Spectral AI Expands Clinical Trial Sites and Strengthens Patent Portfolio

Spectral AI Adds Three New Clinical Trial Sites To Expedite Emergency Department Patient Enrollment By Investing.com

DALLAS, July 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 has added three new U.S. Clinical Trial Sites for its 2024 Burn Pivotal Study: University Medical Center (UMC) Burn Center at Texas Tech University Health Sciences Center led by principal investigator Alan Pang, M.D., Tampa General Hospital Burn Center led by principal investigator Jared Troy, M.D., and University of South Alabama (USA) Health Emergency Department led by Andrew Bright, D.O. These new locations expand the total number of U.S. Clinical Trial Sites to 16, comprised of both burn centers and Emergency Departments (EDs). The 2024 U.S. Burn Pivotal Study is designed to validate the AI-driven algorithm used by Spectral AI's DeepView™ System for burn indication. The study is expected to be the final clinical trial before the Company seeks FDA approval of its DeepView™ System for burn indication in 2025. We believe that the potential of our AI-driven DeepView™ System to support the timely and accurate triage of a burn wound patient in a busy, sometimes chaotic, ED setting can deliver benefits across the healthcare ecosystem, said Peter M. Carlson, Chief Executive Officer of Spectral AI. Having an objective diagnostic tool can lead to immediate interventions that impact the treatment and outcome of burn wounds, while supporting improved institutional efficiencies. The addition of these new sites brings us closer to completing the 2024 Burn Pivotal Study and seeking FDA approval for the DeepView™ System for burn indication in 2025. We are grateful for the support of these esteemed clinicians and institutions in supporting our research and bringing true innovation to burn wound assessment and treatment. The Company's DeepView™ System image processing algorithm utilizes multispectral imaging, trained and tested against a proprietary database of more than 340 billion clinically validated data points, to deliver a rapid and objective assessment that aids healthcare providers in assessing the healing potential of a burn wound. The U.S. pivotal study is currently enrolling patients at leading burn centers and EDs across the U.S., with esteemed principal investigators overseeing the research. 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. 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.

Spectral AI Adds Three New Clinical Trial Sites To Expedite Emergency Department Patient Enrollment

DALLAS, July 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 has added three new U.S. Clinical Trial Sites for its 2024 Burn Pivotal Study: University Medical Center (UMC) Burn Center at Texas Tech University Health Sciences Center led by principal investigator Alan Pang, M.D., Tampa General Hospital Burn Center led by principal investigator Jared Troy, M.D., and University of South Alabama (USA) Health Emergency Department led by Andrew Bright, D.O. These new locations expand the total number of U.S. Clinical Trial Sites to 16, comprised of both burn centers and Emergency Departments (EDs). The 2024 U.S. Burn Pivotal Study is designed to validate the AI-driven algorithm used by Spectral AI's DeepView™ System for burn indication. The study is expected to be the final clinical trial before the Company seeks FDA approval of its DeepView™ System for burn indication in 2025. "We believe that the potential of our AI-driven DeepView™ System to support the timely and accurate triage of a burn wound patient in a busy, sometimes chaotic, ED setting can deliver benefits across the healthcare ecosystem," said Peter M. Carlson, Chief Executive Officer of Spectral AI. "Having an objective diagnostic tool can lead to immediate interventions that impact the treatment and outcome of burn wounds, while supporting improved institutional efficiencies. The addition of these new sites brings us closer to completing the 2024 Burn Pivotal Study and seeking FDA approval for the DeepView™ System for burn indication in 2025. We are grateful for the support of these esteemed clinicians and institutions in supporting our research and bringing true innovation to burn wound assessment and treatment." The Company's DeepView™ System image processing algorithm utilizes multispectral imaging, trained and tested against a proprietary database of more than 340 billion clinically validated data points, to deliver a rapid and objective assessment that aids healthcare providers in assessing the healing potential of a burn wound. The U.S. pivotal study is currently enrolling patients at leading burn centers and EDs across the U.S., with esteemed principal investigators overseeing the research. 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. 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.

Spectral AI Announces Total U.S. and International Patent Portfolio Now Stands at 26 Granted Patents and 38 Pending Applications in Support of its AI-Driven DeepView System - Spectral AI (NASDAQ:MDAIW), Spectral AI (NASDAQ:MDAI)

DALLAS, July 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 a 30% increase in its patent portfolio that strengthens and protects its proprietary, AI-driven DeepView System wound assessment platform. Total patents granted to the Company increased to 26 through July 8, 2024 from 20 at December 31, 2023, consisting of 12 U.S. and 14 international patents. These patents cover various aspects of the Company's DeepView System platform, including, but not limited to, tissue classification based on multi-spectral imaging, machine learning and healthcare metrics, wound assessments based on multi-spectral imaging, optical biomarkers, machine learning and high precision imaging with multiplexed illumination. The Company continues to protect its data and processes with an additional 38 pending patent applications worldwide, consisting of seven pending U.S. patents and 31 pending international patents. The patents encompass nine distinct patent families. "These newly granted patents highlight the novel nature of our DeepView System platform and its ability to deliver an immediate, objective, and grounded assessment of a wound's healing potential," said Peter M. Carslon, Chief Executive Officer. "The DeepView System platform reflects years of significant investment in product development and our team is continuing to enhance the underlying technology. Together with our trademarks and trade secrets, these intellectual property assets are keys to our success and will serve as a foundation for our planned product commercialization initiatives set to commence in late 2024 and continuing through 2026." "We remain diligent in protecting and enhancing our proprietary technologies," said Erich Spangenberg, Spectral AI board member, a globally recognized IP expert, and the Company's largest shareholder. "I am actively engaged in supporting management as it builds and maintains a world-class moat around these critical assets." 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

Spectral AI boosts patent portfolio By Investing.com

DALLAS - Spectral AI, Inc. (NASDAQ:MDAI), a company specializing in AI-driven medical diagnostics, has announced a significant expansion of its patent portfolio. The Dallas-based firm reported a 30% increase in its number of patents, which now totals 26 as of July 8, 2024, up from 20 at the end of the previous year. These patents, including 12 U.S. and 14 international, support its DeepView System, a platform designed for advanced wound assessment. The company's patent growth encompasses a range of technologies integral to the DeepView System, such as tissue classification, machine learning, healthcare metrics, and high precision imaging. With an additional 38 patent applications pending globally, Spectral AI is reinforcing its intellectual property position in the medical diagnostics field. Peter M. Carlson, CEO of Spectral AI, emphasized the importance of these patents for the company's future, stating that they are crucial for the planned commercialization initiatives slated to begin in late 2024. The company's approach to wound care diagnostics aims to provide clinicians with an immediate, objective assessment of a wound's healing potential, which could lead to improved patient outcomes and reduced healthcare costs. Board member and the company's largest shareholder, Erich Spangenberg, highlighted the ongoing efforts to protect Spectral AI's proprietary technologies. Spangenberg, recognized for his expertise in intellectual property, is actively involved in building a "world-class moat" around these assets. Spectral AI focuses on predictive AI for faster and more precise treatment decisions in wound care, with initial applications targeting patients with burns and diabetic foot ulcers. The company's DeepView System is expected to shift the standard of care in wound management by providing algorithm-driven results that could transform treatment insights. Spectral AI has been making significant strides in its operations. The company reported a 24.6% increase in Research & Development revenue to $6.3 million for the first quarter, alongside an improved cash position of $10.2 million. Despite slower-than-expected enrollment in the company's pivotal Burn trial in the United States, Spectral AI still projects full-year 2024 R&D revenue to be approximately $28 million, marking a 55% year-over-year increase, according to an analysis by BTIG. Spectral AI has announced a collaboration with PolyNovo Limited to introduce its DeepView System for burn indication in Australia, aiming to deploy the system at two major hospitals in Adelaide and Melbourne. The company also expanded its clinical trial sites for the 2024 Burn Pivotal Study, adding the University of California San Diego and the University of Utah to its existing network. Spectral AI, Inc. (NASDAQ:MDAI) has been making significant strides in enhancing its intellectual property, a move that aligns with its ambitious commercialization plans. The company's focus on expanding its patent portfolio is a testament to its commitment to innovation and maintaining a competitive edge in the AI-driven medical diagnostics sector. InvestingPro data reveals a mixed financial picture for Spectral AI. With a market capitalization of $30.77 million, the company's financial health is reflected in its revenue figures, which show a decline of 21.53% in the last twelve months as of Q1 2024. However, it's worth noting that the quarterly revenue growth during Q1 2024 has been positive at 24.58%, suggesting a potential turnaround or seasonal strength in the company's performance. Despite the challenges, Spectral AI holds more cash than debt on its balance sheet, which could provide the financial flexibility needed to support its commercialization initiatives and further development of the DeepView System. This is a significant InvestingPro Tip, indicating the company's ability to manage its financial obligations and invest in growth opportunities without the immediate pressure of high debt levels. The company's stock has experienced volatility, with a substantial 83.36% decline in its price total return over the past year. Investors might view this as a potential entry point, especially if they believe in the company's long-term prospects and the value of its expanding patent portfolio. Moreover, Spectral AI does not pay a dividend to shareholders, which is typical for growth-oriented companies that prefer to reinvest earnings back into the business. For investors seeking a deeper analysis, InvestingPro offers additional tips on Spectral AI, which can be accessed at https://www.investing.com/pro/MDAI. There are 6 more InvestingPro Tips available, providing insights that could help investors make informed decisions. To benefit from the full range of features, including these tips, use coupon code PRONEWS24 to get up to 10% off a yearly Pro and a yearly or biyearly Pro+ subscription. The company's next earnings date is set for September 13, 2024, which will be a critical event for investors to gauge the company's progress and the impact of its patent expansion on financial performance. With the InvestingPro Fair Value estimated at $2.38, compared to the analyst target of $4.00, the market will be watching closely to see if Spectral AI's strategic initiatives translate into shareholder value.