Medical technology company Perimeter Medical Imaging AI Inc (TSXV: PINK) (OTC: PYNKF) reported on Tuesday the completion of patient enrolment in a pivotal study assessing the use of its next-generation Perimeter B-Series OCT system.
The system integrates artificial intelligence (AI) technology with optical coherence tomography (OCT) during breast-conserving surgeries (BCS).
If the study is successful, it will demonstrate a reduction in the number of patients where breast cancer was missed during surgery.
This prospective, multi-centre, randomised, double-arm clinical trial enrolled approximately 530 women, aged 18 years and older, undergoing BCS intended for the treatment of Stage 0-III invasive ductal carcinoma and/or ductal carcinoma in situ. Patients were recruited from 10 clinical sites across the United States and randomised in a 2:1 ratio to the device and control arms. Around 200 of these patients will be used to assess the effectiveness of the Perimeter B-Series, which integrates OCT imaging with the ImgAssist 2.0 AI algorithm, in addressing positive margins as compared to the standard lumpectomy procedure.
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