DALLAS - Spectral AI, Inc. (NASDAQ:MDAI), an AI company specializing in medical diagnostics, has announced the addition of two new clinical trial sites in the United States for its 2024 Burn Pivotal Study. The University of California San Diego and the University of Utah will join the existing network, bringing the total to 14 locations nationwide.
This expansion aims to increase the diversity of the patient population and reduce potential bias in the study, which is crucial for the validation of Spectral AI's DeepView™ System. This AI-driven device is designed to assist clinicians in assessing the healing potential of burns more accurately and promptly.
Peter M. Carlson, CEO of Spectral AI, stated that the inclusion of these new sites is a strategic move to enhance the company's footprint across different geographies and to ensure a comprehensive data set for the study. The goal is to complete the study by the end of 2024, with the DeepView™ System expected to seek FDA approval for burn indication in 2025.
The DeepView™ System employs an algorithm to provide an immediate, objective assessment of a wound's healing potential, which could potentially shift the current standard of care in wound management. By providing faster and more accurate treatment insights, the system is anticipated to improve patient outcomes and reduce healthcare costs.
The company, headquartered in Dallas, focuses on predictive AI for faster and more accurate treatment decisions in wound care, with initial applications targeting patients with burns and diabetic foot ulcers.
The information reported is based on a press release statement from Spectral AI, Inc.
In other recent news, Spectral AI, a company specializing in artificial intelligence for medical diagnostics, has seen several significant developments. The company is set to join the Russell Microcap Index, a move expected to raise its profile among investment professionals. This inclusion is based on market-capitalization rankings and style attributes as defined by FTSE Russell.
Spectral AI has also reported a 24.6% increase in Research & Development revenue to $6.3 million for the first quarter ending March 31, 2024. This positive financial news is further bolstered by the company's improved cash position of $10.2 million.
In addition to these financial developments, Spectral AI has made strides in its product offerings. The company's DeepView™ System, an AI-driven predictive medical device, recently received UKCA Authorization, paving the way for sales in the UK. Furthermore, Spectral AI is advancing clinical studies in the United States and preparing for additional regulatory submissions in the US and UK in 2024 and 2025.
On the personnel front, Erich Spangenberg has been appointed as the CEO of Spectral IP, Spectral AI's healthcare IP subsidiary. Spangenberg, the company's largest shareholder, will lead the subsidiary in preparation for a potential spin-off.
Finally, BTIG has adjusted its price target on Spectral AI's shares, while retaining a Buy rating on the stock. This adjustment follows the company's first-quarter financial results for 2024. Despite a slower-than-expected enrollment in Spectral AI's pivotal Burn trial in the United States, the company forecasts full-year 2024 R&D revenue to be approximately $28 million, marking a 55% year-over-year increase.
InvestingPro Insights
As Spectral AI, Inc. (MDAI) broadens its clinical trial sites for its innovative DeepView™ System, investors may want to consider several financial metrics and expert insights from InvestingPro that could impact their investment decisions.
According to InvestingPro data, MDAI holds a market capitalization of $31.64 million, reflecting the company's valuation in the market. This relatively small market cap suggests that Spectral AI is a micro-cap stock, which often means it could have higher volatility and potential for growth, albeit with increased risk.
The company has experienced a significant return over the last week with a 7.74% price total return, as well as a strong return over the last month at 13.12%. This positive short-term performance, highlighted in the InvestingPro Tips, might indicate increasing investor confidence or positive market reactions to recent company developments, such as the expansion of clinical trial sites.
Despite these short-term gains, it's important to note that the company's price has fallen significantly over the last year, with an 82.73% decrease in the 1-year price total return. Investors should be aware that the company's financials also reflect challenges; MDAI is not currently profitable, and analysts do not anticipate profitability this year, as per additional InvestingPro Tips.
For those interested in further insights, there are additional InvestingPro Tips available at https://www.investing.com/pro/MDAI. Investors can use the coupon code PRONEWS24 to get up to 10% off a yearly Pro and a yearly or biyearly Pro+ subscription, which includes access to comprehensive analysis and tips that could guide investment decisions.
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