Spectral AI Advances Burn Study with Expanded Clinical Trial Sites and Increased Patient Enrollment

Spectral AI expands burn study with new clinical trial sites By Investing.com

DALLAS - Spectral AI, Inc. (NASDAQ:MDAI), a company specializing in artificial intelligence for medical diagnostics, has announced the inclusion of two new Emergency Department (ED) clinical trial sites in its U.S. Burn Pivotal Study. The study, which has now enrolled 25% of its patient target, includes MedStar Washington Hospital Center and the University of Utah, bringing the total number of participating EDs to 11. The U.S. Burn Pivotal Study is one of the largest domestic burn studies to date, aiming to validate the AI-driven algorithm of the company's DeepView® System for burn indication (DeepView AI®-Burn). Spectral AI's CEO, Peter M. Carlson, highlighted the growing need for advanced burn treatment support in EDs due to the decline in specialized burn treatment access in the U.S. The DeepView® System is designed to differentiate between healing and non-healing tissue, providing an immediate prediction of wound healing that could assist in clinical decisions from the first day. This system is expected to offer burn expert-level clinical support to ED clinicians, who often face the initial responsibility of assessing burn wounds. Previously, Spectral AI completed enrollment for both adult and pediatric patients at U.S. burn centers for this pivotal study. The company plans to use the data gathered from these burn center patients to seek FDA classification of DeepView AI®-Burn as a Class II medical device through a De Novo submission, expected in the second quarter of 2025. Spectral AI is focused on revolutionizing wound care management by providing clinicians with objective assessments of a wound's healing potential, which could lead to improved patient outcomes and reduced healthcare costs. This news is based on a press release statement from Spectral AI, Inc. and does not endorse any claims or promote the company. It is intended to provide a factual report on the company's study expansion and its potential implications for the medical diagnostics field. In other recent news, Spectral AI has made significant strides in its operations. The company has completed patient enrollment for its U.S. Burn Pivotal Study, aiming to introduce its DeepView® System, a burn assessment tool, to the U.S. market. Spectral AI intends to submit a De Novo request to the FDA in the second quarter of 2025 for classification of the device. Additionally, Spectral AI has secured over $850,000 from the Medical Technology Enterprise Consortium (MTEC) for the development of its handheld predictive burn wound healing device, DeepView SnapShot M®. The company's R&D revenue has seen a significant increase, with projections for full-year 2024 R&D revenue to be approximately $28 million, marking a 55% year-over-year increase, as per an analysis by BTIG. Spectral AI's patent portfolio has also grown by 30%, now totaling 26 patents, which are integral to the company's future commercialization initiatives. Spectral AI has urged Nasdaq and state securities regulators in Florida, Louisiana, and Texas to investigate possible manipulative trading practices affecting its stock, with board member and largest shareholder, Erich Spangenberg, leading this effort. Finally, Spectral AI has announced collaborations with PolyNovo Limited and the expansion of its clinical trial sites for the 2024 Burn Pivotal Study, adding the University of California San Diego and the University of Utah to its network. These are recent developments for Spectral AI. As Spectral AI, Inc. (NASDAQ:MDAI) continues to make strides in the medical diagnostics field with its DeepView® System, the company's financial metrics provide a broader view of its market position. With a market capitalization of $17.78 million, Spectral AI is a relatively small player in the healthcare technology space, but its focus on AI-driven solutions for burn treatment could position it for growth as it seeks FDA classification for its DeepView AI®-Burn system. According to the latest data from InvestingPro, Spectral AI's revenue over the last twelve months as of Q2 2024 stands at $22.53 million, with a modest revenue growth of 0.3%. The company's gross profit margin during the same period is 45.12%, indicating a strong ability to control the cost of goods sold relative to revenue. However, the company faces challenges, as reflected by an operating income margin of -51.84%, suggesting significant operating expenses relative to its revenue. InvestingPro Tips for Spectral AI highlight that the stock is currently trading near its 52-week low and has experienced a significant price drop over the last year. These insights suggest that investors have concerns about the company's short-term profitability, as analysts do not anticipate the company will be profitable this year. The stock has also been identified as oversold according to the RSI metric, which could indicate a potential turning point for investors looking for entry points in the stock's valuation. For those interested in a more comprehensive analysis, InvestingPro offers additional insights on Spectral AI, Inc., with further tips available at: https://www.investing.com/pro/MDAI

Spectral AI Achieves 25% Patient Enrollment at Emergency Departments for U.S. Burn Pivotal Study and Adds Two New Clinical Trial Sites - Spectral AI (NASDAQ:MDAIW), Spectral AI (NASDAQ:MDAI)

DALLAS, Sept. 24, 2024 (GLOBE NEWSWIRE) -- Spectral AI, Inc. 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. 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 ("DeepView AI®-Burn"). "We are continuing to build momentum and advance towards achieving our ED enrollment goals," said Peter M. Carlson, Chief Executive Officer of Spectral AI. "Access to specialized burn treatment in the United States has declined significantly, resulting in an increasing number of front-line ED clinicians assuming the initial responsibility of assessing the severity and healing trajectory of a burn wound. We believe that the use of DeepView AI®-Burn can deliver burn expert-level clinical support to a busy, oftentimes chaotic, ED setting." As previously announced, the Company has completed both adult and pediatric patient enrollment at U.S. burn centers for the U.S. Burn Pivotal Study. Using data from these burn center patients, the Company will pursue a De Novo submission to the U.S. Food and Drug Administration ("FDA") requesting classification of DeepView AI®-Burn as a Class II medical device. The Company expects to submit this request to the FDA in the second quarter of 2025. Spectral AI's DeepView® System for burn indication is designed to distinguish between healing and non-healing tissue by providing an immediate and binary prediction of wound healing on Day One that can support clinical decision-making regarding next step treatment plans. 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 and diabetic foot ulcers. 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 device that offers clinicians 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 change the current standard of care, the DeepView® System is expected to provide faster and more 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. 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. Investors: The Equity Group Devin Sullivan Managing Director dsullivan@equityny.com Conor Rodriguez Analyst crodriguez@equityny.com Market News and Data brought to you by Benzinga APIs