Perimeter Medical Imaging AI, Inc. provided an update on the clinical development of its ongoing clinical trial evaluating the use of Perimeter B-Series OCT combined with its proprietary ImgAssist AI software during breast conservation surgery. Based on feedback from the U.S. Food and Drug Administration ("FDA"), the Company has reached alignmen on key elements of the ongoing clinical trial, including the introduction of an interim analysis, which is expected in the second quarter of 2024. Summary of Clinical Trial Updates.

Clearance to introduce enhanced AI algorithm. Perimeter received approval from the FDA to introduce an enhanced AI algorithm in the ongoing clinical trial under the existing study protocol. As a result, all clinical trial sites will use the updated AI as patients continue to enroll in the ongoing study.

Enrollment of additional subjects. In order to obtain statistically significant findings based on the use of the new AI algorithm, Perimeter is permitted to enroll up to 531 subjects. Introduction of interim analysis within study protocol.

If statistically significant positive interim results are obtained, the Company may opt to conclude the trial and begin preparing regulatory submissions supporting market clearance. If it is determined that more data is needed, the Company may continue with its clinical trial. and anticipates study completion by the end of 2024.

Additional clinical trial sites permitted. To further support and expedite patient enrollment, Perimeter has received clearance to increase the number of clinical trial sites, most recently adding Mayo Clinic and Baptist MD Anderson in Florida. Summary of anticipated AI improvements.

The new enhanced AI takes advantage of additional training data and Perimeter's latest AI advancements that demonstrate improved sensitivity, specificity, precision, and recall.