– Intraoperative margin assessment during BCS using Perimeter B-Series OCT with ImgAssist AI 2.0 enabled surgeons to more effectively address residual cancer at the surgical margin as compared to current standard methods – – Primary endpoint met with statistically significant reduction in patients with residual cancer during surgery (p-value = 0.0050) – – B-series super-superiority based on predefined clinical and statistical significance parameters – – FDA PMA application for B-Series OCT system with ImgAssist AI expected to be submitted in early 2025 – – Perimeter Medical Imaging AI to host conference call/webcast today at 5 pm ET – TORONTO and DALLAS , Nov.
20, 2024 /PRNewswire/ - Perimeter Medical Imaging AI, Inc. (TSXV: PINK) (OTC: PYNKF) ("Perimeter" or the "Company"), a commercial-stage medical technology company, today announced positive topline results from the pivotal study designed to support its planned Premarket Approval Application ("PMA") submission to the U.S.
Food and Drug Administration ("FDA") for approval to market the Company's next-generation Perimeter B-Series OCT system, which combines proprietary artificial intelligence ("AI") technology with optical coherence tomography ("OCT"), for use during breast-conserving surgeries ("BCS") in the United States . In this prospective, multi-center, randomized, clinical trial, 206 breast cancer patients undergoing BCS for the treatment of Stage 0-III invasive ductal carcinoma and/or ductal carc.
