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Spectral AI Inc is an AI company, focused on predictive medical diagnostics. Spectral is devoting substantially all of its efforts towards the research and development of its DeepView System, an internally developed MSI device that has designated FDA BDD status. Its DeepView System uses proprietary algorithms to distinguish between damaged and healthy human tissue invisible to the naked eye, providing Day One healing assessments in seconds. The Company's output is specifically engineered to allow the physician to make a more accurate, timely, and informed decision regarding the treatment of the patient's wound.
Latest News: DALLAS, April 30, 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 received the Commitment to Quality Achievement Award from the Texas Manufacturer Assistance Center (TMAC) for their UKCA Mark Attainment. “Spectral AI is honored to be recognized as an upcoming leader in the Texas Manufacturing space,” said Louis Percoco, Spectral AI’s General Manager. “Our mission is to bring innovation and solutions to wound care through the company’s DeepView™ technology with the utmost quality and a strong manufacturing backbone is vital as we continue driving towards commercialization of the product. We are proud to be part of the local business infrastructure and appreciate the support and recognition for the focus the team brought to the table by the Texas manufacturing community.” TMAC, which is associated with the Manufacturing Extension Partnership (MEP) of the National Institute of Standards and Technology (NIST) aims for Texas manufacturers to achieve profitable growth and increased competitiveness. The non-profit program supports Texas manufacturers by granting business management consulting services, new technologies implementation, operations streamlining, workforce development, and strategic planning. Their services extend beyond manufacturers and also include distribution, logistics, construction, healthcare, and government entities. This award heralds in a new era of quality excellence and leadership for Spectral AI as they move toward product commercialization.
Spectral AI (Nasdaq: MDAI) announced a podium presentation at the BBA/ISBI Joint Conference by Dr. Jeffrey Carter, showcasing data from an ongoing study on their DeepView™ System. This AI-driven technology uses multispectral imaging to assess burn wound severity with accuracy exceeding experienced physicians. The presentation highlights the potential of DeepView™ to address challenges in burn care, including resources and the need for accurate diagnoses.
The company's 2024 U.S. Burn Pivotal Study is ongoing, aiming to validate the AI algorithm before seeking FDA approval in 2025. Spectral AI believes their system can significantly impact the speed, treatment, and outcomes for acute burn wound patients, especially in mass casualty events where current healthcare systems face constraints.
Spectral AI (NASDAQ: MDAI) reported Q2 2024 financial results, highlighting $7.5 million in Research & Development Revenue, a 76% increase from Q2 2023. The company's U.S. Burn Pivotal Study has exceeded 85% enrollment, paving the way for FDA submission in early 2025. Spectral AI maintains a cash position of $6.9 million and is on track to generate its first commercial revenues in the U.K. later this year.
Key developments include:
- Progress in handheld burn wound diagnostic technology
- Collaboration with PolyNovo for Australian market entry
- Addition to Russell Microcap® Index
- Deployment of five DeepView Burn devices in the U.K.
The company reiterates its FY 2024 revenue guidance of approximately $28.0 million.
Spectral AI (Nasdaq: MDAI) announced progress in developing DeepView SnapShot® M, a handheld diagnostic tool for battlefield burn assessment. The device, based on the Company's AI-driven DeepView™ System platform, aims to provide quick and accurate wound assessment for prioritizing evacuation in combat settings. Key advancements include:
1. Miniaturization of five cameras without compromising wavelength depth or accuracy
2. Image capture time under one second
3. Optimization for field-based settings with reduced unwanted light
An abstract on the device's development has been accepted for poster presentation at the 2024 Military Health System Research Symposium (August 26-29, 2024).
Spectral AI (Nasdaq: MDAI), an AI company specializing in medical diagnostics for wound care, has announced its schedule for reporting 2024 second quarter financial results. The company will release its financial report on Monday, August 12, 2024, after the stock market closes. Following the release, Spectral AI will host a conference call at 5:00 pm Eastern Time to discuss the results.
Investors interested in participating in the live call can dial 833-630-1956 for U.S. callers or 412-317-1837 for international callers. Additionally, a simultaneous webcast of the call will be accessible from the Events & Presentations section of the company's Investor Relations page at https://investors.spectral-ai.com/news-events/events.
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.
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