Invenio Imaging has completed patient enrolment in its pivotal US ON-SITE clinical study evaluating NIO Lung Cancer Reveal, an investigational artificial intelligence-based image analysis module designed for the rapid assessment of bronchoscopic lung biopsy specimens. The technology works alongside the company's NIO Imaging System, which enables fresh tissue imaging without the need for conventional laboratory preparation.

The study enrolled 1,006 patients, making it one of the largest prospective, multicentre clinical trials conducted in interventional pulmonology. Across seven medical centres, 32 physicians collected more than 3,250 fresh biopsy specimens using multiple bronchoscopic sampling techniques, including transbronchial forceps biopsy, cryobiopsy, transbronchial needle aspiration (TBNA) and Endobronchial Ultrasound-guided Transbronchial Needle Aspiration (EBUS-TBNA).

According to Invenio Imaging, completing enrolment represents a significant milestone in the development of its AI-enabled lung cancer diagnostic platform. The company acknowledged the contributions of patients, investigators, clinical research teams and participating institutions that supported the large-scale clinical effort.

Current bronchoscopic procedures often face challenges in determining whether collected biopsy samples contain sufficient diagnostic tissue during the procedure itself. Although Rapid On-Site Evaluation (ROSE) can provide immediate feedback, its availability remains limited because it requires specialised pathology personnel.

The NIO Imaging System is designed to address this challenge by rapidly imaging fresh, unprocessed biopsy tissue without freezing, sectioning or staining, while preserving the specimen for conventional pathology and molecular testing. NIO Lung Cancer Reveal then applies artificial intelligence to analyse these images and assist physicians in evaluating biopsy quality during bronchoscopy.

Clinical investigators involved in the study noted that as bronchoscopic techniques become increasingly sophisticated, real-time tissue assessment has emerged as a critical unmet need. They believe practical AI-supported assessment within the procedure suite could improve clinical workflows and help physicians make more informed decisions during minimally invasive lung cancer diagnostics.

The ON-SITE trial also demonstrated broad collaboration across participating centres, collecting thousands of specimens using multiple biopsy approaches to validate the performance of the investigational technology in routine clinical practice.

NIO Lung Cancer Reveal has previously received US FDA Breakthrough Device Designation for assisting physicians in evaluating bronchoscopic lung forceps biopsy specimens. However, the AI module remains investigational in the United States and has not yet received regulatory clearance or approval for clinical use.

Invenio Imaging will now analyse data generated from the ON-SITE study to support its planned regulatory submission as it advances the development of AI-enabled diagnostic tools aimed at improving lung cancer detection and patient care.