The company has added two university campuses in California and Utah. A day after hitting its pediatric enrollment goal, Spectral AI has expanded the scope of its pivotal burn study by adding two more clinical trial sites in the US.
The addition of UC San Diego and the University of Utah brings the total number of US clinical trial sites to 14.
The pivotal study (NCT06131203) is evaluating the US company’s AI wound diagnostic platform DeepView.
“These two new sites allow us to accept more burn patients coming in through the emergency room, complementing our existing trial sites in burn centers across the country, establishing our presence in new regions, and advancing our goal of completing this study by the end of the year,” said Peter Carlson, CEO of Spectral AI.
Expanding the clinical trial base allows access to a more diverse patient population and reduces bias, Carlson added. This is particularly important for imaging devices, where skin color and patient anatomy can affect outcomes. DeepView uses algorithms to analyze multispectral imaging of wounds against a database of burn biopsies. Spectral AIsays the device can help predict wound healing outcomes and support clinical decision making. Early assessment of the depth and severity of burns is critical to ensuring that patients receive appropriate care. According to analysis by GlobalData, the wound care management market is expected to reach a total of $38.8 billion by 2030, with a compound annual growth rate of 3.4%.
In addition to spectral imaging, lasers, optical cameras, and photoacoustic imaging are also used to assess burn depth.
Spectral AI, formerly known as Spectral MD, changed its name after a business combination with special purpose acquisition company (SPAC) Rosecliff Acquisition Corp I. The company’s technology was approved for adult use in the UK in February 2024 and is currently being evaluated in trials with a view to obtaining approval from the US Food and Drug Administration (FDA).
Spectral AI plans to complete the pivotal trial in the fourth quarter of 2024 and is expected to obtain approval in 2025.
In March 2024, the company signed contracts with the Defense Health Agency (DHA) and the US Army Medical Material Development Activity (USAMMDA). The goal of the funding is to support the development of a handheld version of its system for use by military personnel in the field.
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