Spectral MD, a company that specializes in predictive analytics, completed enrolment for a burn artificial intelligence (AI) training study in the United States on Monday. This study was supported by the Biomedical Advanced Research and Development Authority (BARDA). The study was intended to test its proprietary AI algorithms and optical technology for wound care.
To complete the ‘DeepView AI-Burn’ algorithm, the team used data collected from adult and paediatric subjects enrolled in the study to make sample size determinations for its US burn AI validation study, which will start in the second half of this year. The training study was conducted across 11 leading burn centres in the US and was further expanded in August last year to include additional paediatric sites and emergency departments thanks to BARDA’s support.
The completion of enrolment for the study fulfilled the company’s contractual requirements with BARDA, with Spectral MD now focused on completing the necessary requirements for the upcoming validation study. The validation study will generate an independent dataset with subjects enrolled across different US study sites from the training study. This is a requirement for the US Food and Drug Administration (FDA) to remove bias from the results ahead of the company’s DeepView AI-Burn FDA regulatory submission, planned for 2024.
Spectral MD Holdings CEO Wensheng Fan commented, “The completion of enrolment in our burn AI training study represents a significant milestone for Spectral MD, as it meets our contractual obligations with BARDA, paving the way for the final stage of clinical development for DeepView AI-Burn. With BARDA’s invaluable support, we anticipate initiating our burn AI validation study in the second half of 2023, and we remain committed to our partnership to deliver a non-invasive imaging platform for the US government that enables physicians to accurately and instantaneously assess the severity of burns in mass-casualty events.”
Spectral MD Holdings Inc is one of the leading companies in predictive analytics and is headquartered in Austin, Texas. It specializes in the development of innovative algorithms and technologies to help medical practitioners more effectively diagnose and treat patient diseases. Founded in 2011, it is a publicly-traded company on the AIM Market Exchange and is dedicated to helping improve clinical decision making for healthcare professionals and medical device companies.
The CEO of Spectral MD Holdings Inc, Wensheng Fan, is an experienced medical technology executive with over two decades of experience in medical device commercialisation, healthcare IT and informatics, and medical imaging. He is a graduate from the University of Massachusetts with a degree in Electrical & Computer Engineering and went on to pursue a MS degree in Biomedical Engineering from the same institution. Wensheng has held multiple executive and C-level positions in various enterprises, and has an extensive track record of success in advancing medical technologies and their adoption in the healthcare landscape.
Spectral MD’s innovative AI-Burn technology has great potential to improve the speed of assessments and treatments in care settings, while also giving clinicians valuable insights into patient needs. With the support of BARDA and completion of enrolment for the study, the team is now one step closer to achieving their goal of submitting the DeepView AI-Burn FDA regulatory submission in 2024.
