SAN JOSE, Calif., Aug. 3, 2026 /PRNewswire/ — Invenio Imaging, a leader in fresh tissue imaging and artificial intelligence, announced today the completion of patient enrollment in the ON-SITE study, its U.S. pivotal study evaluating NIO® Lung Cancer Reveal, an AI-based image analysis module for the rapid assessment of bronchoscopic lung biopsy specimens imaged with the NIO® Imaging System.
With 1,006 patients enrolled, ON-SITE is one of the largest prospective, multicenter studies conducted in interventional pulmonology. The study collected more than 3,250 fresh biopsy specimens across seven medical centers, with participation from 32 physicians. Specimens were obtained using transbronchial forceps biopsy, cryobiopsy, transbronchial needle aspiration, and endobronchial ultrasound-guided transbronchial needle aspiration.
“Completing enrollment in ON-SITE is a major milestone for Invenio and for our Lung Cancer Reveal program,” said Jay Trautman, PhD, co-founder and CEO of Invenio Imaging. “We are incredibly grateful to the patients, investigators, clinical research teams, participating institutions, and Invenio colleagues who supported this study. Their dedication and collaboration made a clinical effort of this scale possible and have brought us an important step closer to providing rapid, AI-enabled tissue assessment in the bronchoscopy room.”
Despite major advances in bronchoscopy, determining whether a biopsy contains the tissue needed for diagnosis during a procedure remains a significant challenge. Rapid on-site evaluation (ROSE) can provide immediate feedback but requires specialized pathology personnel and is not consistently available.
“As bronchoscopic procedures become more advanced, our ability to assess the tissue collected during the procedure has not generally kept pace,” said Dr. Gustavo Cumbo-Nacheli, interventional pulmonologist in Grand Rapids and a principal investigator for the ON-SITE study. “There is an urgent clinical need for rapid feedback that can help physicians evaluate tissue in the procedure suite. A practical, in-room approach to tissue assessment could have a meaningful impact on bronchoscopy workflows.”
The NIO® Imaging System rapidly images fresh, unprocessed biopsy tissue without traditional freezing, sectioning, or staining, while preserving the specimen for downstream pathology and molecular analysis. NIO® Lung Cancer Reveal applies artificial intelligence to these images to assist physicians in the evaluation of bronchoscopic lung biopsy specimens.
“The scale of ON-SITE is remarkable and reflects an extraordinary collaborative effort across the participating centers,” said Dr. George Cheng, interventional pulmonologist in San Diego and a principal investigator for the ON-SITE study. “Investigators and research teams worked together to enroll patients and collect thousands of specimens across multiple bronchoscopic biopsy techniques. We are proud to have contributed to a prospective study of this scope and importance.”
NIO® Lung Cancer Reveal received FDA Breakthrough Device Designation for its intended use to assist physicians in the evaluation of bronchoscopic lung forceps biopsies. The NIO® Lung Cancer Reveal detects cell/tissue morphology suspicious for cancer in images acquired with the NIO® Imaging System from fresh/unprocessed biopsy specimens. Its output should not be used as the primary diagnosis and physicians should consider all other clinical factors when making a clinical decision. Invenio will analyze the ON-SITE pivotal validation data in support of its regulatory submission. NIO® Lung Cancer Reveal remains investigational in the United States and has not been cleared or approved for clinical use.
About Invenio Imaging Inc.
Invenio Imaging is an emerging, privately held medical device company based in San Jose, California, dedicated to advancing the care of cancer patients by combining fresh tissue imaging and artificial intelligence. The NIO® Imaging System enables rapid imaging of fresh, unprocessed tissue and has been used across a range of surgical and interventional applications.
Invenio Imaging’s first AI product, NIO® Glioma Reveal, is CE-marked and available for clinical use in Europe. NIO® Lung Cancer Reveal, the AI product evaluated in the ON-SITE study, has not been cleared or approved for clinical use in the United States.
Research reported in this press release is supported by the National Cancer Institute of the National Institutes of Health under Award Number 1R44CA281581-01. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
CONTACT: contact@invenio-imaging.com
View original content to download multimedia:https://www.prnewswire.com/news-releases/invenio-imaging-announces-completion-of-enrollment-in-landmark-study-of-ai-based-image-analysis-for-lung-cancer-302840042.html
SOURCE Invenio Imaging
