Perimeter Medical Imaging AI (PINK) Status Update summary

Pivotal trial results and clinical impact

• The pivotal trial for the B-Series OCT with ImgAssist AI 2.0 met its primary endpoint, showing a statistically significant reduction in patients with residual cancer during breast-conserving surgery, with a P-value of 0.005 versus a target of 0.025.

• The system demonstrated superiority over standard of care methods, potentially reducing the need for reoperation and providing surgeons with more effective intraoperative margin assessment.

• The trial enrolled 206 patients across multiple U.S. sites, focusing on Stage 0-3 invasive ductal carcinoma and/or ductal carcinoma in situ.

• The technology aims to address the high unmet need in intraoperative margin assessment, which currently leads to repeat surgeries in nearly one in five cases.

Regulatory pathway and next steps

• The FDA has indicated the device will be classified as Class III, requiring a PMA submission, which is expected in early 2025.

• The breakthrough device designation by the FDA allows for accelerated interactions and prioritized review, supporting a faster path to market.

• Preparations for the PMA submission have been ongoing in parallel with the trial, with the company maintaining close communication with the FDA.

• Full trial results, including secondary endpoints, are expected to be presented at conferences and in publications starting in Q2 2025.

Commercial and strategic implications

• FDA approval would enable a full commercial launch in the U.S., with expectations for rapid adoption among breast cancer surgeons.

• The PMA pathway, if successful, could provide market exclusivity and prevent competitors from using the technology as a 510(k) predicate.

• The breakthrough device designation is expected to facilitate future reimbursement discussions and support commercial rollout.