#USA #Dallas #Breast Cancer #Perimeter Medical #ImgAssist AI

Groundbreaking Results from B-Series OCT with ImgAssist AI Technology Trial

Recent advancements in breast cancer surgery were highlighted at the 26th Annual Meeting of the American Society of Breast Surgeons (ASBrS), where Perimeter Medical Imaging AI, Inc. presented the results of their pivotal trial involving the innovative B-Series Optical Coherence Tomography (OCT) equipped with ImgAssist AI. This technology aims to enhance intraoperative margin assessment, a critical factor in reducing residual cancer seen in breast cancer surgeries.

Overview of the Trial

Conducted across several clinical sites in the United States, the trial evaluated 206 breast cancer patients undergoing breast-conserving surgery (BCS). The primary aim was to assess the effectiveness of the Perimeter B-Series OCT as compared to current standard-of-care (SOC) methods, which primarily include palpation, specimen radiographs, intraoperative pathology, and ultrasound. The trial's results showed a remarkable reduction in the incidence of residual cancer detected during surgery.

Dr. Alastair Thompson, the trial's primary investigator and a noted professor of surgery, remarked on the pressing nature of intraoperative margin assessment for both clinicians and patients. He emphasized that these trial outcomes could fundamentally alter surgical practices by enabling surgeons to make real-time decisions based on more precise assessments of tumor margins.

Key Findings

The groundbreaking trial achieved its primary endpoint, revealing that among the 206 patients assessed, 17% had residual diseased margins identified after the standard procedure alone. Impressively, incorporating the B-Series OCT led to a 40% additional detection rate of residual disease, allowing for further interventions in patients where previously undetected cancer could have resulted in future complications. This accounted for clearing additional 20% of patients of all residual disease, meeting performance goals with a statistically significant p-value of 0.0050.

The data further demonstrated that the B-Series required less tissue volume to be excised than traditional methods, with only 3.8% of the excised volumes coming from the Perimeter device itself. This not only indicates efficiency but also underscores the minimally invasive nature of the technology, which is aimed at preserving healthy tissue during surgery—a critical consideration for preserving cosmetic outcomes in breast cancer treatment.

Clinical Implications

These promising results signal a potential shift in surgical protocols that could significantly improve patient experiences. By adopting the Perimeter B-Series, surgeons may drastically reduce the need for re-excision surgeries, which not only saves on medical costs but also decreases patient anxiety associated with waiting for pathology results post-operatively. Adrian Mendes, CEO of Perimeter, articulated the ultimate aspiration of enabling a single successful surgery, thereby allowing patients to focus on recovery without the added stress of potential follow-up procedures.

Regulatory Progress

In March 2025, Perimeter submitted a Premarket Approval (PMA) application to the U.S. Food and Drug Administration for the use of the B-Series OCT during breast-conserving surgeries. This represents a significant milestone as it marks the company’s first regulatory submission related to the use of its AI-enabled imaging technology for a specified indication. The submission, which includes pivotal trial results, is currently under review, potentially paving the way for widespread adoption of this advanced technology across surgical oncology practices in the U.S.

Conclusion

The B-Series OCT with ImgAssist AI is poised to transform the landscape of breast cancer surgeries by significantly enhancing the precision of intraoperative assessments. With its promising trial results—showcasing a tailored approach to surgical intervention and patient care—Perimeter Medical Imaging AI stands at the forefront of innovation aimed at combating the challenges posed by breast cancer, ultimately envisioning a future where surgical outcomes lead to quicker recoveries and improved patient quality of life. For further details, visit Perimeter Medical Imaging.