On January 11, 2022 Perimeter Medical Imaging AI, Inc. (TSX-V:PINK) (OTC:PYNKF) (FSE:4PC) ("Perimeter" or the "Company"), a medical technology company driven to transform cancer surgery with ultra-high-resolution, real-time, advanced imaging tools to address high unmet medical needs, reported the expansion of its ongoing pivotal study to include an additional clinical trial site at Baylor College of Medicine in Houston, TX, under the direction of Dr. Alastair Thompson, Principal Investigator of the study (Press release, Perimeter Medical Imaging AI, JAN 11, 2022, View Source [SID1234598597]).
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A multi-center, randomized, two-arm clinical trial is underway to measure the effectiveness of the Perimeter B-Series OCT imaging platform combined with ImgAssist artificial intelligence (AI) technology in reducing the number of unaddressed positive margins in breast lumpectomy procedures when used in addition to standard intraoperative margin assessment. Approximately 300 patients undergoing breast conservation surgery across eight U.S. clinical sites are expected to participate in the pivotal trial, with study completion anticipated by the end of 2022.
Dr. Alastair Thompson, Professor, Section Chief of Breast Surgery, and Olga Keith Wiess Chair of Surgery at Baylor College of Medicine and Co-associate Director for Clinical Research at the Dan L Duncan Comprehensive Cancer Center, stated, "Failure to get clear margins in breast cancer surgery is a critical problem that can lead to further complications for patients due to re-operations and higher costs to the overall healthcare system. This pioneering technology allows surgeons to examine an excised tissue sample and identify areas of concern to support ‘real-time’ margin assessment during a surgery."
Dr. Thompson continued, "Having participated in earlier stages of Perimeter’s ATLAS AI project – including contributing to the collection of breast tumor images in order to develop and train the artificial intelligence algorithm – I am excited to act as principal investigator of this pivotal study."
Jeremy Sobotta, Perimeter’s Chief Executive Officer stated, "We are proud to partner with leading cancer centers like Baylor to enable the late-stage clinical development of our breakthrough-device-designated Perimeter B-Series OCT platform that includes AI-assisted software. We are also grateful for the grant funding that we received from the Cancer Prevention and Research Institute of Texas (CPRIT), which has supported our ATLAS AI project across multiple stages, culminating in this important pivotal study now underway. We believe our technology has the potential to help breast cancer surgeons improve outcomes for patients and we look forward to analyzing the data from this study, which is expected to be completed by the end of the year."
About the Clinical Development of Perimeter B-Series OCT with ImgAssist AI
Perimeter is advancing the clinical development of its proprietary, next-gen "ImgAssist" artificial intelligence (AI) technology under its ATLAS AI project, which is made possible, in part, by a US$7.4 million grant awarded by the Cancer Prevention and Research Institute of Texas (CPRIT). The U.S. FDA granted Breakthrough Device Designation for Perimeter B-Series OCT + ImgAssist AI, which has the potential to aid surgeons in identifying regions of interest on scanned samples, enabling them to make key decisions on margin status real-time intraoperatively. Perimeter B-Series + ImgAssist AI is currently approved for "Investigational Use Only" in the U.S., which means that at this time, only select surgeons have access to this technology by participating in the ongoing pivotal clinical trial.
About Perimeter S-Series OCT
Cleared by the U.S. FDA with a general tissue indication, Perimeter S-Series Optical Coherence Tomography (OCT) is a novel medical imaging system that provides clinicians with cross-sectional, real-time margin visualization (1-2 mm below the surface) of an excised tissue specimen. Giving physicians the ability to visualize microscopic tissue structures "real time" in the operating room has the potential to result in better long-term outcomes for patients and lower costs to the healthcare system.