Perimeter Medical Imaging AI, Inc., a commercial-stage medical technology company – 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 alignment on key elements of the ongoing clinical trial, including the introduction of an interim analysis, which is expected in the second quarter of 2024.
Adrian Mendes, Perimeter’s Chief Executive Officer stated, “This positive interaction with the FDA marks an important milestone in our clinical development program. As a first step, we received regulatory approval to implement our substantially enhanced AI algorithm in the ongoing pivotal clinical trial under the existing study protocol, and we have now aligned on other key elements in order to chart a clear path forward for the development of our B-Series OCT with ImgAssist AI.”
Mr. Mendes continued, “Importantly, we will have a planned interim analysis in the trial, which will provide us with an early read-out of results based on the use of the newest algorithm. If key endpoints are met at the time of the interim analysis, we may opt to conclude the trial and begin preparing regulatory submissions supporting market clearance. Alternatively, the interim analysis could support continuing the trial to build a stronger submission package from additional subjects. Ultimately, our goal is to expedite the development of our next-gen AI technology and deliver it to our surgeon customers to improve clinical and economic outcomes in breast surgical oncology.”
Dr. Alastair Thompson, Principal Investigator and Professor, Section Chief of Breast Surgery, and Olga Keith Wiess Chair of Surgery at Baylor College of Medicine and Co-associate Director for Clinical Research at the Dan L Duncan Comprehensive Cancer Center, stated, “Having participated in earlier stages of its development, and as principal investigator of the study, I am excited that the clinical trial continues to advance and gather additional clinical data using the updated AI software. There is a strong need for new tools to assist surgeons with ‘real-time’ margin assessment in the operating room. I believe combining AI with high-resolution imaging has the potential to become a new standard of care during breast conservation surgery.”
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
- Perimeter intends to conduct a planned interim analysis in the second quarter of 2024. 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. It is expected that this updated version of ImgAssist AI will contribute to more accurate classification, as well as fewer false positives and negatives.
SOURCE: PRNewswire
