Spectral AI Inc

Earnings data Q3 2023

Earnings data Q4 2023

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Earnings data Q3 2024

Earnings data Q4 2024

Spectral AI excels in Q2, eyes FDA approval and revenue growth

Spectral AI's strong Q2 performance, progress in AI technology, and strategic initiatives position them well for future growth. While facing challenges in FDA approval and commercialization, the company's cash position and revenue guidance offer stability and potential. Opportunities for growth through government contracts and capital access further enhance their prospects.

Spectral AI Inc reports robust Q3 results, eyes AI expansion

Spectral AI Inc (MDAI) demonstrated strong financial performance in Q3 2024, with revenue growth, improved margins, and a focus on key study milestones.
The company's strategic partnerships, clear priorities, and upcoming data release position it well for future growth and innovation in the medical AI space.
While facing challenges in regulatory compliance and market expansion, Spectral AI Inc has opportunities to diversify its offerings, enter new markets, and solidify its position as a leader in AI-based medical treatments.

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Spectral AI, Inc. is a predictive artificial intelligence company. It focuses on medical diagnostics for faster and more accurate treatment decisions in wound care for burn, DFU, and future clinical applications. Its DeepView platform is a predictive diagnostic device that offers clinicians an objective and immediate assessment of a wound's healing potential prior to treatment or other medical intervention. The company was founded on November 17, 2020 and is headquartered in Dallas, TX.

DALLAS, Dec. 23, 2024 (GLOBE NEWSWIRE) -- Spectral AI (NASDAQ: MDAI) (“Spectral AI” or the “Company”), developer of the AI-driven DeepView® System, which received Breakthrough Device Designation from the U.S. FDA in 2018, that uses multi-spectral imaging and algorithms to predict burn healing potential, is pleased to announce that on December 20, 2024 the Company received a “moot” letter from Nasdaq confirming that the Company has regained compliance with all applicable listing standards for its continued listing on the Nasdaq Capital Market and that a further hearing regarding the Company's compliance is no longer necessary.

Spectral AI Announces Confirmation of Compliance of its Nasdaq Listing Requirements

DALLAS, Dec. 13, 2024 (GLOBE NEWSWIRE) -- Spectral AI (NASDAQ: MDAI) (“Spectral AI” or the “Company”), developer of the AI-driven DeepView® System, which received Breakthrough Device Designation from the U.S. FDA in 2018, that uses multi-spectral imaging and algorithms to predict burn healing potential, today announced today that the Company believes it has regained compliance with Nasdaq Listing Rule 5550(b)(2), which requires listed companies to maintain a minimum market value of listed securities of $35 million.

Spectral AI Comments on Compliance with Nasdaq Listing Rule 5550(b)(2)

DALLAS, Dec. 09, 2024 (GLOBE NEWSWIRE) -- Spectral AI (NASDAQ: MDAI) (“Spectral AI” or the “Company”), an artificial intelligence (AI) company focused on revolutionizing medical diagnostics to enable faster, more accurate treatment decisions in wound care, today announced the completion of enhancements to its technical file to support significant software updates for its DeepView SnapShot® M and DeepView AI-Burn® system in the UK. These upgrades, informed by real-world experience and frontline feedback from clinicians, are designed to enhance product performance and usability in the UK, further solidifying the Company's commitment to delivering and commercializing cutting-edge solutions in critical care settings.

Spectral AI Incorporates Frontline Feedback into Improved Software Release for Enhanced Diagnostic Precision

DALLAS, Dec. 02, 2024 (GLOBE NEWSWIRE) -- Spectral AI (NASDAQ: MDAI) (“Spectral AI” or the “Company”), an artificial intelligence (AI) company focused on revolutionizing medical diagnostics to enable faster, more accurate treatment decisions in wound care, today announced the successful completion of truthing for all images gathered from burn centers across the United States. This milestone represents a pivotal step in training the Company's proprietary DeepView® System to predict wound healing outcomes accurately. Having completed the process for burn centers, Spectral AI is now initiating truthing for images collected from emergency departments and emergency rooms nationwide, expanding the scope of the DeepView® System's capabilities.

Spectral AI Completes Truthing of Burn Center Images, Initiates Emergency Department Image Review

DALLAS, Nov. 26, 2024 (GLOBE NEWSWIRE) -- Spectral AI (NASDAQ: MDAI) (“Spectral AI” or the “Company”), an artificial intelligence (AI) company focused on revolutionizing medical diagnostics to enable faster, more accurate treatment decisions in wound care, today announced the repricing of its 8,433,333 publicly-traded common share purchase warrants with an exercise price of $11.50 per share to $2.75 per share, effective following its twenty day notice requirement. The warrants currently trade on NASDAQ under the symbol MDAIW.

Spectral AI Announces Repricing of its Public Warrants

DALLAS, Nov. 19, 2024 (GLOBE NEWSWIRE) -- Spectral AI, Inc. (Nasdaq: MDAI) (“Spectral AI” or the “Company”), an artificial intelligence (AI) company focused on revolutionizing medical diagnostics to enable faster, more accurate treatment decisions in wound care, today announced the successful completion of an approximate $5.0 million equity financing in an at-the-market transaction. The closing is to be completed in two tranches. Part of the proceeds will be used for the retirement of its outstanding obligations with Yorkville Advisors. This transaction supports Spectral AI's growth trajectory and progress toward a submission to the U.S. Food and Drug Administration (“FDA”) for approval of its DeepView AI®-Burn system, a crucial milestone targeted for the first half of 2025.

Spectral AI Raises Up to $5 Million Financing Strengthening Financial Position for FDA Pathway

Spectral AI, Inc. (NASDAQ:MDAI ) Q3 2024 Earnings Conference Call November 6, 2024 5:00 PM ET Company Participants Devin Sullivan - MD of Equity Group Michael DiMaio - Chairman Vincent Capone - CFO Conference Call Participants Ryan Zimmerman - BTIG Carl Byrnes - Northland Capital Markets RK Ramakanth - H.C. Wainwright John Vandermosten - Zacks Operator Good afternoon, and welcome to the Spectral AI Third Quarter 2024 Financial Results Conference Call.

Spectral AI, Inc. (MDAI) Q3 2024 Earnings Conference Call Transcript

Spectral AI Inc (NASDAQ:MDAI) reported a strong financial performance for the third quarter of 2024, highlighted by a 138% increase in research and development revenue as it advanced its burn wound technology. For Q3 2024, the company posted $8.2 million in revenue, up from $3.4 million in the same quarter last year.

Spectral AI reports strong Q3 performance, reaffirms FDA submission timeline

Revenue Rose to $8.2 Million Company Reaffirms Timeline for Regulatory Submission to U.S. FDA

Spectral AI Announces 2024 Third Quarter Financial Results

Spectral AI Inc (NASDAQ:MDAI) announced plans to spin off its subsidiary, Spectral IP, Inc., through a deal with Sauvegarder Investment Management, Inc. (SIM). The transaction aims to position Spectral IP as an independent company with a broader focus on intellectual property (IP) monetization across various sectors, including healthcare, artificial intelligence, and semiconductors.

Spectral AI to spin off subsidiary to focus on IP monetization, healthcare AI expansion

Strategic Spinoff Aims to Unlock IP Value and Sharpen Focus on AI Medical Diagnostics Strategic Spinoff Aims to Unlock IP Value and Sharpen Focus on AI Medical Diagnostics

Spectral AI Announces Plan to Spin Off Spectral IP Subsidiary Focused on Intellectual Property Investments and Monetization

Spectral AI Inc (NASDAQ:MDAI) announced that the final group of patients at burn centers in its US Burn Pivotal Study have completed their clinical visits, with topline results expected in December 2024. This study is expected to be the final clinical trial before Spectral AI seeks Food and Drug Administration (FDA) approval for its DeepView System, a medical device that can assess burn wounds non-invasively.

Spectral AI moves closer to FDA filing for burn wound assessment device

DALLAS, Oct. 23, 2024 (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 third quarter ended September 30, 2024 on Wednesday, November 6, 2024 after the close of the stock market. The Company will host a corresponding conference call at 5:00 pm Eastern Time that day to discuss the results.

Spectral AI Schedules 2024 Third Quarter Financial Results and Conference Call

Dublin, Oct. 23, 2024 (GLOBE NEWSWIRE) -- The "AI in Wound Care Market Industry Trends and Global Forecasts to 2035: Distribution by Type of Wound, Type of Acute Wound, Type of Chronic Wound, Type of AI Technology, End User and Key Geographical Regions" report has been added to ResearchAndMarkets.com's offering.

AI in Wound Care Market Industry Research Report 2024-2035 Featuring Key Players - eKare, healthy.io, Kronikare, Intellicure, Perceptive Solutions, Spectral AI, Swift Medical, Wound Pros Among Others

Spectral AI Inc (NASDAQ:MDAI) announced that its founder Dr J Michael DiMaio has been appointed chairman of the board of directors. DiMaio, a seasoned cardiothoracic surgeon and former CEO of the company, is expected to lead Spectral AI through its next phase of growth, focusing on the commercialization and FDA approval of its DeepView System for wound care.

Spectral AI founder returns as board chairman

DALLAS, Oct. 14, 2024 (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 the Company's Founder, Dr. J. Michael DiMaio, has been named Chairman of the Board of Directors.

Spectral AI, Inc. Announces Return of Founder Dr. J. Michael DiMaio as Chairman of the Board of Directors

Spectral AI Inc (NASDAQ:MDAI) announced the completion of a proof-of-concept module of its wound measurement technology that calculates the total body surface area of a burn wound. The company said that this technology, now integrated into the company's DeepView System for burn care, offers fast, accurate, and standardized burn size measurements.

Spectral AI completes proof-of-concept for wound measurement technology

Provides Clinicians with Superior Wound Size Measurement Information that Improves Patient Treatment Decisions Provides Clinicians with Superior Wound Size Measurement Information that Improves Patient Treatment Decisions

Spectral AI Completes Proof of Concept for Wound Measurement Technology

Spectral AI Inc (NASDAQ:MDAI) announced a significant milestone in its U.S. Burn Pivotal Study with 25% of patient enrollment completed in Emergency Departments (EDs).

Spectral AI reaches key milestone in US burn study, expands clinical trial sites

DALLAS, Sept. 24, 2024 (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 has achieved 25% patient enrollment at Emergency Departments (“ED”) for its U.S. Burn Pivotal Study and added two new ED Clinical Trial Sites for this study: MedStar Washington Hospital Center in Washington, DC led by Principal Investigator Shawn Tejiram, MD and the University of Utah led by Principal Investigator Giavonni Lewis, MD, FACS. The addition of these two clinical research sites expands participating EDs to 11 facilities.

Spectral AI Achieves 25% Patient Enrollment at Emergency Departments for U.S. Burn Pivotal Study and Adds Two New Clinical Trial Sites

Spectral AI Inc (NASDAQ:MDAI) has outlined its US regulatory strategy for its DeepView AI burn system, a device designed to assess burn healing potential using multi-sepctral imaging and AI. The device, which received FDA Breakthrough Device Designation in 2018, provides rapid predictions on wound healing, assisting clinicians in treatment decisions.

Spectral AI preparing to seek FDA approval of DeepView burn assessment device

DALLAS, Sept. 17, 2024 (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 provided an outline of its regulatory pathway strategy to enter the U.S. market with its flagship DeepView® System for burn indication (“DeepView AI®-Burn”).

Spectral AI Outlines U.S. Regulatory Pathway for DeepView® System for Burn Indication

Spectral AI Inc (NASDAQ:MDAI) has highlighted how its DeepView System has been designed to broaden equity in burn care access and optimize healthcare resources following the release of a new report from the American Burn Association (ABA) which noted physical and economic barriers to burn care specialists. The report, published in the Journal of Burn Care & Research January/February 2024, spotlighted the uneven distribution of ABA-verified burn centers across the United States, particularly impacting rural and pediatric patients.

Spectral AI highlights potential of its wound analysis device to bridge burn care gaps

Spectral AI's DeepView® System Designed to Provide Equity in Burn Care Access While Optimizing Healthcare Resources Spectral AI's DeepView® System Designed to Provide Equity in Burn Care Access While Optimizing Healthcare Resources

American Burn Association Study Highlights Inequities in Access to Specialized Burn Care

Spectral AI Inc (NASDAQ:MDAI) announced that it has been awarded more than $850,000 from the Medical Technology Enterprise Consortium (MTEC), a biomedical group collaborating with the US Army Medical Material Development Activity, to support the ongoing development of its DeepView SnapShot M. Spectral AI's DeepView SnapShot M is a handheld predictive wound healing device targeting battlefield applications based on its AI-driven DeepView System Platform, which uses multispectral imaging trained against a database of more than 340 billion clinically validated data points to assess a burn wound's healing potential before other medical intervention.

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