Welcome to our dedicated page for Spectral AI news (Ticker: MDAI), a resource for investors and traders seeking the latest updates and insights on Spectral AI stock.
Spectral AI, Inc. (Nasdaq: MDAI) is an artificial intelligence company dedicated to advancing medical diagnostics, particularly in wound care. The company's flagship product, the DeepView™ System, is a cutting-edge multispectral imaging (MSI) device designed to assist physicians in making accurate and timely treatment decisions. This innovative technology leverages proprietary algorithms to differentiate between damaged and healthy tissue, producing critical Day One healing assessments within seconds.
Spectral AI's DeepView System has received FDA Breakthrough Device Designation due to its potential to significantly improve patient outcomes. The primary focus of the company lies in the research and development of this system. Notably, a substantial portion of its funding comes from the Biomedical Advanced Research and Development Authority (BARDA), a division of the U.S. Department of Health and Human Services.
In recent developments, Spectral AI was honored with the Commitment to Quality Achievement Award by the Texas Manufacturer Assistance Center (TMAC) for their attainment of the UKCA Mark. This accolade underscores the company’s dedication to maintaining the highest standards of quality while working towards the commercialization of DeepView technology.
The company frequently updates its stakeholders through conference calls and presentations, which can be accessed via the investor relations section of its website. This proactive communication strategy ensures transparency and keeps investors well-informed about the company's progress and financial health.
Investor Relations Contacts:
Devin Sullivan, Managing Director at The Equity Group, can be reached at dsullivan@equityny.com.
Conor Rodriguez, Analyst at The Equity Group, can be contacted at crodriguez@equityny.com.
Media Contacts:
David Schull of Russo Partners can be reached at david.schull@russopartnersllc.com or (858) 717-2310.
Spectral AI (Nasdaq: MDAI) has announced a 30% increase in its patent portfolio, strengthening its proprietary AI-driven DeepView System for wound assessment. The company now holds 26 granted patents (12 U.S. and 14 international) and 38 pending applications worldwide. These patents cover various aspects of the DeepView System, including tissue classification, machine learning, and high-precision imaging.
CEO Peter M. Carlson emphasized the novel nature of the DeepView System and its ability to provide immediate, objective wound healing assessments. The company plans to commence product commercialization initiatives in late 2024 through 2026. Board member Erich Spangenberg, a recognized IP expert and the company's largest shareholder, is actively supporting management in building a strong intellectual property position.
Spectral AI (Nasdaq: MDAI) has added three new U.S. Clinical Trial Sites for its 2024 Burn Pivotal Study, bringing the total to 16 sites including burn centers and Emergency Departments. The new sites are:
- University Medical Center Burn Center at Texas Tech University Health Sciences Center
- Tampa General Hospital Burn Center
- University of South Alabama Health Emergency Department
The study aims to validate the AI-driven algorithm used by Spectral AI's DeepView™ System for burn indication. It's expected to be the final clinical trial before seeking FDA approval in 2025. The DeepView™ System uses multispectral imaging and a database of over 340 billion clinically validated data points to provide rapid, objective burn wound assessments.
Spectral AI (Nasdaq: MDAI), an AI company focused on medical diagnostics for wound care, has provided an update on its efforts to expose potential market manipulation of its common stock, primarily through naked short selling. The company's largest shareholder, Erich Spangenberg, sent letters to Nasdaq and state securities authorities in Florida, Louisiana, and Texas on June 24, 2024, highlighting potential violations of Nasdaq rules and federal and state laws. A follow-up letter dated July 15, 2024, urges authorities to investigate the likely prevalence of naked short selling affecting MDAI shares and other de-SPAC transaction companies. The company has filed these letters via Form 8-K with the SEC, making them publicly available.
Spectral AI (Nasdaq: MDAI) has signed an MOU with PolyNovo to potentially deploy its DeepView System for burn indication in Australia. The agreement aims for deployment at Royal Adelaide Hospital and The Alfred Hospital in Melbourne under Australia's Special Access Scheme (SAS). Spectral AI’s DeepView System provides clinicians with immediate, objective assessments of burn wounds using a predictive device based on multispectral imaging and a large, clinically validated database. This collaboration seeks to enhance patient care and familiarize Australian clinicians with the DeepView System, leveraging PolyNovo’s established presence in burn wound therapy.
Spectral AI (Nasdaq: MDAI) announced the addition of two new clinical trial sites at the University of California San Diego and the University of Utah, expanding its 2024 U.S. Burn Pivotal Study sites to 14. This expansion aims to capture more burn patients from emergency departments, diversify the patient population, and advance towards completing the study by the end of the year. The study will validate the AI-driven algorithm of Spectral AI's DeepView™ System for burn indication, with an expected completion in Q4 2024. FDA approval of the DeepView™ System is anticipated in 2025.
Spectral AI has achieved full pediatric patient enrollment at burn centers for its 2024 pivotal U.S. burn study, aimed at validating its DeepView™ System's AI-driven algorithm for burn indications. This study, set to conclude in Q4 2024, is the final step before seeking FDA approval in 2025.
The company met enrollment goals in just six months, demonstrating strong support from investigators. Spectral AI continues to enroll pediatric and adult patients through emergency departments to further validate its DeepView™ algorithm.
The DeepView™ System, utilizing proprietary multispectral imaging and a vast, clinically validated database, aims to provide immediate, accurate assessments of pediatric burn wounds. This non-invasive, cart-based system can be used directly at the patient’s location, enhancing early treatment decisions and potentially improving patient outcomes.
Spectral AI (Nasdaq: MDAI), an AI-driven medical diagnostics company, announced its inclusion in the Russell Microcap Index as of June 28, 2024, with trading commencing on July 1, 2024. CEO Peter M. Carlson emphasized that this inclusion boosts the company's visibility among investors. The company is advancing the commercialization of its AI-driven DeepView System, aimed at providing immediate wound healing assessments for burns and diabetic foot ulcers (DFU). In June, 50% of clinical trial sites were enrolled to validate the burn algorithm of DeepView, with trial completion expected in Q4 2024 and FDA approval sought in 2025. The company received UKCA Authorization in February to start sales in the UK and anticipates its first commercial revenue in H2 2024. Research & Development revenue rose by 24.6% to $6.3 million in Q1 2024, and the company's cash position improved to $10.2 million. A multi-year contract worth up to $150 million was awarded by the US Government for DeepView's advanced development, adding to over $250 million in non-dilutive support from the government. The Russell Microcap Index, a widely used benchmark, includes $10.5 trillion in assets.
Spectral AI (Nasdaq: MDAI) announced it has surpassed 90% of its pediatric enrollment target in burn centers for its 2024 pivotal study to validate the AI-driven DeepView™ System. This study, set to be completed in Q4 2024, aims for FDA approval in 2025. The DeepView™ System uses proprietary multispectral imaging and a database of over 340 billion data points to accurately assess burn depth in children, who face unique challenges in burn treatment due to thinner skin and different systemic responses. Spectral AI's system aims to provide immediate, non-invasive assessments, reducing stress and uncertainty for pediatric burn patients and their families.
Spectral AI (Nasdaq: MDAI), a leading AI company in medical diagnostics for wound care, has announced its support for an inquiry into potential market manipulation of its common stock. The inquiry, spearheaded by board member and major shareholder Erich Spangenberg, focuses on the illegal practice of naked short selling, which has allegedly inflated the company's public float by over 40%. Spectral AI is collaborating with Nasdaq and state securities authorities in Florida, Louisiana, and Texas to address this issue, aiming to strengthen market transparency and protect investors.
Spectral AI (Nasdaq: MDAI) will participate in the Northland Capital Markets Virtual Growth Conference on June 25, 2024. CEO Peter M. Carlson and CFO Vincent S. Capone will engage in virtual one-on-one meetings with institutional investors.
The company's DeepView™ System, which leverages multispectral imaging and a database of over 340 billion clinically validated data points, aims to distinguish between healthy and damaged tissue for better wound care decisions.
In February 2024, Spectral AI received UKCA authorization for the DeepView™ System for burn indications and anticipates generating its first commercial revenue this year. The company plans to file additional regulatory submissions in the UK and US in 2024 and 2025, with expectations to expand its commercial revenue platforms over the next two years.
FAQ
What does Spectral AI, Inc. specialize in?
What is the DeepView System?
Has the DeepView System received any regulatory recognition?
Where does Spectral AI get its research funding?
What recent award has Spectral AI received?
How can investors stay updated on Spectral AI's progress?
Who are the media contacts for Spectral AI?
What is the role of BARDA in Spectral AI's operations?
What kind of assessments does the DeepView System provide?
Who are the investor relations contacts at Spectral AI?
