Perimeter Medical Submits FDA Premarket Approval for AI-Enabled OCT System in Breast Cancer Surgery
核心洞察
Perimeter Medical Imaging AI (搜索) has submitted a Premarket Approval application to the FDA for its B-Series OCT (搜索) system with ImgAssist AI 2.0 (搜索) technology for use during breast-conserving surgeries.
The system demonstrated statistically significant reduction in patients with residual cancer during surgery in a pivotal clinical trial involving 206 breast cancer (搜索) patients, potentially lowering reoperation rates.
If approved, the technology could address the current challenge where approximately 1-in-5 breast cancer (搜索) surgeries require repeat procedures due to positive margins, offering surgeons real-time tissue assessment capabilities.
Perimeter Medical Imaging AI (搜索) announced the submission of a Premarket Approval (PMA) application to the U.S. Food and Drug Administration for its next-generation B-Series OCT (搜索) system. The technology combines optical coherence tomography (OCT) with proprietary artificial intelligence to provide real-time tissue assessment during breast-conserving surgeries.
The PMA submission represents a significant milestone for the Toronto and Dallas-based medical technology company, marking its first regulatory approval application for AI-enabled wide-field OCT technology with a specific indication label.
"The ultimate product promise of B-Series OCT (搜索) with ImgAssist AI 2.0 (搜索) is greater peace of mind," said Adrian Mendes, Chief Executive Officer of Perimeter. "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 for up to seven days for their surgeon to receive a post-operative pathology report."
Clinical Evidence Supporting the Application
The PMA submission is supported by positive results from a pivotal clinical trial completed in November 2024. The prospective, multicenter, randomized study enrolled 206 patients with breast cancer (搜索) undergoing lumpectomy for Stage 0-III invasive ductal carcinoma (搜索) and/or ductal carcinoma in situ (搜索).
The trial met its primary endpoint, achieving a statistically significant reduction (p-value = 0.0050) in patients with residual cancer during surgery. The results demonstrated super-superiority of the Perimeter B-Series OCT (搜索) with ImgAssist AI 2.0 (搜索) system compared to current standard methods including palpation, specimen radiograph, intraoperative pathology, and ultrasound.
Technology Behind the Innovation
The B-Series OCT (搜索) system utilizes optical coherence tomography to provide cross-sectional visualization of excised tissues at the cellular level. What sets the technology apart is the integration of ImgAssist AI 2.0 (搜索), a proprietary artificial intelligence tool that enhances the system's diagnostic capabilities.
Andrew Berkeley, co-founder and chief innovation officer at Perimeter, previously explained that ImgAssist AI 2.0 (搜索) "separates each image into a patch, does an analysis on the patch, and gives it a confidence level," enabling more precise identification of concerning tissue areas.
Addressing a Critical Unmet Need
Breast cancer (搜索) surgery outcomes are significantly impacted by the challenge of achieving clear surgical margins. Currently, approximately 20% of breast-conserving surgeries require reoperation due to positive margins discovered during post-operative pathology assessment.
The current standard of care requires patients to wait up to seven days for pathology results to determine if cancer remains at the surgical margins. This waiting period creates significant anxiety for patients, and positive findings necessitate a second surgery with its associated physical, emotional, and financial burdens.
If approved, the B-Series OCT (搜索) with ImgAssist AI 2.0 (搜索) would provide surgeons with real-time assessment capabilities during the initial procedure, potentially reducing the need for reoperations and improving patient outcomes.
Regulatory Pathway and Market Potential
The FDA's PMA review process is the most stringent type of device marketing application required by the agency. While the timeline for review varies, the process typically involves an in-depth evaluation of scientific evidence to ensure the device's safety and effectiveness.
Perimeter's B-Series OCT (搜索) has previously received Breakthrough Device designation from the FDA, which may expedite the review process. The company's development has been supported by a grant of up to US$7.4 million from the Cancer Prevention and Research Institute of Texas (搜索).
"If approved, and based on discussions with physicians, we believe that there is potential for broad adoption of B-Series OCT (搜索) with ImgAssist AI 2.0 (搜索) by breast cancer (搜索) surgeons," Mendes stated in the company's announcement.
Company Background
Perimeter Medical Imaging AI (搜索) is a commercial-stage medical technology company focused on transforming cancer surgery with ultra-high-resolution, real-time imaging tools. The company's FDA-cleared S-Series OCT (搜索) system is already available across the U.S. under a general indication.
The company trades on the TSX Venture Exchange under the symbol "PINK" – a reference to the pink ribbons used during Breast Cancer (搜索) Awareness Month – and on the OTCQX under the symbol "PYNKF."
While the B-Series OCT (搜索) is currently limited to investigational use in the United States, the company's regulatory strategy aims to secure specific approval for use in breast tissue during cancer surgeries to reduce re-excision rates.