| Spectral AI, Inc. (MDAI) Q1 2025 Earnings Call Transcript |
Spectral AI, Inc. (NASDAQ:MDAI ) Q1 2025 Earnings Conference Call May 13, 2025 5:00 PM ET Company Participants Sara Prendergast - Assistant General Counsel Vincent Capone - CFO Conference Call Participants Ryan Zimmerman - BTIG Carl Byrnes - Northland Capital Markets John Vandermosten - Zacks Vadim Khalil - SP Angel Operator Good day, and welcome to the Spectral AI, Inc. First Quarter 2025 Financial Results Conference Call. [Operator Instructions] Please note that this event is being recorded. |
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2025-05-14 01:40:32 |
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| Spectral AI Announces 2025 First Quarter Financial Results |
Q1 Overview Research & Development Revenue of $6.7 Million Improved Capital Structure Reflected in Cash of $14.1 Million Continued work on planned De Novo submission to the FDA in the first half of 2025 DALLAS, May 13, 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 financial results for the first quarter ended March 31, 2025 and provided an update on its ongoing business activities. “During the first quarter we continued to execute against our strategic plan and are working hard towards our De Novo submission to the FDA by the end of the first half of 2025,” said Dr. J. |
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2025-05-13 20:05:00 |
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| Burn clinicians present positive findings of the DeepView® System's accuracy at the American Burn Association annual meeting |
DALLAS, April 30, 2025 (GLOBE NEWSWIRE) -- Spectral AI, Inc. (NASDAQ: MDAI) (“Spectral AI” or the “Company”), a leading developer of the AI-driven DeepView® System, which uses multi-spectral imaging and AI algorithms to predict burn healing potential today announced its successful participation at the American Burn Association annual meeting, dedicated to burn awareness and prevention. The event, held from April 7th - 11th in Phoenix, Arizona, brought together over 2,200 burn care professionals worldwide. |
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2025-04-30 20:00:00 |
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| Spectral AI, Inc. (MDAI) Q4 2024 Earnings Call Transcript |
Spectral AI, Inc. (NASDAQ:MDAI ) Q4 2024 Earnings Conference Call March 27, 2025 5:00 PM ET Company Participants Sara Prendergast - Assistant General Counsel Michael DiMaio - Chairman Vincent Capone - CFO Jihang Wang - Director of Data Science at Spectral AI Conference Call Participants Carl Byrnes - Northland Capital Markets Ryan Zimmerman - BTIG John Vandermosten - Zacks RK Ramakanth - H.C. Wainwright Operator Good afternoon, and welcome to the Spectral AI Fourth Quarter and Full Year 2024 Financial Results Conference Call. |
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2025-03-27 21:06:38 |
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| Spectral AI Announces 2024 Fourth Quarter and Full Year Financial Results |
2024 Research & Development Revenue of $30 Million |
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2025-03-27 18:55:00 |
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| Spectral AI Raises up to $15 Million of Debt Financing and Strengthens Financial Position for U.S. Commercialization |
DALLAS, March 24, 2025 (GLOBE NEWSWIRE) -- Spectral AI, Inc. (NASDAQ: MDAI) ("Spectral AI" or the "Company"), a leading developer of the AI-driven DeepView® System, which uses multi-spectral imaging and AI algorithms to predict burn healing potential, today announced the successful completion of a debt financing agreement of up to $15.0 million in funding from Avenue Venture Opportunities Fund II, L.P., a fund of Avenue Capital Group, with an initial draw down of $8.5 million. In connection with this debt financing, the Company also raised $2.7 million of equity financing from institutional as well as existing investors. With total cash on hand now of over $14 million and potential access to additional debt of $6.5 million, Spectral AI is able to accelerate its product commercialization efforts, including the upcoming U.S. launch of its DeepView System. |
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2025-03-24 09:30:00 |
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| Spectral AI Announces Public Filing of Registration Statement for Proposed Initial Public Offering of Spectral IP |
DALLAS, March 20, 2025 (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. Food and Drug Administration in 2018 and uses multi-spectral imaging and AI algorithms to predict burn healing potential, today announced that its wholly-owned subsidiary, Spectral IP, Inc., has publicly filed a registration statement with the U.S. Securities and Exchange Commission (“SEC”) relating to its planned spinoff through an initial public offering of its shares of common stock. Spectral IP, Inc. will be renamed SIM IP Inc. (“SIM IP”) prior to the completion of this offering. |
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2025-03-20 18:00:00 |
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| Spectral AI Announces Successful Results from its Burn Validation Study of the DeepView System |
DALLAS, March 17, 2025 (GLOBE NEWSWIRE) -- Spectral AI (NASDAQ: MDAI) (“Spectral AI” or the “Company”), developer of the AI-driven DeepView® System, that uses multi-spectral imaging and AI algorithms to predict burn healing potential, announced the successful results of the performance of its DeepView System in connection with the completion of its Burn Validation Study. Spectral AI's DeepView System is being developed as a predictive device to offer clinicians an immediate and objective assessment of a burn wound's healing potential prior to treatment or other medical intervention. The image processing algorithm employed by the DeepView System utilizes multispectral imaging that is trained and tested against a proprietary database of more than 340 billion clinically validated data points. The DeepView System is non-invasive and cart-based, allowing for exceptional mobility within the healthcare setting. |
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2025-03-17 09:00:00 |
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| Spectral AI Completes Three Device Installations in Australia |
DALLAS, March 06, 2025 (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. Food and Drug Administration (“FDA”) in 2018 and uses multi-spectral imaging and AI algorithms to predict burn healing potential, today announced the completion of the installation of three of the DeepView System devices in Australia. The Company, in partnership with global medical device company and burn wound therapy leader PolyNovo Limited (“PolyNovo”). The Company was able to utilize the Australian Special Access Scheme (SAS) to deploy three DeepView Systems at the Concord Repatriation General Hospital in Sydney, the Royal Adelaide Hospital in Adelaide and the Fiona Stanley Hospital in Murdoch (Perth). The installation of these devices will support the Company's eventual commercial roll-out based on clinician evaluations and experiences using the device. |
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2025-03-06 12:36:00 |
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| CORRECTION: Spectral AI Schedules 2024 Fourth Quarter and Full Year Financial Results and Conference Call |
DALLAS, Feb. 28, 2025 (GLOBE NEWSWIRE) -- In a release issued under the same headline earlier today by Spectral AI, Inc. (NASDAQ: MDAI), the reporting date of the financial results for the fourth quarter was incorrectly stated, and has been amended. The corrected release follows: |
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2025-02-28 12:34:00 |
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| Spectral AI Completes Data Analysis for U.S. Burn Pivotal Study |
DALLAS, Feb. 07, 2025 (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. Food and Drug Administration (“FDA”) in 2018 and uses multi-spectral imaging and AI algorithms to predict burn healing potential, today announced the completion of its data analytics for its U.S. Burn Pivotal Study. One of the largest domestic burn studies ever conducted, the U.S. Burn Pivotal Study is designed to validate the AI-driven algorithm used by the Company's DeepView® System for its burn indication. Spectral AI's DeepView® System is a predictive medical device and associated software that assesses the healing potential of burn wounds by combining multispectral imaging with an AI-driven algorithm trained and tested against a proprietary database of more than 340 billion clinically-validated data points. By distinguishing between healing and non-healing tissue, the DeepView® System provides an immediate and binary prediction of wound healing on the same day of injury, benefiting clinical decision-making regarding next step treatment. |
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2025-02-07 10:21:00 |
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| Spectral AI Completes Pediatric Enrollment in Emergency Departments for U.S. Burn Pivotal Study |
DALLAS, Jan. 28, 2025 (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 the completion of its pediatric enrollment at U.S. emergency departments for its U.S. Burn Pivotal Study. One of the largest domestic burn studies ever conducted, the U.S. Burn Pivotal Study is designed to validate the AI-driven algorithm used by the Company's DeepView™ System for burn indication. |
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2025-01-28 11:44:00 |
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| Spectral AI Provides Update to Investors |
DALLAS, Jan. 22, 2025 (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 an update on its operating results. |
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2025-01-22 10:00:00 |
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| Spectral AI Provides Instructions for Retail Investors on Exercising Publicly-Traded Warrants |
DALLAS, Dec. 31, 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 instructions for retail investors on how to exercise any publicly-traded warrants (NASDAQ: MDAIW). The warrant exercise process includes the following steps: |
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2024-12-31 10:00:00 |
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| Spectral AI Announces Confirmation of Compliance of its Nasdaq Listing Requirements |
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. |
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2024-12-23 10:00:00 |
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| Spectral AI Comments on Compliance with Nasdaq Listing Rule 5550(b)(2) |
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. |
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2024-12-13 13:53:00 |
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| Spectral AI Incorporates Frontline Feedback into Improved Software Release for Enhanced Diagnostic Precision |
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. |
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2024-12-09 10:00:00 |
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| Spectral AI Completes Truthing of Burn Center Images, Initiates Emergency Department Image Review |
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. |
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2024-12-02 10:39:00 |
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| Spectral AI Announces Repricing of its Public Warrants |
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. |
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2024-11-26 12:17:00 |
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| Spectral AI Raises Up to $5 Million Financing Strengthening Financial Position for FDA Pathway |
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. |
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2024-11-19 10:00:00 |
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| Spectral AI, Inc. (MDAI) Q3 2024 Earnings Conference Call Transcript |
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. |
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2024-11-09 16:09:50 |
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| Spectral AI reports strong Q3 performance, reaffirms FDA submission timeline |
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. |
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2024-11-06 18:27:08 |
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| Spectral AI Announces 2024 Third Quarter Financial Results |
Revenue Rose to $8.2 Million Company Reaffirms Timeline for Regulatory Submission to U.S. FDA |
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2024-11-06 18:05:00 |
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| Spectral AI to spin off subsidiary to focus on IP monetization, healthcare AI expansion |
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. |
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2024-11-06 10:56:22 |
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| Spectral AI Announces Plan to Spin Off Spectral IP Subsidiary Focused on Intellectual Property Investments and Monetization |
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 |
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2024-11-06 10:00:00 |
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| Spectral AI moves closer to FDA filing for burn wound assessment device |
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. |
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2024-10-30 10:44:30 |
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| Spectral AI Schedules 2024 Third Quarter Financial Results and Conference Call |
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. |
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2024-10-23 20:50:00 |
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| 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 |
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. |
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2024-10-23 08:01:00 |
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| Spectral AI founder returns as board chairman |
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. |
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2024-10-15 12:51:29 |
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| Spectral AI, Inc. Announces Return of Founder Dr. J. Michael DiMaio as Chairman of the Board of Directors |
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. |
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2024-10-14 20:05:00 |
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| Spectral AI completes proof-of-concept for wound measurement technology |
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. |
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2024-10-03 13:38:07 |
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| 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 |
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2024-10-03 12:00:00 |
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| Spectral AI reaches key milestone in US burn study, expands clinical trial sites |
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). |
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2024-09-24 13:25:09 |
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