Perimeter Completes Patient Enrollment in Pivotal Breast Cancer Trial
Tuesday, Oct 1, 2024 4:20 pm ET
1min read Perimeter Medical Imaging AI, Inc. (TSXV: PINK) (OTC: PYNKF) (FSE: 4PC) has announced the completion of patient enrollment in its pivotal clinical trial evaluating the Perimeter B-Series OCT with ImgAssist AI in breast-conserving surgeries. This significant milestone paves the way for interim analysis and final results, which are expected to support the commercialization of the next-generation AI technology.
The randomized, controlled trial aims to assess the impact of Perimeter B-Series OCT with ImgAssist AI on re-operation rates for patients undergoing breast conservation surgery. The primary endpoint is the reduction in re-excision rates, while secondary endpoints include the assessment of the technology's impact on surgical margins, specimen imaging, and overall patient outcomes.
Following the completion of patient enrollment, Perimeter will proceed with the interim analysis, which is expected to provide valuable insights into the trial's progress and potential outcomes. The interim analysis will help refine the study's design and ensure that it remains on track to meet its primary and secondary endpoints.
The regulatory process following the completion of patient enrollment will involve submitting the final data to the U.S. Food and Drug Administration (FDA) for review. The FDA will evaluate the trial's results and determine whether the Perimeter B-Series OCT with ImgAssist AI meets the required safety and efficacy standards for commercialization.
The enrollment milestone has a significant impact on Perimeter's financial projections and potential market entry for the B-Series OCT with ImgAssist AI. The company expects to generate revenue from the commercialization of this next-generation technology, which could expand its market reach and strengthen its position in the medical technology sector.
In conclusion, the completion of patient enrollment in Perimeter's pivotal clinical trial marks a crucial step towards the commercialization of its next-generation AI technology in breast-conserving surgeries. The interim analysis and final results will provide valuable insights into the technology's potential impact on patient outcomes and re-operation rates. As the regulatory process progresses, Perimeter is poised to expand its market reach and generate revenue from the commercialization of the B-Series OCT with ImgAssist AI.
The randomized, controlled trial aims to assess the impact of Perimeter B-Series OCT with ImgAssist AI on re-operation rates for patients undergoing breast conservation surgery. The primary endpoint is the reduction in re-excision rates, while secondary endpoints include the assessment of the technology's impact on surgical margins, specimen imaging, and overall patient outcomes.
Following the completion of patient enrollment, Perimeter will proceed with the interim analysis, which is expected to provide valuable insights into the trial's progress and potential outcomes. The interim analysis will help refine the study's design and ensure that it remains on track to meet its primary and secondary endpoints.
The regulatory process following the completion of patient enrollment will involve submitting the final data to the U.S. Food and Drug Administration (FDA) for review. The FDA will evaluate the trial's results and determine whether the Perimeter B-Series OCT with ImgAssist AI meets the required safety and efficacy standards for commercialization.
The enrollment milestone has a significant impact on Perimeter's financial projections and potential market entry for the B-Series OCT with ImgAssist AI. The company expects to generate revenue from the commercialization of this next-generation technology, which could expand its market reach and strengthen its position in the medical technology sector.
In conclusion, the completion of patient enrollment in Perimeter's pivotal clinical trial marks a crucial step towards the commercialization of its next-generation AI technology in breast-conserving surgeries. The interim analysis and final results will provide valuable insights into the technology's potential impact on patient outcomes and re-operation rates. As the regulatory process progresses, Perimeter is poised to expand its market reach and generate revenue from the commercialization of the B-Series OCT with ImgAssist AI.