. This was partially offset by the higher gross margin realized in the first quarter of 2026, prior to the commencement of that phase. Operating Expenses As we transition from mainly development activities to mixed development and commercial activities, we have disaggregated our reporting of G&A costs to break out development, sales and marketing and administrative costs in order to provide investors with clearer and more meaningful visibility of our evolving cost base. Operating expenses in Q2 2026 were $5.4 million, up 23.2% from $4.4 million. General and administrative expenses rose $0.5 million, primarily due to equity awards granted in the second quarter of 2026. Selling and marketing activities rose $0.3 million ahead of first commercial sales, including a third-party pricing study. Research and development activities rose $0.2 million. For YTD 2026, operating expenses were $9.4 million, up 11.3% from $8.5 million. Non-revenue generating research and development activities rose $0.5 million. General and administrative expenses rose $0.3 million, as higher stock-based compensation was partially offset by lower consultant fees. Selling and marketing activities rose $0.2 million. Total Other (Expense) / Income Total other income in Q2 2026 was $0.3 million compared to other expense of $(5.9) million. The change was due largely to the fair value of the Company’s warrant liability, which was a benefit of $0.7 million compared to an expense of $(5.4) million. For YTD 2026, total other expense was $(1.1) million compared to other expense of $(2.0) million. The change primarily relates to the fair value of the Company’s warrant liability, which was an expense of $(0.3) million compared to an expense of $(1.2) million. Net (Loss) Income Net loss for Q2 2026 was $(4.2) million, or $(0.13) per basic and diluted share, compared to net loss of $(8.0) million, or $(0.31) per basic and diluted share. The improvement was due primarily to the change in the fair value of the Company’s warrant liability noted above, partially offset by lower gross profit and higher operating expenses. For YTD 2026, net loss was $(7.6) million, or $(0.24) per basic and diluted share, compared to net loss of $(5.1) million, or $(0.21) per basic and diluted share. The increase primarily reflects lower gross profit and higher operating expenses, partially offset by lower total other expense. Adjusted EBITDA Adjusted EBITDA, a non-GAAP financial measure, was $(3.5) million for Q2 2026 compared to $(1.7) million, and $(5.2) million for YTD 2026 compared to $(2.4) million. Net loss, the most directly comparable GAAP measure, is presented above. See “Non-GAAP Financial Measures” below and the reconciliation of net loss to Adjusted EBITDA in the financial tables accompanying this press release. Financial Condition As of June 30, 2026, cash was $14.0 million compared to $15.4 million as of December 31, 2025. During Q2 2026, the Company drew $6.5 million under its existing credit facility with Avenue Capital Group, providing non-dilutive capital following the receipt of FDA clearance for the DeepView System. 2026 Guidance The Company is reiterating revenue of approximately $18.5 million for the year ending December 31, 2026, primarily reflecting the continued development of the Company’s DeepView System through the BARDA PBS Contract. This guidance does not include any material contributions from the sale of the DeepView System for the burn indication, which is anticipated by year end 2026, or further extensions or additional awards of our contract with MTEC. CONFERENCE CALL The Company will host a conference call today at 5:00 pm Eastern Time to discuss these results. Investors interested in participating in the live call can dial: 833-890-6620 – U.S. 412-564-3789 – International A simultaneous webcast of the call may be accessed online from the Events section of the Investor Relations page of the Company’s website at https://investors.spectral-ai.com/news-events/events. About Spectral AI Spectral AI, Inc. is a Dallas-based predictive AI company focused on medical diagnostics for faster and more accurate treatment decisions in wound care, with initial applications involving patients with burns. The Company is working to revolutionize the management of wound care by “Seeing the Unknown®” with its DeepView System. The DeepView System is a predictive diagnostic device that offers physicians an objective and immediate assessment of a wound’s healing potential prior to treatment or other medical intervention. With algorithm-driven results and a goal to exceed the current standard of care, the DeepView System provides fast and accurate treatment insights to improve patient outcomes and reduce healthcare costs. Spectral AI has been named to TIME’s list of World’s Top HealthTech companies 2025. For more information about the DeepView System, visit www.spectral-ai.com. Non-GAAP Financial Measures This release contains Adjusted EBITDA, a financial measure that is not calculated in accordance with generally accepted accounting principles in the United States (“GAAP”). The Company defines Adjusted EBITDA as net loss before income taxes, depreciation of property and equipment and net interest expense, further adjusted to exclude stock-based compensation, financing related costs, changes in the fair value of warrant liabilities and notes payable, foreign exchange transaction gains and losses, and transaction costs. Management uses Adjusted EBITDA to evaluate the Company’s operating performance, identify trends, prepare budgets and financial projections, and allocate resources. The Company believes Adjusted EBITDA is useful to investors because it excludes items that management does not consider indicative of core operating performance — principally non-cash remeasurements of the fair value of the Company’s warrant liabilities, which can fluctuate significantly from period to period based on the Company’s share price and are outside management’s control — thereby facilitating comparisons between periods and with other companies that report similar measures. The Company also excludes stock-based compensation because it is a non-cash expense whose amount in any period reflects the timing and size of equity awards and valuation inputs such as the Company’s share price at the date of grant, rather than the Company’s underlying operating activities, and can therefore vary significantly from period to period. Adjusted EBITDA has limitations as an analytical tool and should not be considered in isolation, or as a substitute for or superior to net loss or any other measure prepared in accordance with GAAP. Among other limitations, Adjusted EBITDA excludes net interest expense, which represents a recurring cash cost of the Company’s borrowings; excludes income taxes; excludes stock-based compensation, which is a recurring non-cash expense the Company expects to continue to incur and which is an important component of employee compensation; and does not reflect capital expenditures, working capital requirements or other cash requirements. Adjusted EBITDA is a performance measure and should not be construed as a measure of liquidity or of the cash flows generated by the Company’s operating, investing or financing activities. Because non-GAAP measures are not standardized, the Company’s Adjusted EBITDA may not be comparable to similarly titled measures reported by other companies. A reconciliation of net loss, the most directly comparable GAAP measure, to Adjusted EBITDA is included in the financial tables accompanying this release. Forward-Looking Statements Certain statements made in this release are “forward looking statements” within the meaning of the “safe harbor” provisions of the United States Private Securities Litigation Reform Act of 1995, including statements regarding the Company’s strategy, plans, objectives, initiatives and financial outlook. When used in this press release, the words “estimates,” “projected,” “expects,” “anticipates,” “forecasts,” “plans,” “intends,” “believes,” “seeks,” “may,” “will,” “should,” “future,” “propose” and variations of these words or similar expressions (or the negative versions of such words or expressions) are intended to identify forward-looking statements. These forward-looking statements are not guarantees of future performance, conditions or results, and involve a number of known and unknown risks, uncertainties, assumptions and other important factors, many of which are outside Company’s control, that could cause actual results or outcomes to differ materially from those discussed in the forward-looking statements. As such, readers are cautioned not to place undue reliance on any forward-looking statements. Investors should carefully consider the foregoing factors, and the other risks and uncertainties described in the “Risk Factors” sections of the Company’s filings with the US Securities and Exchange Commission, including the Company’s Annual Report on Form 10-K for the year ended December 31, 2025 and the other documents filed by the Company. These filings identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements. Investors: The Equity GroupDevin Sullivan, Managing [email protected] Conor Rodriguez, [email protected] Beginning on April 1, 2026, the Company changed the presentation of certain costs on its condensed consolidated statements of operations. This voluntary change in classification of certain research and development and selling and marketing costs resulted in a decrease in general and administrative expenses and offsetting increases in research and development and selling and marketing costs. This change in classification has been applied retrospectively to all periods presented and had no impact to revenue, cost of revenue, loss from operations, income (loss) before income taxes, income tax provision (benefit), net income (loss), earnings (loss) per common share, or other components of equity or cash flows.

Interested in Spectral AI, Inc.? Here are five stocks we like better. FDA clearance is shifting Spectral AI toward commercialization: The company plans a disciplined U.S. and international rollout of its DeepView burn-assessment system, including up to 30 U.S. placements supported substantially by BARDA through June 2027. It reiterated 2026 revenue guidance of approximately $18.5 million, excluding significant DeepView sales. Second-quarter results reflected lower development revenue but a narrower loss: R&D revenue fell to $3.5 million from $5.1 million, while net loss narrowed to $4.2 million, or $0.13 per share, from $8 million a year earlier. Gross margin declined to 31.6% and operating expenses rose to $5.4 million as the company prepared for launch. Liquidity and platform expansion remain priorities: Spectral AI ended June with $14 million in cash, $14.9 million in debt and access to more than $60 million in additional non-dilutive BARDA funding. It is also developing DeepView applications beyond burns, including critical ischemia, amputations and diabetic foot ulcers. Spectral AI (NASDAQ:MDAI) said its second-quarter results marked a transition toward commercial operations following the U.S. Food and Drug Administration’s De Novo clearance of its DeepView System for burn assessment in May. The company reiterated its 2026 revenue guidance of approximately $18.5 million, which does not assume significant revenue from DeepView system sales. Chief Executive Officer Vincent Capone said the FDA clearance enables Spectral AI to begin a disciplined commercial rollout in the United States and international markets. The company plans to focus on increasing clinician awareness, building commercial infrastructure, advancing its software and hardware, and pursuing additional tissue-diagnostic indications. → SoundHound AI Sends a Loud Signal After Its Q2 Earnings Beat Capone described DeepView as a first-of-its-kind AI-driven diagnostic imaging system designed to provide an immediate assessment of whether a burn wound is expected to heal independently or require significant medical intervention. He said the system’s assessment capabilities are supported by more than 340 billion pixels of clinically validated burn images. The FDA cleared the device through the De Novo pathway, which is used for novel devices without a predicate. Capone said Spectral AI received FDA Breakthrough Device designation in 2018 and that DeepView is among 193 devices that have obtained commercial market authorization through the De Novo process. → 3 Dividend Champion Utilities for a Market That Can't Sit Still The company’s commercial model is expected to include revenue from system capital purchases or leases, followed by recurring software and service revenue under minimum three-year terms. Capone said placements at prior clinical-study sites could move more quickly, while installations at new sites may face longer capital and procurement cycles. Spectral AI plans to deploy up to 30 DeepView systems at U.S. burn centers, trauma centers and emergency departments through June 30, 2027, under the CLIN2 component of its multiyear Project BioShield contract with the Biomedical Advanced Research and Development Authority, or BARDA. The first 30 U.S. placements are expected to receive substantial BARDA support. → Is Wingstop's Growth Story Losing Steam? During the question-and-answer session, Capone said the company currently has two commercial personnel: newly appointed Chief Commercial Officer Darcy Bajko and the head of its U.K. operations and overseas sales. Spectral AI has budgeted for at least two additional hires, he said. Bajko previously held roles at Integra and Smith+Nephew, according to Capone. He said her appointment is intended to support coordination across sales, marketing, market access and reimbursement efforts. Spectral AI is updating its U.K. Conformity Assessed, or UKCA, approval for burn assessment to incorporate the algorithm, hardware and software used in its FDA-cleared device. The company expects the expanded UKCA clearance in the fourth quarter of 2026, after which it plans to begin initial placements or sales in the United Kingdom, Australia or Gulf Cooperation Council countries. Capone said the company has conducted device evaluations in Australia and the U.K. and expects those markets, along with one or two U.K. centers, to represent the earliest international installations. He also said the company sees potential opportunities in other regions but did not provide details. In the U.K., Spectral AI has initiated a Head, Hands, and Feet study intended to support a label expansion across markets. In the U.S., the company expects to launch a 12-center triage and treatment outcome study in the fourth quarter of 2026. The study is designed to show that DeepView assessments can improve surgical precision, accelerate treatment decisions and reduce patient length of stay. Capone said procurement remains a key deployment hurdle, particularly at sites where Spectral AI has less-established relationships. New installations can require navigation of procurement, cybersecurity and AI-related review committees. However, he said the company believes it can meet its BARDA and internal rollout timelines, particularly at sites supported by key opinion leaders and prior clinical-study relationships. Chief Financial Officer David McGuire reported second-quarter research and development revenue of $3.5 million, down from $5.1 million in the year-earlier period. He attributed the decline to BARDA’s move into a cost-sharing phase, completion of burn validation work and the completion of work under the company’s Medical Technology Enterprise Consortium, or MTEC, contract. Gross margin was 31.6% in the second quarter, compared with 45.2% a year earlier. Operating expenses increased to $5.4 million from $4.4 million. Net loss narrowed to $4.2 million, or $0.13 per basic and diluted share, from $8 million, or $0.31 per share, a year earlier. Total other income was $300,000, compared with other expense of $5.9 million in the prior-year quarter, primarily due to non-cash warrant-liability fair-value adjustments. McGuire said the company changed its expense presentation to separately report research and development, sales and marketing, and general and administrative costs. Research and development expense increased by $200,000 to $1.7 million, while selling and marketing expense rose by $300,000 to $700,000 as the company prepared for launch. General and administrative expense increased by $500,000 to $3.1 million, primarily due to non-cash stock compensation. The company completed a third-party pricing study during the quarter. McGuire said preliminary customer discussions indicate potential pricing that could support margins above those generated by its development work, though the company expects to refine pricing as commercialization progresses. As of June 30, Spectral AI had $14 million in cash, compared with $15.4 million at the end of 2025, and total debt of $14.9 million. In June, the company drew the second $6.5 million tranche under its Avenue Capital facility, bringing total borrowings under the facility to $15 million. FDA clearance triggered an extension of the facility’s interest-only period to 24 months, with no principal payments due through March 2027 and maturity in March 2028, McGuire said. The company also cited access to more than $60 million in additional non-dilutive BARDA funding and an available equity facility with Yorkville. Beyond burns, Spectral AI is developing DeepView as a platform technology. Capone said the company delivered a handheld-device prototype to MTEC during the prior quarter and has completed all work under that contract. MTEC is evaluating its 2026 and 2027 budget allocations, while Spectral AI continues to see possible commercial and military applications for the handheld technology. The company is also working on technology to calculate total body surface area affected by burns and is evaluating potential future indications including critical ischemia, amputations and diabetic foot ulcers. Spectral AI, Inc (NASDAQ: MDAI) is a technology company focused on delivering advanced analytics and insights through the application of machine learning to multi-spectral and hyperspectral data. Its core platform ingests imagery from satellites, aerial drones and ground-based sensors, applying proprietary algorithms to identify patterns and anomalies invisible to the naked eye. The company's solutions are designed to help clients make more informed decisions in areas such as agriculture, environmental monitoring, infrastructure inspection and resource exploration. The company offers a cloud-native software-as-a-service (SaaS) platform that enables users to visualize and analyze large volumes of spectral data via customizable dashboards. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "Spectral AI Q2 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for August 2026.

DALLAS, July 29, 2026 (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 that it will report financial results for the second quarter ended June 30, 2026 on Tuesday, August 11, 2026, after the close of the Nasdaq stock market. The Company will host a corresponding conference call at 5:00 pm Eastern Time on the same day to discuss its financial results. Investors interested in participating in the live call can dial into the conference call as follows: 833-890-6620 – U.S. 412-564-3789 – International In addition, a simultaneous webcast of the financial results call may be accessed online from the Events section of the Investor Relations page of the Company’s website at https://investors.spectral-ai.com/news-events/events. About Spectral AISpectral AI, Inc. is a Dallas-based predictive AI company focused on medical diagnostics for faster and more accurate treatment decisions in wound care, with initial applications involving patients with burns. The Company is working to revolutionize the management of wound care by “Seeing the Unknown®” with its DeepView System. The DeepView System is a predictive diagnostic device that offers physicians an objective and immediate assessment of a wound’s healing potential prior to treatment or other medical intervention. With algorithm-driven results and a goal to exceed the current standard of care, the DeepView System provides fast and accurate treatment insights to improve patient outcomes and reduce healthcare costs. Spectral AI has been named to TIME’s list of World’s Top HealthTech companies 2025. For more information about the DeepView System, visit www.spectral-ai.com. Forward-Looking Statements Certain statements made in this release are “forward looking statements” within the meaning of the “safe harbor” provisions of the United States Private Securities Litigation Reform Act of 1995, including statements regarding the Company’s strategy, plans, objectives, initiatives and financial outlook. When used in this press release, the words “estimates,” “projected,” “expects,” “anticipates,” “forecasts,” “plans,” “intends,” “believes,” “seeks,” “may,” “will,” “should,” “future,” “propose” and variations of these words or similar expressions (or the negative versions of such words or expressions) are intended to identify forward-looking statements. These forward-looking statements are not guarantees of future performance, conditions or results, and involve a number of known and unknown risks, uncertainties, assumptions and other important factors, many of which are outside Company’s control, that could cause actual results or outcomes to differ materially from those discussed in the forward-looking statements. As such, readers are cautioned not to place undue reliance on any forward-looking statements. Investors should carefully consider the foregoing factors, and the other risks and uncertainties described in the “Risk Factors” sections of the Company’s filings with the US Securities and Exchange Commission, including the Company’s Registration Statement and the other documents filed by the Company. These filings identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements.

Provides Update and Outlook Following Receipt of FDA De Novo Clearance for DeepView® System for Burn Indication DALLAS, June 01, 2026 (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 results from its 2026 Annual Meeting of Stockholders, held on May 29, 2026. The Company also provided an overview of its accomplishments to date and targeted milestones for 2026 following the receipt of De Novo Classification for its DeepView® System from the U.S. Food and Drug Administration (“FDA”). 2026 Annual Meeting of Stockholders A total of 17,267,570 shares representing 54.3% of the Company’s total shares outstanding were represented at the meeting, either in person or by proxy. All three of the proposals set forth by the Company were approved by its stockholders. The voting results are detailed below. Five directors were elected to serve on the Company’s Board of Directors until the next Annual Meeting of Stockholders: Dr. J. Michael DiMaio, MD, a founder of the Company and Chairman of the Board of Directors Richard Cotton, Chairman of the Company’s Audit Committee and Lead Independent Director Marion Snyder, Zone Vice President, Strategic Accounts, at Shockwave Medical The Company’s stockholders also ratified the appointment of Forvis Mazars, LLP as the Company’s independent registered public accounting firm for the 2026 fiscal year and authorized the reservation and issuance of shares of common stock pursuant to a Securities Purchase Agreement dated October 24, 2025. A New Chapter for Spectral AI “The receipt of FDA clearance for our DeepView System for Burn Indication is the culmination of years of hard work by our dedicated team and a defining moment in Spectral AI’s history,” said Vincent Capone, Chief Executive Officer. “Spectral AI is now poised to evolve from a late stage, pre-clearance medical device company to a scaling, commercially focused enterprise. We are moving forward with renewed momentum and a clear vision for the future.” Key 2026 Operational and Business Achievements Received FDA clearance for the DeepView System for Burn Indication; with this classification, Spectral AI is now authorized to commence commercial distribution activities in the United States. Awarded $31.7 million of advanced funding from the Biomedical Advanced Research and Development Authority (“BARDA”) to accelerate and support additional feature aspects for the DeepView System. Expanded leadership team in advance of commercial activities, including the recent appointment of David McGuire as Chief Financial Officer. Delivered a fully functioning prototype of our Deep View System handheld device under our Department of Defense contract through the contracting consortium called MTEC. Finalized the development of the Outcome Study, which will focus on the benefits derived from the use of the DeepView System across clinician workflows and patients’ journeys with an intended scope of approximately 286 patients spread across 12 clinical sites. Showcased the DeepView System at this year’s Annual Meeting of the American Burn Association (“ABA”), which included an overview of the technology to attendees at the ABA Innovation Theater. Received the “Small Business Innovator Award” at the inaugural Texas Innovation Conference, which was held in April 22-23, 2026 at the campus of Texas Christian University. Anticipated Operational and Commercial Milestones Generate first-ever commercial sales of the DeepView System by year end 2026: Continue to strengthen executive and sales team by filling key positions to support the commercial roll out of the DeepView System. Initiate Outcome Study in the fourth quarter of 2026. The Study is designed to demonstrate the surgical precision that results from a wound assessment made by the DeepView System and how improved time to treatment decisions will beneficially impact a patient’s overall care journey. About the DeepView System Spectral AI's DeepView System is a non-invasive, predictive medical device which combines multispectral imaging with a proprietary AI algorithm to assess the healing potential of areas within the burn wounds. The DeepView System provides clinicians with an immediate, data-driven assessment of whether areas within burn wounds are unlikely to heal within 21 days and may require significant medical intervention, enabling earlier and more informed treatment decisions.   The image acquisition takes 0.2 seconds, and all image processing and AI model classification takes approximately 20 to 25 seconds. The DeepView System is trained and tested against a proprietary and clinically validated database of over 340 billion pixels of burn wound image data. About Spectral AI Spectral AI, Inc. is a Dallas-based predictive AI company focused on medical diagnostics for faster and more accurate treatment decisions in wound care, with initial applications involving patients with burns. The Company is working to revolutionize the management of wound care by “Seeing the Unknown®” with its DeepView System. The DeepView System is being developed as a predictive diagnostic device to offer clinicians an objective and immediate assessment of a burn wound’s healing potential prior to treatment or other medical intervention. With algorithm-driven results and a goal of exceeding the current standard of care in the future, the DeepView System is expected to provide fast and accurate treatment insight towards value care by improving patient outcomes and reducing healthcare costs. Spectral AI has been named to TIME’s list of World’s Top HealthTech companies 2025. For more information about the DeepView System, visit www.spectral-ai.com. Forward-Looking Statements Certain statements made in this release are “forward looking statements” within the meaning of the “safe harbor” provisions of the United States Private Securities Litigation Reform Act of 1995, including statements regarding the Company’s strategy, plans, objectives, initiatives and financial outlook. When used in this press release, the words “estimates,” “projected,” “expects,” “anticipates,” “forecasts,” “plans,” “intends,” “believes,” “seeks,” “may,” “will,” “should,” “future,” “propose” and variations of these words or similar expressions (or the negative versions of such words or expressions) are intended to identify forward-looking statements. These forward-looking statements are not guarantees of future performance, conditions or results, and involve a number of known and unknown risks, uncertainties, assumptions and other important factors, many of which are outside Company’s control, that could cause actual results or outcomes to differ materially from those discussed in the forward-looking statements. As such, readers are cautioned not to place undue reliance on any forward-looking statements. Investors should carefully consider the foregoing factors, and the other risks and uncertainties described in the “Risk Factors” sections of the Company’s filings with the US Securities and Exchange Commission, including the Company’s Registration Statement and the other documents filed by the Company. These filings identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements. Investors: The Equity Group Devin SullivanManaging [email protected] Conor [email protected]

By John Vandermosten, CFA NASDAQ: MDAI READ THE FULL MDAI RESEARCH REPORT Spectral AI, Inc. (NASDAQ: MDAI) reported first quarter 2026 results on May 12th after the market close. Since the previous financial update about a month and a half ago, the company has appointed David McGuire as Chief Financial Officer (CFO), presented DeepView at the American Burn Association, and received the Small Business Innovator Award in Texas. CEO Vincent Capone also participated in a podcast discussing DeepView’s opportunities, where he identified some of the company’s long-term objectives. During its earnings presentation, the company reaffirmed 2026 research and development revenue guidance of $18.5 million. The guidance excludes product revenues. Spectral believes there will be deployments inside and outside the United States in 2026. It plans to update its United Kingdom Conformity Assessed (UKCA) burn assessment mark approval to reflect improvements, which could lead to UK sales after the updated labeling. Back stateside, Spectral confirmed that a prototype handheld version of DeepView was delivered to MTEC for review. It expects that if the agency accepts the device, MTEC may award another grant in December 2026. The search for a Chief Commercial Officer continues, and we think that an appointment could be announced in the next month. 1Q:26 Financial and Operational Results Spectral reported 1Q:26 results in a press release on May 12th, followed by a conference call to discuss results with investors and take questions from analysts. A Form 10-Q was subsequently filed with the SEC. For the quarter ending March 31st, 2026, Spectral recognized research and development revenues of $4.0 million. Net loss from operations was $2.0 million. For 1Q:26 versus the same, prior year period: Revenues of $4.0 million fell 40% from $6.7 million, reflecting a reduction in direct labor, clinical trial, and other reimbursed study costs related to the BARDA contract. This was partially offset by work on other contracts, including the Medical Technology Enterprise Consortium (MTEC) for the handheld device; Cost of revenue, which can be thought of as research and development expense, totaled $2.0 million, down 45% from $3.5 million due to decreased development activity. Gross margin rose 356 basis points to 50.8%, reflecting a higher concentration of direct labor as a percentage of the total work performed on the BARDA Project BioShield (PBS) Contract from the prior year; General & Administrative expenses were $4.0 million, down 2% from $4.1 million on overall cost reductions partially offset by an increase in public company infrastructure costs; Net interest expense was $258,000 compared to $20,000, with the increase related to the Avenue Capital financing and insurance policy financing; Other expense of $1.2 million was attributable to a change in fair value of warrants and the amortization of the discount on the Avenue notes payable; Income tax benefit was $10,000 vs. an expense of $71,000; Net loss was $3.4 million or $0.11 per share vs net income of $2.9 million and $0.15 per share. As of March 31st, 2026, cash totaled $11.7 million. This amount compares to the $15.4 million cash balance held at the end of 2025. Cash burn in the quarter was $3.7 million, and cash flow from financing was insignificant. Addition of New CFO David McGuire steps into the CFO role at Spectral following the elevation of Vincent Capone to CEO. A press release issued on April 8th, 2026, announced David’s appointment. Mr. McGuire has 20 years of experience in finance and accounting roles. Prior to joining Spectral AI, he served as the Chief Accounting Officer of Solo Brands, a publicly traded consumer products company, where he was responsible for overseeing the accounting, financial reporting, internal controls, and tax functions, while also supporting broader finance and operational initiatives to scale its public company infrastructure. He also served as Deputy CFO and Chief Accounting Officer of EZCORP, a multi-national, publicly traded provider of consumer retail transactions and consumer financial services, where he was responsible for financial operations and played a key role in capital markets activities and broader strategic initiatives. Mr. McGuire was a Managing Director at a professional services company where he built the firm’s Texas practice and advised growing companies on finance and accounting transformation. He began his career at Ernst & Young, where he assumed positions of increasing responsibility over a 14-year career. He holds a Bachelor of Business Administration and a Master’s in Professional Accounting from The University of Texas at Austin and is a Certified Public Accountant. American Burn Association Annual Meeting Spectral AI and its representatives attended the American Burn Association (ABA) Annual Meeting held in Orlando, Florida, from April 14th to 17th, 2026. This event brings together many of the most important leaders and stakeholders in the burn care education, research, and practice from around the world. Spectral brought along its DeepView System to display to attendees. Dr. Christopher Lewis, the lead investigator and author on evaluations of the device, also joined the conference. He provided a review of DeepView and real-world observations of its use in emergency practice. Spectral engaged with prospectively interested parties, including the military, during the conference. As a follow-up to this event, CEO Vince Capone noted that he would be attending the Institute of Strategic Research conference next month, which is heavily attended by Department of Defense representatives. This should provide another opportunity to share the DeepView device with interested parties. As part of the meeting, Spectral offered several podium and poster presentations, which we list below: Podium Presentations Evaluation of Triage Patterns of Burn-Injured Patients Using the BEACON Model (Dr. Taryn Travis). The First Reader Study of Burn Wounds with Predictive Artificial Intelligence Analysis (Dr. Alisa Savetamal) Artificial Intelligence - Enhanced Multispectral Imaging for Burn Wound Assessment: Pilot Evaluation of Complex Anatomical Sites (Dr. Shreyas Supparamaniam) Advancements in Burn Size Assessment: A Systematic Review of Emerging Technologies (Dr. Amy Woods) Poster Presentations Exploring Patient Experiences of Decision-Making Around Skin Graft Surgery Using an AI Burn Assessment Tool (Dr. Zoe Gotts) Artificial Intelligence-Enhanced Multispectral Imaging for Burn Wound Assessment: A Multi-Centre UK Evaluation update (Dr. Leslie Tan) Usability of an Artificial Intelligence-Enhanced Multispectral Imaging Tool for Burn Assessment: A Retrospective Heuristic Evaluation (Dr. Hajar Abdulla) Product Update During the first quarter conference call, CEO Vince Capone guided towards a mid-year response from the FDA. In the meantime, the team will be focused on pre-commercialization activities. Despite the departure of the company’s Chief Commercial Officer earlier this year, Spectral is conducting a search to identify a new one. We think that an appointment could be announced in the near term. In parallel, the company will engage Deloitte Consulting to help with the strategic plan for commercialization and expects sales inside and outside of the BARDA universe this year. Spectral plans to structure the implementations as multi-year contracts that provide for software upgrades, product licensing, and device maintenance. Spectral will receive help from the BARDA contract, which will fund device deployment. SnapShot, a handheld version of DeepView, is undergoing additional testing for durability on the battlefield for the Department of Defense. The device offers civilian applications, and Spectral management is in discussions with authorities for its use in public settings such as ambulances. Management expects that regulatory clearance for SnapShot will follow the faster 510(k) pathway, relying on the DeepView device as a predicate. Spectral achieved a near-term milestone for SnapShot and delivered a fully functioning prototype of the handheld device in early May. The Medical Technology Enterprise Consortium (MTEC) will consider the device and application, and could grant another award by year end. For DeepView, further research and development work is expected, including a label expansion to image and diagnose burns on the head, hands, and feet. Spectral may also pursue a new indication, which may be in critical limb ischemia or amputations. Partnerships could also be developed for work in wound care. Despite federal funding uncertainties, Spectral announced $31.7 million of BARDA funding that will accelerate the development of DeepView. The company will augment this funding with another $9.7 million to support additional features for the device. Spectral AI CEO Podcast Spectral AI CEO Vincent Capone discusses the key factors driving the value of the company. The conversation touches on the $32 million BARDA award, 2026 revenue guidance, the handheld device, and expectations for unit deployments assuming approval occurs in the next weeks. Follow the embedded link for the full episode. SUBSCRIBE TO ZACKS SMALL CAP RESEARCH to receive our articles and reports emailed directly to you each morning. Please visit our website for additional information on Zacks SCR. DISCLOSURE: Zacks SCR has received compensation from the issuer directly, from an investment manager, or from an investor relations consulting firm, engaged by the issuer, for providing research coverage for a period of no less than one year. Research articles, as seen here, are part of the service Zacks SCR provides and Zacks SCR receives payments totaling a maximum fee of up to $50,000 annually for these services provided to or regarding the issuer. 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Development Work for DeepView® Systems Continues with Support of Recently Awarded $31.7 Million of Funding from BARDA Reiterates Annual Revenues Guidance DALLAS, May 12, 2026 (GLOBE NEWSWIRE) -- Spectral AI, Inc. (Nasdaq: MDAI) (“Spectral AI” or the “Company”), an artificial intelligence company focused on medical diagnostics for faster and more accurate treatment decisions in wound care, today announced financial results for the first quarter ended March 31, 2026. “Our results for the 2026 first quarter reflected the progress we have made in developing our DeepView® System for burn indication under the base phase of our Project BioShield Contract with BARDA,” said Vincent Capone, Chief Executive Officer of Spectral AI. “The work we have completed under this base phase – which was ongoing in last year’s first quarter - allowed us to submit our De Novo 510(k) application to the U.S. Food and Drug Administration (“FDA”) for the DeepView System in June 2025. As we await determination on market authorization from the FDA, we are furthering the development of the DeepView System under an accelerated second phase of our contract with BARDA that includes $31.7 million of advanced, non-dilutive funding.” Mr. Capone concluded, “Our financial condition remains strong, and we continue to make investments that align with our strategic priorities and in advance of planned commercialization activities. One such priority was to strengthen our leadership team, and I am happy to once again welcome David McGuire as the Company’s Chief Financial Officer. David brings a wealth of relevant public company experience to his role at Spectral AI and his appointment helps bolster our leadership team for the next exciting phase of our growth.” 2026 FIRST QUARTER (“Q1 2026”) FINANCIAL RESULTS OVERVIEW All comparisons to Q1 2026 are to the comparable period ended March 31, 2025 unless otherwise stated. Research & Development Revenue Research & Development revenue for Q1 2026 was $4.0 million compared to $6.7 million, reflecting the anticipated decline in completed work under the base phase of the Company’s Project BioShield (PBS) contract with the Biomedical Advanced Research and Development Authority (BARDA). This was partially offset by an increase in revenue from awards and work performed under the Company’s other U.S. government contracts, primarily related to work on the Company’s handheld device. Gross Margin Gross margin for Q1 2026 was 50.8% compared to 47.2%, due primarily to an increased concentration of direct labor as a component of overall revenue. General & Administrative Expense General and administrative expenses in Q1 2026 were $4.0 million, down from $4.1 million reflecting an overall decrease in administrative expense offset by an increase in non-revenue generating R&D activities, primarily related to salaries and related costs and consulting fees. Toal Other (Expense) / Income Total other expense in Q1 2026 was $(1.5) million compared to other income of $3.9 million. This was due largely to a change in fair value of warrant liability, which was an expense of $(1.0) million in Q1 2026 as compared to a benefit of $4.3 million. Net (Loss) Income Net loss for Q1 2026 was $(3.4) million, or $(0.11) per diluted share, compared to net income of $2.9 million, or $0.11 per diluted share primarily related to a change in the fair value of the Company’s warrant liability. Financial Condition As of March 31, 2026, cash was $11.7 million compared to $15.4 million as of December 31, 2025. 2026 Guidance The Company is forecasting revenue of approximately $18.5 million for the year ending December 31, 2026, primarily reflecting the continued development of the Company’s DeepView System through the BARDA PBS Contract. This guidance does not include any material contributions from the sale of the DeepView System for the burn indication. CONFERENCE CALL The Company will host a conference call today at 5:00 pm Eastern Time to discuss these results. Investors interested in participating in the live call can dial: 833-890-6620 – U.S. 412-564-3789 – International A simultaneous webcast of the call may be accessed online from the Events section of the Investor Relations page of the Company’s website at https://investors.spectral-ai.com/news-events/events. About Spectral AI Spectral AI, Inc. is a Dallas-based predictive AI company focused on medical diagnostics for faster and more accurate treatment decisions in wound care, with initial applications involving patients with burns. The Company is working to revolutionize the management of wound care by “Seeing the Unknown®” with its DeepView System. The DeepView System is being developed as a predictive diagnostic device to offer clinicians an objective and immediate assessment of a burn wound’s healing potential prior to treatment or other medical intervention. With algorithm-driven results and a goal of exceeding the current standard of care in the future, the DeepView System is expected to provide fast and accurate treatment insight towards value care by improving patient outcomes and reducing healthcare costs. Spectral AI has been named to TIME’s list of World’s Top HealthTech companies 2025. For more information about the DeepView System, visit www.spectral-ai.com. Forward-Looking Statements Certain statements made in this release are “forward looking statements” within the meaning of the “safe harbor” provisions of the United States Private Securities Litigation Reform Act of 1995, including statements regarding the Company’s strategy, plans, objectives, initiatives and financial outlook. When used in this press release, the words “estimates,” “projected,” “expects,” “anticipates,” “forecasts,” “plans,” “intends,” “believes,” “seeks,” “may,” “will,” “should,” “future,” “propose” and variations of these words or similar expressions (or the negative versions of such words or expressions) are intended to identify forward-looking statements. These forward-looking statements are not guarantees of future performance, conditions or results, and involve a number of known and unknown risks, uncertainties, assumptions and other important factors, many of which are outside Company’s control, that could cause actual results or outcomes to differ materially from those discussed in the forward-looking statements. As such, readers are cautioned not to place undue reliance on any forward-looking statements. Investors should carefully consider the foregoing factors, and the other risks and uncertainties described in the “Risk Factors” sections of the Company’s filings with the SEC, including the Registration Statement and the other documents filed by the Company. These filings identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements.

Interested in Spectral AI, Inc.? Here are five stocks we like better. Spectral AI said it remains on track for FDA clearance of its DeepView burn assessment system, with a response expected by the end of Q2 2026 and a goal of commercializing in late 2026 if approved. The company received $31.7 million in BARDA funding, which will support product development and deployment, but management said most of the revenue recognition is expected in 2027 rather than 2026. First-quarter R&D revenue fell to $4.0 million from $6.7 million a year earlier as base BARDA contract work ended, though that was partly offset by other government contract activity and an improved gross margin of 50.8%. Spectral AI (NASDAQ:MDAI) said it remains on track toward potential U.S. regulatory clearance and commercialization of its DeepView system for burn assessment, while reporting lower first-quarter research and development revenue tied to the completion of work under a federal contract. On the company’s first-quarter 2026 earnings call, Chief Executive Officer Vincent Capone said the period was defined by “progress and preparation,” citing ongoing discussions with the U.S. Food and Drug Administration, expanded government funding and steps toward building a commercial infrastructure. → MercadoLibre Boldly Invests in Growth: Discount Deepens Spectral AI submitted its De Novo application to the FDA in June 2025 for the DeepView system. Capone said the company has responded to additional information requests and “maintained an active dialogue” with the agency. The company continues to expect a response before the end of the second quarter of 2026. “I think that we're in as good a position as we can be, and I think our timeline has remained solid,” Capone said during the question-and-answer portion of the call. → Rocket Lab Just Hit a New All-Time High—Time to Buy or Let It Breathe? Capone said Spectral AI hopes to move quickly to commercialize DeepView by the end of 2026 if it receives FDA clearance. The company is also working with Deloitte Consulting to finalize its commercialization strategy and is continuing a search for a chief commercial officer. The company is preparing an outcome study intended to evaluate the benefits of DeepView across clinician workflows and the patient care journey. Capone said the study is expected to include approximately 240 patients across 12 clinical sites. → MP Materials Is Quietly Building a Rare Earth Powerhouse The study is designed to show how DeepView’s wound assessment can support surgical precision and improve the timing of treatment decisions, with the goal of demonstrating an impact on overall patient care and length of hospital stay. Spectral AI also plans to pursue international sales. Capone said that, following FDA clearance, the company expects to update its UKCA burn assessment approval, which it secured in 2024, to reflect the improved algorithm, hardware and software included in the FDA-submitted DeepView system. The company continues to expect initial sales in late 2026, pending expanded UKCA labeling, in the U.K., Australia or Gulf Cooperation Council countries. In March 2026, Spectral AI announced $31.7 million in advanced funding from the Biomedical Advanced Research and Development Authority, or BARDA. Capone said the award included a no-cost extension of the base phase of the company’s contract and the immediate acceleration of the second phase. The funding is expected to support additional feature design and aspects of the DeepView system, as well as the procurement of up to 30 devices for burn centers, Level 1 trauma centers and emergency departments. Asked about the expected cadence of the BARDA funding, Capone said some of the $31.7 million would be recognized in 2026, with most expected in 2027 and a smaller component potentially remaining in 2028. He said the revenue recognition timing is why the company does not expect to see much of the funding reflected in 2026 revenue. Spectral AI reiterated its 2026 revenue guidance of approximately $18.5 million, which includes the effect of the accelerated BARDA funding. Capone said the guidance does not include any significant contribution from DeepView system sales. Chief Financial Officer David McGuire, who recently joined Spectral AI, said R&D revenue for the first quarter of 2026 was $4.0 million, compared with $6.7 million in the prior-year period. He said the decline was expected and was primarily driven by completion of work under the base phase of the company’s Project BioShield contract with BARDA. That decline was partially offset by increased activity under other U.S. government contracts, including work on the company’s handheld device. Gross margin improved by 360 basis points to 50.8%, which McGuire attributed largely to a higher concentration of direct labor as a component of overall revenue. General and administrative expenses were $4.0 million, down slightly from $4.1 million a year earlier, reflecting cost discipline partially offset by higher public company infrastructure costs. Other expense was $1.5 million in the quarter, compared with other income of $3.9 million in the prior-year period. McGuire said the change was primarily driven by non-cash fair value adjustments related to the company’s warrant liability. Spectral AI reported a net loss of $3.4 million, or $0.11 per diluted share, compared with net income of $2.9 million, or $0.11 per diluted share, in the prior-year period. McGuire said that excluding the warrant fair value adjustments in both periods, underlying operating performance was generally in line with expectations. As of March 31, 2026, Spectral AI had $11.7 million in cash, compared with $15.4 million at Dec. 31, 2025. McGuire said cash usage reflected continued investment in R&D and commercialization initiatives. Total debt was $8.5 million, and the company had 31.8 million shares outstanding. Capone also provided an update on Spectral AI’s handheld device, which is being developed as part of a Department of Defense contract through the Medical Technology Enterprise Consortium, or MTEC. He said the company delivered a fully functioning prototype to MTEC last week, ahead of its previously stated expectation of delivery by the end of the second quarter. The company hopes to be asked to bid on Phase III of that contract later this year. Capone said Spectral AI would anticipate pursuing 510(k) approval of the handheld device using the cart-based DeepView system as its predicate. In response to an analyst question, Capone said Spectral AI does not expect to learn whether it will be selected to participate in Phase III until very late in 2026, with a decision time point believed to be December 2026. As a result, he said the company does not expect revenue from that phase in 2026, with potential revenue in 2027 and 2028 if selected. Capone said Spectral AI had a strong presence at the American Burn Association annual meeting in Orlando in April, where the DeepView system was featured in podium and poster presentations. He said Dr. Christopher Lewis presented an overview of the technology, including real-world experience and results, at the ABA Innovation Theater. During the Q&A, Capone said the meeting gave clinicians and other stakeholders an opportunity to see the device in person. He said the company was pleased with the “wait list” of potential installations that emerged from the conference. Spectral AI also discussed work on a Total Body Surface Area, or TBSA, tool included in its FDA-submitted device. Capone said the company is working on an advanced version internally referred to as “TBSA 2,” which he said should be available in 2027. He said further regulatory requirements for the upgraded tool should be “no more complicated” than a 510(k), and may not rise to that level, provided the TBSA component is approved as part of the De Novo application. Capone closed the call by thanking investors and reiterating management’s optimism about the company’s next phase as it seeks to move from development toward commercialization. Spectral AI, Inc (NASDAQ: MDAI) is a technology company focused on delivering advanced analytics and insights through the application of machine learning to multi-spectral and hyperspectral data. Its core platform ingests imagery from satellites, aerial drones and ground-based sensors, applying proprietary algorithms to identify patterns and anomalies invisible to the naked eye. The company's solutions are designed to help clients make more informed decisions in areas such as agriculture, environmental monitoring, infrastructure inspection and resource exploration. The company offers a cloud-native software-as-a-service (SaaS) platform that enables users to visualize and analyze large volumes of spectral data via customizable dashboards. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "Spectral AI Q1 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for May 2026.

This article first appeared on GuruFocus. Release Date: May 12, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Spectral AI Inc (NASDAQ:MDAI) has submitted a de novo application to the FDA and anticipates a response by the end of Q2 2026, which could lead to the commercialization of their DeepU system by the end of the year. The company secured $31.7 million in advanced funding from BARDA, which will support the development and procurement of up to 30 devices for burn centers and trauma centers. Spectral AI Inc (NASDAQ:MDAI) has expanded its leadership team, including the addition of a new CFO, and is working with Deloitte Consulting to finalize its commercialization strategy. The company successfully delivered a prototype of its handheld device to MTEC, which is part of a Department of Defense contract, and anticipates pursuing further phases of the contract. Spectral AI Inc (NASDAQ:MDAI) received the Small Business Innovator Award at the Texas Innovation Conference, highlighting its commitment to developing technology that improves patient outcomes for burn victims. R&D revenue for Q1 2026 decreased to $4 million from $6.7 million year-over-year, primarily due to the completion of work under the base phase of the company's Project BioShield contract with BARDA. The company reported a net loss of $3.4 million for Q1 2026, compared to a net income of $2.9 million in the prior-year period. Cash reserves decreased from $15.4 million at the end of 2025 to $11.7 million as of March 31, 2026, reflecting continued investment in R&D and commercialization initiatives. Spectral AI Inc (NASDAQ:MDAI) does not expect significant contributions from the sale of the DeepU system in its 2026 revenue guidance of $18.5 million. The company faces uncertainties related to FDA approval timelines and the potential impact on its commercialization plans. Warning! GuruFocus has detected 4 Warning Signs with MDAI. Is MDAI fairly valued? Test your thesis with our free DCF calculator. Q: Vince, can you expand on the FDA clearance timeline and the commercial activities in preparation for the DeepView launch? A: (Vincent Capone, CEO) We've had several pre-submission meetings with the FDA, and our submission was strong. We've maintained an active dialogue with the FDA and expect a resolution by the end of Q2. Commercially, we've been engaging with users in the UK and Australia, and we're preparing for expanded UKCA labeling to align with FDA approval, which will help us place devices in the UK and continue our work in Australia. Q: Can you provide insights into the $31.7 million BARDA contract funding and its impact on revenue? A: (Vincent Capone, CEO) The $31.7 million accelerated funding under Phase II will see some impact in 2026, but most revenue recognition will occur in 2027, especially with the launch of the economic outcome study. The funding will be spread across 2026, 2027, and a small component in 2028. Q: What feedback did you receive from stakeholders at the American Burn Association meeting? A: (Vincent Capone, CEO) The meeting was a great opportunity for stakeholders to interact with our device. We received positive feedback and a waitlist for potential installations. Dr. Chris Lewis's presentation highlighted the benefits of our technology in assessing burn wound severity, which was well-received. Q: If you win the handheld contract, will there be additional R&D revenues in 2026? A: (Vincent Capone, CEO) We don't expect to hear about Phase 3 participation until late 2026, so there will be no additional R&D revenues in 2026. If selected, most revenues would be recognized in 2027 and 2028. Q: How challenging is it to integrate the total body surface area (TBSA) module, and are there regulatory hurdles? A: (Vincent Capone, CEO) The TBSA tool is included in our FDA-submitted device, and we're working on an advanced version, TBSA2, expected in 2027. Regulatory hurdles should be minimal, possibly requiring a 510K, but it won't be more complicated than that. For the complete transcript of the earnings call, please refer to the full earnings call transcript.