Perimeter Medical Imaging AI (TSX-V:PINK) (OTC:PYNKF) announced positive topline results from the pivotal study designed to support its planned FDA PMA submission for approval to market its next-generation Perimeter B-Series OCT system, which combines proprietary artificial intelligence (AI) technology with wide field optical coherence tomography (OCT), for use during breast-conserving surgeries in the United States.
The study results indicated that the B-Series OCT with ImgAssist AI 2.0 system enabled surgeons to more effectively address residual cancer at the surgical margin during surgery as compared to current standard methods. The pivotal trial met its primary endpoint, achieving a statistically significant (p-value = 0.0050) reduction in patients with residual cancer during surgery. These results demonstrate super-superiority (lower bound of confidence interval for treatment effect greater than a predetermined minimal clinically meaningful difference) of the Perimeter B-Series OCT with ImgAssist AI 2.0 system’s ability to aid surgeons in achieving clear surgical margins during surgery, potentially lowering the need for reoperation.
“These positive topline pivotal trial results are very encouraging for this patient population undergoing BCS,” said Dr. Sarah Butler, Perimeter’s Vice President, Clinical and Medical Affairs. “The trial easily met its primary endpoint, demonstrating that intraoperative margin assessment using OCT combined with Perimeter’s AI technology may be able to help lower re-excision rates by identifying regions of interest and guiding real-time decisions by surgeons on margin status in the OR. We are looking forward to submitting our FDA PMA for B-Series OCT with ImgAssist AI 2.0 in early 2025.”
“Surgeons have worked for years to innovate every step in the diagnosis and treatment plan for their cancer patients, with the ultimate goal of improving survivability and quality of life,” commented Adrian Mendes, Perimeter’s Chief Executive Officer. “The promise of B-Series OCT with ImgAssist AI 2.0 is greater peace of mind. Both for the surgeon who – no matter how skilled – currently faces nearly 1-in-5 odds of needing to perform repeat surgery due to positive margins; and for their patient, who under the current paradigm, typically has to wait (and worry) for up to seven days for their surgeon to receive a post-operative pathology report which will determine whether they will have to go through the emotional and physical trauma of a second surgery due to cancer left behind. We believe that, based on these positive topline pivotal trial results, we are well-positioned to make a real difference in the treatment of cancer patients; and should the FDA approve the PMA, B-Series OCT with ImgAssist AI 2.0 has the potential for rapid acceptance and adoption by [breast cancer] surgeons in the United States.”
Perimeter is hosting a conference call and audio webcast today at 5:00 pm Eastern Time to discuss the pivotal trial topline results.
