Perimeter Announces Completion of Patient Enrollment in Pivotal Clinical Trial Evaluating OCT B-Series with ImgAssist AI in Breast-Conserving Surgeries

Core Insights - Perimeter Medical Imaging AI, Inc. has developed the Perimeter B-Series OCT system, which integrates AI with optical coherence tomography for margin assessment during breast-conserving surgeries, aiming to reduce high reoperation rates associated with breast cancer surgeries [1][4] Group 1: Clinical Trial and Results - A pivotal study has completed patient enrollment, involving approximately 530 women undergoing breast-conserving surgery for Stage 0-III invasive ductal carcinoma [2][3] - The primary endpoint of the trial is to evaluate the occurrence of unaddressed positive margins, with a within-subject analysis planned [3] - Results from the pivotal trial are expected in Q4-2024, which could support a submission to the FDA in 2025 [1][4] Group 2: Market Implications - If successful, the B-Series OCT system could receive the first-ever marketing clearance for specific use in breast tissue and margin evaluation, representing a significant milestone for Perimeter's business [1][4] - The technology aims to empower surgeons with real-time intraoperative tools to improve margin assessment and potentially lower re-excision rates, setting a new standard in specimen imaging technology [4] Group 3: Financial and Operational Context - The company has received a grant of up to US$7.4 million from the Cancer Prevention and Research Institute of Texas to support the clinical trial [6] - The Perimeter S-Series OCT system is already FDA-cleared for general indications, while the B-Series is currently investigational and not available for sale in the U.S. [6][7]