Invenio Imaging Announces Enrollment of First Patient in Pivotal Study of AI-Based Image Analysis

Invenio Imaging Completes Enrollment of First Patient in ON-SITE Study

Milestone in Development of First FDA-Cleared AI for Intraoperative Margin Assessment

SANTA CLARA, Calif., Aug. 9, 2024 /PRNewswire/ -- Invenio Imaging, a leader in intraoperative fresh tissue imaging and artificial intelligence (AI), today announced that it has completed enrollment of the first patient in the ON-SITE study.

The ON-SITE study is a pivotal, prospective, multi-center clinical study designed to evaluate the safety and effectiveness of Invenio Imaging's AI-based image analysis software for intraoperative margin assessment in breast cancer surgery. The study will enroll approximately 300 patients at up to 15 sites in the United States.

"Enrolling the first patient in the ON-SITE study is an important milestone for Invenio as we aim to develop the first FDA-cleared AI for intraoperative margin assessment," said Michael J. Baroni, President and CEO of Invenio Imaging. "We believe our AI-based image analysis software has the potential to significantly improve the accuracy and efficiency of intraoperative margin assessment, which could lead to better outcomes for patients with breast cancer."

Invenio Imaging's AI-based image analysis software uses deep learning algorithms to analyze fresh tissue images taken during surgery. The software is designed to identify and classify cancerous cells, which can help surgeons determine whether a tumor has been completely removed. The software is also designed to provide real-time feedback to surgeons, which could help them make more informed decisions during surgery.