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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(D) OF THE
SECURITIES EXCHANGE ACT OF 1934
Date of Report (Date of earliest event reported): March 17, 2025
SPECTRAL AI, INC.
(Exact name of registrant as specified in its charter)
| Delaware | 001-40058 | 85-3987148 | ||
| (State or other jurisdiction of incorporation) |
(Commission File Number) | (I.R.S. Employer Identification No.) |
|
2515 McKinney Avenue, Suite 1000 |
75201 | |
| (Address of principal executive offices) | (Zip Code) |
(972) 499-4934
(Registrant’s telephone number, including area code)
Not Applicable
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| ☐ | Written communication pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| ☐ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ☐ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ☐ | Pre-commencements communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbols | Name of each exchange on which registered | ||
| Common Stock, par value $0.0001 per share | MDAI | The Nasdaq Stock Market LLC | ||
| Redeemable Warrants, each whole warrant exercisable for one share of Common Stock, at an exercise price of $11.50 per share | MDAIW | The Nasdaq Stock Market LLC |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☒
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 7.01. Regulation FD Disclosure.
On March 17, 2025, the Company issued a press release announcing the results of the performance of its DeepView System in connection with the completion of its Burn Validation Study, a copy of which is furnished as Exhibit 99.1 to this Current Report on Form 8-K.
The information in this Item 7.01 to this Current Report on Form 8-K, and in Exhibit 99.1 furnished herewith, shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall such information be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
|
Exhibit |
Description | |
| 99.1 | Press Release issued by Spectral AI, Inc. on March 17, 2025 | |
| 104 | Cover Page Interactive Data File (formatted as Inline XBRL). |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Dated: March 17, 2025
| SPECTRAL AI, INC. | ||
| By: | /s/ Vincent S. Capone | |
| Name: | Vincent S. Capone | |
| Title: | Chief Financial Officer | |
2
Exhibit 99.1
Spectral AI Announces Successful Results from its Burn Validation Study of the DeepView System
● DeepView® System outperforms burn physicians in identifying non-healing tissue
● Landmark Burn Validation Study, one of the largest in U.S. history, confirms DeepView’s performance
● Spectral AI plans FDA submission by mid-2025, targeting De Novo Clearance and rapid commercialization to transform burn care
DALLAS, TX – 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.
The Burn Validation Study, which began in January 2024 and concluded in March 2025, represented one of the largest burn trials ever conducted in the United States. The Company enrolled and analyzed data obtained from 164 total patients comprised of 115 adult and 49 pediatric patients in burn centers and emergency departments across the U. S. in its Burn Validation Study. The goal of the Burn Validation Study was to further demonstrate the innovative and versatile nature of Spectral AI’s DeepView technology, as well as its ability to predict burn wound healing potential on the first day of injury with greater performance and speed than the methods currently used today. The Burn Validation Study results, together with rigorous statistical analysis, illustrate that the DeepView System continues to outperform the clinical judgment of burn physicians by a large margin.
The Burn Validation Study results assessed the sensitivity, specificity and Dice score of the DeepView System at both a pixel-level and image-wise level against the clinical judgment of burn physicians. Key findings included the following:
| ● | Sensitivity: The DeepView System demonstrated a statistically significant improvement in identifying non-healing tissue compared to burn physicians, as judged on sensitivity. At the image-wise level, the DeepView System scored 86.6% while clinical judgment annotation (CJA) of burn physicians scored 40.8%. At the pixel-wise level, the DeepView System scored 81.9% and CJA of burn physicians scored 38.8%. |
| ● | Dice Score: The DeepView System achieved statistically significant higher Dice Scores when compared to those derived from burn physicians’ CJA, representing the improved pixel-wise evaluation between predicated and true segmented wound areas with the DeepView System performing at 68.5% and burn physician’s CJA at 39.2%. |
| ● | Specificity: The Deepview System significantly outperformed the anticipated results for image-wise specificity in segmenting non-healing wound areas with a result of 61.2% (versus an anticipated result of 36.0%) and CJA of 79.1% reflecting burn physician’s conversative assessment of burn areas. |
2515 McKinney Ave., Suite #1000
Dallas, TX 75201
972-499-4934
www.spectral-ai.com
“We believe these are excellent results and we are thrilled with the analysis of our DeepView System in our Burn Validation Study,” said Dr J. Michael DiMaio, M.D. “The DeepView System exceeded our expectations in terms of predictive performance. Following the FDA’s review, if authorized by the agency, our hope is that this tool will provide an objective and immediate prediction of non-healing burn tissue to expedite patient care and reduce system costs across the board. I would like to thank Jeffrey C. Carter, MD, FACS, the principal investigator for the Burn Validation Study, our entire team at Spectral AI, and especially the patients and esteemed clinicians who participated in this Study. We look forward to bringing this predictive diagnostic tool to the United States marketplace as soon as possible.”
Spectral AI plans to submit these results to the FDA as part of its regulatory submission by the end of the second quarter of 2025 and hopes to have the FDA grant the De Novo Classification Request of the DeepView System in early 2026. Based on its current manufacturing arrangements, Spectral AI will be prepared to commercialize the DeepView System in the United States, if ultimately approved, as soon as approval is obtained.
This project is being supported in whole or in part with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response; BARDA, under contract number 75A50123C00049.
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 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. 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.
For Media and Investor Relations, please contact:
David Kugelman
Atlanta Capital Partners LLC
(866) 692-6847 Toll Free - U.S. & Canada
(404) 281-8556 Mobile and WhatsApp
Email: dk@atlcp.com
2515 McKinney Ave., Suite #1000
Dallas, TX 75201
972-499-4934
www.spectral-ai.com