Perimeter Medical Imaging AI (TSXV:PINK; OTC:PYNKF) has announced the completion of patient enrollment in a pivotal clinical study evaluating its next-generation Perimeter B-Series OCT system, which combines proprietary AI technology with optical coherence tomography (OCT) during breast conserving surgeries (BCS).
The Perimeter OCT B-Series is the first system designed to combine AI with OCT for margin assessment, aiming to reduce the unacceptably high reoperation rates associated with BCS. The company is seeking first-ever marketing authorization for specific use in breast tissue, breast cancer, and margin evaluation. If obtained, it would represent a critical milestone for Perimeter.
The clinical trial enrolled roughly 530 women, aged 18 and older, undergoing BCS for early to advanced breast cancer. Approximately 200 participants will be evaluated specifically to demonstrate the effectiveness of the Perimeter B-Series OCT system in addressing positive margins compared to the standard lumpectomy procedure, with additional analyses focused on safety, breast appearance, and other cancer detection outcomes.
“It is very exciting that the pivotal trial has completed enrollment in such a timely manner,” said Dr. Alastair Thompson, the trial’s primary principal investigator, surgeon, and professor, section chief of breast surgery, Olga Keith Weiss Chair of Surgery at Baylor College of Medicine, and breast cancer program leader at the Dan L Duncan Comprehensive Cancer Center.”
“Today, intraoperative margin assessment remains one of the most pressing problems for both surgeons and their patients. Perimeter’s AI technology empowers surgeons with a dedicated intraoperative tool to identify regions of interest and guide real-time decisions on margin status in the OR. The goal is to determine whether this technology can help lower re-excision rates – potentially setting a new standard for specimen imaging technology during BCS. There has been a smooth collaboration between the clinical trial sites and Perimeter, and we all are looking forward to seeing the final results,” Dr. Thompson added.
Adrian Mendes, CEO of Perimeter, commented, “We are pleased patient enrollment has now been completed and look forward to sharing the primary endpoint results of this pivotal study with our stakeholders prior to the end of 2024. If successful, the trial is expected to support our submission in 2025 to the U.S. Food and Drug Administration for authorization to market B-Series OCT with ImgAssist AI in the U.S.”
