DALLAS, June 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 annual British Burn Association (BBA) conference, held from June 4 – 6 in Brighton, UK. The Company was featured in multiple presentations, highlighting its contributions to advancing burn care across the globe. Key Presentati ...

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]

Core Viewpoint - Spectral AI, Inc. held its 2025 Annual Meeting of Stockholders, where stockholders approved both proposals presented by the Company, with 15,551,068 shares, representing 60.8% of total shares outstanding, participating in the meeting [1][2]. Group 1: Company Overview - Spectral AI is a Dallas-based predictive AI company focused on 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 results that exceed the current standard of care [3]. Group 2: Governance and Financial Oversight - Six directors were elected to the Company's Board of Directors to serve until the next Annual Meeting of Stockholders [2]. - Stockholders ratified the appointment of KPMG LLP as the independent registered public accounting firm for the 2025 fiscal year [2].

Core Insights - Spectral AI's DeepView System has demonstrated a 95.3% overall accuracy in predicting burn healing potential, significantly outperforming traditional subjective assessments [1][2] - The technology has been recognized in the journal Burns, highlighting its clinical importance and transformative role in burn care [2] Company Overview - Spectral AI, Inc. is a Dallas-based predictive AI company focused on enhancing medical diagnostics for wound care, particularly for burn patients [3] - The DeepView System aims to provide objective and immediate assessments of burn wounds, facilitating faster and more accurate treatment decisions [3] - The company is committed to improving patient outcomes and reducing healthcare costs through its innovative technology [3] Clinical Significance - The study published in Burns represents the first multi-center evaluation of AI-enhanced multispectral imaging in burn assessment, showcasing the effectiveness of the DeepView System across various clinical settings [2] - The technology empowers clinicians with data-driven insights, improving decision-making regarding healing time and the need for surgical interventions [2] Industry Context - Burns is a prominent peer-reviewed medical journal dedicated to advancements in burn care and wound healing, serving as a critical platform for sharing innovative techniques and best practices [2]

Core Insights - Spectral AI, Inc. announced that its research partners have won the Best Research Project award at the 2025 Education Awards for their work on diabetic foot ulcers using the DeepView System [1][3] Company Overview - Spectral AI is a Dallas-based predictive AI company focused on medical diagnostics, particularly in wound care, with initial applications for burn patients [4] - The DeepView System utilizes multi-spectral imaging and AI algorithms to provide objective assessments of burn wound healing potential [4] Research and Development - The awarded project demonstrates the integration of real-time multispectral imaging with AI analytics to enhance evaluation and treatment strategies for diabetic foot ulcers [3] - The research validates the clinical value of the DeepView System and contributes to expanding its clinical evidence base [3] Market Positioning - The findings from the research are expected to shape the company's commercialization strategy and position it strongly for broader market entry [3]

Financial Performance - The company generated research and development revenue of $6,707,000 for the three months ended March 31, 2025, representing a 6.0% increase from $6,326,000 in the same period of 2024[115]. - Gross profit for the same period was $3,168,000, with a gross margin of 47.2%, compared to a gross profit of $2,945,000 and a gross margin of 46.6% in 2024[101]. - The company reported a net income of $2,897,000 for the three months ended March 31, 2025, a significant improvement from a net loss of $3,205,000 in the prior year[114]. - Operating loss for the three months ended March 31, 2025, was $896,000, a reduction from an operating loss of $2,143,000 in the same period of 2024[114]. - Adjusted EBITDA for the three months ended March 31, 2025, was $(694) thousand, improving from $(1,857) thousand in the comparable period in 2024[126]. - General and administrative expenses decreased by 20.1% to $4.1 million for the three months ended March 31, 2025, down from $5.1 million in 2024[119]. - Net cash used in operating activities decreased by approximately $1.2 million to $(1.5) million for the three months ended March 31, 2025[136]. - Net cash provided by financing activities increased to approximately $10.3 million for the three months ended March 31, 2025, compared to $8.0 million in 2024[137]. Contracts and Funding - The company has received a new contract with BARDA, providing up to $150 million in funding, including an initial award of approximately $54.9 million for clinical validation of the DeepView System[95]. - The total potential support from BARDA is nearly $272.9 million, including the new PBS BARDA Contract valued at $54.9 million[128]. - The company has received a $4.9 million grant from MTEC, intended to support military battlefield burn evaluation via a handheld DeepView System device[96]. Clinical Studies and Product Development - The company completed enrollment of a pivotal clinical study with 267 patients, including 42 pediatric patients, across 22 sites in the United States[93]. - The company anticipates two revenue streams from the DeepView System: a software as a medical device (SaMD) model and an imaging device component[97]. - The company has not generated any product revenue to date, relying on contract development and research services for revenue[94]. Shareholder and Financing Activities - The company began trading its shares on the Nasdaq under the symbols "MDAI" and "MDAIW" following the completion of a Business Combination on September 12, 2023[99]. - The company entered into a Loan and Security Agreement allowing it to borrow up to $15.0 million, with an initial drawdown of $8.5 million[129]. - Avenue Financing includes warrant coverage equal to 8.5% of the total funding commitment, with an exercise price of $1.66[140]. - Spectral IP received a $1.0 million investment from an affiliate of its largest stockholder for developing artificial intelligence intellectual property[141]. - The Spectral IP Note was amended to reduce the annual interest rate from 8% to 4% and extend the term through March 18, 2026[142]. - The holder of the Spectral IP Note converted it into 540,996 shares of Common Stock at a 5% discount to the closing price[142]. Cash Position and Risks - As of March 31, 2025, the company had approximately $14.1 million in cash and an accumulated deficit of approximately $45.3 million[127]. - The company maintains a significant amount of cash, with interest rates on current borrowings at Prime plus 5.25%[152]. - The company has not recognized any losses from credit risks on cash, indicating a low exposure to significant credit risk[154]. - Inflationary pressures may adversely affect the company's gross margin and cash flows if costs continue to rise significantly[156]. Company Classification - The company is classified as an emerging growth company, allowing it to delay the adoption of certain accounting standards[147]. - One customer, a U.S. government agency, represents the majority of the company's research and development revenue and accounts receivable[155]. - The company has no off-balance sheet arrangements during the periods presented[143].

Spectral AI (MDAI) Q1 2025 Earnings Call May 13, 2025 05:00 PM ET Company Participants Sara Prendergast - Assistant General CounselVince Capone - CFO & General Counsel Conference Call Participants Ryan Zimmerman - Managing Director & Medical Technology AnalystCarl Byrnes - Managing Director, Senior Research AnalystJohn Vandermosten - Senior AnalystVadim Alexandre Khalil - Healthcare Analyst Operator Please note that this event is being recorded. I would now like to turn the conference over to Sarah Prenderg ...

Financial Data and Key Metrics Changes - Research and development revenue for Q1 2025 rose 6% to $6,700,000 from $6,300,000 in Q1 2024, reflecting increased activity under the BARDA Project BioShield contract [12] - Gross margin increased to 47.2% from 46.6% in Q1 2024 due to a higher concentration of direct labor as a component of revenue [12] - General and administrative expenses decreased significantly from $5,100,000 in Q1 2024 to $4,100,000 in Q1 2025, primarily due to a focus on the BARDA contract and cost-cutting measures [12] - Operating loss for Q1 2025 was $896,000 compared to a net loss of $2,100,000 in Q1 2024 [13] - The company reported net income of $2,900,000 in Q1 2025, a significant improvement from a net loss of $3,200,000 in the same quarter last year [13] - Cash and cash equivalents totaled $14,100,000 as of March 31, 2025, up from $5,200,000 on December 31, 2024 [14] Business Line Data and Key Metrics Changes - The company is focused on advancing its DeepView technology and preparing for FDA submission, which is a key milestone for its product line [5][6] - The DeepView Snapshot M handheld device is in development, with two prototypes successfully assembled [9] Market Data and Key Metrics Changes - The company reiterated its revenue guidance for 2025 at approximately $21,500,000, which does not include contributions from sales of the DeepView system in the UK or Australia [14] Company Strategy and Development Direction - The company is transitioning from a research-focused organization to a commercial entity with a well-defined business focus for 2025 and beyond [4] - The primary goal is to achieve FDA de novo classification submission by the end of Q2 2025, which is critical for future growth [5] - The company is also developing its healthcare intellectual property subsidiary, Spectral IP, which is in the SEC registration process for an initial public offering [10] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the revenue guidance and noted that the first quarter's strong performance reflects efforts to focus on the FDA submission [18][19] - The company has had over 10 pre-submission meetings with the FDA, which have been constructive and supportive [22][23] - Management is optimistic about the prospects for growth and development, emphasizing the importance of the BARDA partnership [40][41] Other Important Information - The company completed a debt financing agreement of up to $15,000,000, with an initial drawdown of $8,500,000, and raised approximately $2,700,000 in equity financing [7][8] - The burn validation study results, which utilized over 340 billion clinically validated data points, demonstrated the effectiveness of the DeepView technology [6] Q&A Session Summary Question: Guidance on revenue expectations - Management indicated that the revenue guidance of $21,500,000 seems reasonable, although they may restate it if performance continues to exceed expectations [18][19] Question: Preparation for FDA submission - Management highlighted a strong relationship with BARDA and noted that they have been working closely with the FDA to de-risk the submission process [22][23] Question: General administrative expenses outlook - Management anticipates general and administrative expenses to remain consistent with Q1 results, focusing on operational efficiencies [32][33] Question: Development of Snapshot M device - Management confirmed that while they are focused on the FDA submission, they are also advancing the development of the Snapshot M device for military use [38][41] Question: Future relationships with the DoD - Management acknowledged the importance of developing relationships with the DoD and emphasized ongoing efforts to improve the Snapshot M device [49][50]

Core Insights - Spectral AI, Inc. reported financial results for Q1 2025, highlighting progress in its strategic plan and ongoing efforts towards FDA De Novo submission by mid-2025 [1][2] - The company completed a significant Burn Validation Study, demonstrating the effectiveness of its DeepView™ System in predicting burn wound healing potential [2][3] Financial Performance - Research & Development Revenue increased by 6.0% to $6.7 million in Q1 2025 from $6.3 million in Q1 2024, driven by heightened activity under the BARDA contract [5] - Gross margin improved to 47.2% in Q1 2025 from 46.6% in Q1 2024, attributed to a higher concentration of direct labor reimbursement under the BARDA contract [6] - General & Administrative expenses decreased to $4.1 million in Q1 2025 from $5.1 million in Q1 2024, reflecting a focused effort on the BARDA contract [10] - The company reported a net income of $2.9 million in Q1 2025, a significant turnaround from a net loss of $(3.2) million in Q1 2024, primarily due to changes in the fair value of warrant liabilities [12] Capital Structure and Financing - Cash reserves improved to $14.1 million as of March 31, 2025, up from $5.2 million at the end of 2024 [13] - The company secured a debt financing agreement of up to $15.0 million, with an initial drawdown of $8.5 million in March 2025, alongside raising $2.7 million in equity financing [9][13] - The company satisfied all obligations related to its SEPA in February 2025 [14] Business Highlights - The Burn Validation Study, one of the largest burn trials in the U.S., involved 164 patients, including 115 adults and 49 pediatric patients [3] - The DeepView™ System aims to revolutionize wound care management by providing objective assessments of burn wounds, potentially improving patient outcomes and reducing healthcare costs [17] Guidance - The company reiterated its revenue guidance of approximately $21.5 million for FY 2025, excluding contributions from the DeepView™ System sales [15]

Core Viewpoint - Spectral AI, Inc. is set to report its financial results for Q1 2025 on May 13, 2025, and will host a conference call to discuss these results [1] Company Overview - Spectral AI, Inc. is a Dallas-based predictive AI company focused on medical diagnostics, particularly in wound care, with initial applications for burn patients [3] - The company is developing the DeepView System, which utilizes multi-spectral imaging and AI algorithms to predict burn healing potential, aiming to provide clinicians with objective assessments prior to treatment [3] - The DeepView System is designed to improve patient outcomes and reduce healthcare costs by offering fast and accurate treatment insights, with the goal of exceeding current standards of care [3]