Perimeter Medical Imaging AI, Inc. (TSXV: PINK) (OTC: PYNKF) has announced the completion of patient enrollment in its pivotal clinical trial evaluating the Perimeter B-Series OCT system during breast-conserving surgeries (BCS). The study aims to address the high reoperation rates associated with BCS due to missed margins, which currently range from 14% to 21%.
The prospective, multi-center, randomized, double-arm clinical trial enrolled approximately 530 women aged 18 years and older across 10 clinical sites in the United States. Participants undergoing BCS for Stage 0-III invasive ductal carcinoma and/or ductal carcinoma in situ were randomized in a 2:1 ratio to the device and control arms.
Study Design and Endpoints
Approximately 200 subjects will be used to evaluate the effectiveness of the Perimeter B-Series, which integrates OCT imaging with the ImgAssist 2.0 AI algorithm. The primary endpoint is the occurrence of at least one unaddressed positive margin for a subject, assessed via within-subject analysis. Secondary and exploratory endpoints include evaluations of safety outcomes, cosmesis results, and positive cancer results at the margin and patient levels.
Expert Commentary
"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 Wiess Chair of Surgery at Baylor College of Medicine, 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."
Company Outlook
"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," commented Adrian Mendes, Perimeter's Chief Executive Officer. "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 United States."
