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.
Taiho Oncology and Taiho Pharmaceutical's INQOVI/venetoclax combination sNDA accepted by US FDA
SciBase introduces Nevisense pilot at Florida research university
Exact Sciences secures Medicare coverage for Oncodetect MRD test in colorectal cancer
Tyra Biosciences to announce TYRA-300 preclinical results at ENDO 2025
Adcentrx Therapeutics' ADRX-0405 granted US FDA orphan drug designation
Avenzo Therapeutics doses first patient in AVZO-1418/DB-1418 Phase 1/2 clinical study
Celltrion USA launches denosumab biosimilars STOBOCLO and OSENVELT (denosumab-bmwo) in US
HotSpot Therapeutics presents small molecule CBM signalosome inhibitor program data
Imfinzi approved in EU as first perioperative immunotherapy for muscle-invasive bladder cancer