Perimeter Medical Imaging AI Announces Initiation of First Clinical Trial Site
at West Cancer Center & Research Institute in Tennessee
Pivotal study to determine the impact of Perimeter B-Series OCT with ImgAssist AI on positive margin rates during breast conservation surgery
Perimeter Medical Imaging AI, Inc., a medical technology company driven to transform cancer surgery with ultra-high-resolution, real-time, advanced imaging tools to address high unmet medical needs, announced the initiation of a multi-center, randomized, two-arm pivotal clinical trial to evaluate its Perimeter B-Series OCT with ImgAssist AI for use during breast conservation surgery. The first patient procedures were performed by Richard E. Fine, MD and Michael Berry, MD, leading breast surgeons based out of the Margaret West Comprehensive Breast Center in Germantown, Tennessee.
Dr. Richard E. Fine, Director of Education & Research, Margaret West Comprehensive Breast Center, West Cancer Center & Research Institute, stated, “We are excited to be the first site to enroll a patient in the Perimeter pivotal trial that is evaluating the use of Perimeter B-Series OCT imaging technology combined with artificial intelligence. There is a strong unmet medical need to provide breast cancer surgeons with specimen imaging tools to aid their decisions ‘real time’ in the operating room. Through this pivotal study, we can assess if the Perimeter B-Series with artificial intelligence demonstrates an improvement over the current standard of care – potentially setting a new standard for specimen imaging technology during breast conservation surgery.”
Dr. Michael Berry, Director of Margaret West Comprehensive Breast Center, commented, “Approximately 15% to 20% of women who undergo breast conservation surgery require reoperation if their surgeon fails to get clear margins. By combining optical coherence tomography with deep learning algorithms, this innovative technology could assist us, as surgeons, to better identify regions of interest on scanned samples, enabling ‘real-time’ decisions on margin status in the OR.”
Jeremy Sobotta, Perimeter’s Chief Executive Officer stated, “The initiation of this pivotal trial marks another milestone in our ATLAS AI project and an important step in the clinical development of our breakthrough-device-designated Perimeter B-Series OCT with AI assisted software, which represents the next generation of our commercially available flagship Perimeter S-Series OCT. Our hope is that clinical data generated from this study will provide supporting evidence that our technology can help breast cancer physicians improve outcomes for patients and potentially reduce the burden of additional costs within the healthcare system. We expect that this study will be completed by the end of 2022.”