Perimeter Medical Imaging AI (TSX-V:PINK, OTC:PYNKF) told investors that feedback from the US Foods and Drug Administration shows alignment on key elements of its ongoing clinical trial evaluating the use of its B-Series OCT combined with its proprietary ImgAssist AI (artificial intelligence) software during breast conservation surgery.
The company said in a statement that the alignment includes the introduction of an interim analysis, which is expected in the second quarter of 2024.
“This positive interaction with the FDA marks an important milestone in our clinical development program,” Perimeter CEO Adrian Mendes commented.
“As a first step, we received regulatory approval to implement our substantially enhanced AI algorithm in the ongoing pivotal clinical trial under the existing study protocol, and we have now aligned on other key elements in order to chart a clear path forward for the development of our B-Series OCT with ImgAssist AI.”
Mendes noted that the planned interim analysis in the trial will provide Perimeter with an early read-out of results based on the use of the newest algorithm.
If key endpoints are met at the time of the interim analysis, the company may opt to conclude the trial and begin preparing regulatory submissions supporting market clearance. Alternatively, the interim analysis could support continuing the trial to build a stronger submission package from additional subjects.
“Ultimately, our goal is to expedite the development of our next-gen AI technology and deliver it to our surgeon customers to improve clinical and economic outcomes in breast surgical oncology,” Mendes added.
Principal investigator of the study Dr Alastair Thompson stated: “I am excited that the clinical trial continues to advance and gather additional clinical data using the updated AI software. There is a strong need for new tools to assist surgeons with 'real-time' margin assessment in the operating room. I believe combining AI with high-resolution imaging has the potential to become a new standard of care during breast conservation surgery."
Based in Toronto and Dallas, Perimeter is a medical technology company focusing on ultra-high-resolution, real-time, advanced imaging tools for cancer surgery.
Contact the author at stephen.gunnion@proactiveinvestors.com