Invenio Imaging, a leader in fresh tissue imaging and artificial intelligence, announced 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."