Company description

We are an AI company focused on predictive medical diagnostics. Our DeepView System uses proprietary AI algorithms to distinguish between fully damaged, partially damaged and healthy human tissue characters invisible to the naked eye, at the initial time point of wound presentation. The DeepView System delivers a binary prediction on the wound’s capacity to heal or not-heal by a specified time point in the future. Our DeepView System’s output is specifically engineered to assist the health care professional in making a more accurate, timely and informed decision regarding the treatment of the patient’s wounds. Our focus is on our burn indication. We were notified that our DeepView System, comprised of the multispectral imaging (“MSI”) component integrated with the predictive AI-Burn ® software component, received United Kingdom Conformity Assessed (UKCA) marking for use in the United Kingdom for burn indications on February 22, 2024. The UKCA marking registration was fully completed on March 7, 2024. In 2026, we hope that our full DeepView System may achieve Class II medical device designation with the United States Food and Drug Administration (FDA) via the De Novo application the Company submitted in June of 2025. Subject to our receipt of additional necessary market authorization, our business will have two revenue streams, a SaaS (software as a service) model component predicated on utilizing the regulatory method, a SaMD (software as a medical device) regulatory framework, and the imaging device component.

Read the full filing description · filed 25 Mar 2026

At a glance

Sector

Healthcare

Industry

Surgical & Medical Instruments & Apparatus