Perimeter Announces Completion of Patient Enrollment in Pivotal Clinical Trial Evaluating OCT B-Series with ImgAssist AI in Breast-Conserving Surgeries
– Perimeter OCT B-Series is the first system designed to combine AI with optical coherence tomography for margin assessment, with the aim of reducing the unacceptably high reoperation rates associated with BCS –
– Recent study1 published in the Annals of Surgical Oncology revealed reoperation rates of 21.1% among commercially insured women and 14.9% among the Medicare cohort –
– Primary endpoint results from OCT B-Series pivotal trial expected in Q4-2024; could support submission to FDA in 2025 –
– First-ever marketing clearance for specific use in breast tissue, breast cancer, and margin evaluation, if obtained, would represent a major inflection point for Perimeter’s business –
Perimeter Medical Imaging AI, Inc. (TSXV: PINK) (OTC: PYNKF) (“Perimeter” or the “Company”), a commercial-stage medical technology company, today announced the completion of patient enrollment in a pivotal study evaluating the use of its next-generation Perimeter B-Series OCT system, which combines proprietary artificial intelligence (“AI”) technology with optical coherence tomography (“OCT”), during breast-conserving surgeries (“BCS”).
Unfortunately, re-excision after BCS is a common problem with reoperation rates reported from 14 to 21%1 due to missed margins and leaving cancer behind. If Perimeter’s B-Series study is successful, it will have demonstrated a decrease in the number of patients where breast cancer was missed during surgery.
This prospective, multi-center, randomized, double-arm clinical trial enrolled approximately 530 women, aged 18 years and older, undergoing BCS for the treatment of Stage 0-III invasive ductal carcinoma and/or ductal carcinoma in situ. Participants were recruited from 10 clinical sites across the United States and randomized in a 2:1 ratio to the device and control arms.
Approximately 200 of these subjects will be used to evaluate the effectiveness of the Perimeter B-Series, which integrates OCT imaging with the ImgAssist 2.0 AI algorithm, in addressing positive margins as compared to the standard lumpectomy procedure. A within-subject analysis will be used to assess the primary endpoint, which is the occurrence of at least one unaddressed positive margin for a subject. In addition, several other analyses will be conducted, including evaluations of safety outcomes, cosmesis results, as well as secondary and exploratory endpoints that examine positive cancer results at the margin and patient levels.
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. There has been a smooth collaboration between the clinical trial sites and Perimeter, and we all are looking forward to seeing the final results.”
Adrian Mendes, Perimeter’s Chief Executive Officer, 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 United States.”
Perimeter Announces Completion of Patient Enrollment in Pivotal Clinical Trial Evaluating OCT B-Series with ImgAssist AI in Breast-Conserving Surgeries, source.
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