San Jose, California, August 3, 2026
Invenio Imaging announced the completion of patient enrollment in the ON-SITE pivotal study, a major U.S. clinical study evaluating NIO® Lung Cancer Reveal, an artificial intelligence-based image analysis module designed for rapid assessment of bronchoscopic lung biopsy specimens. The investigational technology combines AI with fresh tissue imaging to assist physicians in evaluating biopsy specimens imaged using the company’s NIO® Imaging System. Completion of enrollment represents an important clinical and regulatory milestone for Invenio as it advances the technology toward a planned U.S. regulatory submission and explores the potential of AI-enabled tissue assessment to improve lung cancer diagnostic workflows.
ON-SITE Pivotal Study Enrolls More Than 1,000 Patients
The prospective, multicenter ON-SITE study enrolled 1,006 patients across seven U.S. medical centers, making it one of the largest prospective multicenter studies conducted in interventional pulmonology, according to Invenio. The study involved 32 physicians and collected more than 3,250 fresh biopsy specimens using four different bronchoscopic biopsy techniques. These included transbronchial forceps biopsy, cryobiopsy, transbronchial needle aspiration and endobronchial ultrasound-guided transbronchial needle aspiration. The scale of the study is designed to provide a substantial clinical dataset for evaluating the performance of NIO® Lung Cancer Reveal across multiple biopsy approaches and clinical settings. Invenio will now analyze the pivotal validation data generated through ON-SITE to support its planned regulatory submission. The study addresses an important challenge in bronchoscopy: determining during a procedure whether collected biopsy specimens contain the tissue required for diagnosis. Although rapid on-site evaluation can provide immediate feedback, this approach requires specialized pathology personnel and may not be consistently available across healthcare facilities.
AI Technology Enables Rapid Fresh Tissue Assessment
The NIO® Imaging System rapidly images fresh, unprocessed biopsy tissue without requiring conventional freezing, sectioning or staining. Importantly, the process preserves specimens so they remain available for subsequent pathology and molecular analysis. NIO® Lung Cancer Reveal applies artificial intelligence to images generated by the NIO Imaging System to assist physicians with evaluation of bronchoscopic lung biopsy specimens. The technology detects cell and tissue morphology considered suspicious for cancer in images of fresh, unprocessed biopsy samples. Invenio is developing the system to provide physicians with rapid feedback in the bronchoscopy procedure suite, potentially addressing the gap between advances in bronchoscopic tissue acquisition and immediate assessment of the material collected. However, the AI system is designed as an assistive technology rather than a replacement for standard diagnostic processes. Its output should not be used as the primary diagnosis, and physicians are expected to consider other relevant clinical information when making patient-care decisions.
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FDA Breakthrough Device Advances Toward Regulatory Submission
NIO® Lung Cancer Reveal has received FDA Breakthrough Device Designation for its intended use in assisting physicians with evaluation of bronchoscopic lung forceps biopsies. Completion of the ON-SITE enrollment therefore represents an important step in generating the pivotal clinical evidence needed for Invenio’s regulatory strategy. The company plans to analyze the study’s validation data in support of a future regulatory submission. NIO® Lung Cancer Reveal remains investigational in the United States and has not received FDA clearance or approval for clinical use. Invenio Imaging is a privately held medical device company focused on combining fresh tissue imaging and artificial intelligence to advance cancer care. Its NIO Imaging System has been used across surgical and interventional applications, while the company’s first AI product, NIO® Glioma Reveal, is CE-marked and available for clinical use in Europe. The ON-SITE study was supported by the National Cancer Institute of the National Institutes of Health. With enrollment now complete, analysis of the pivotal study will be critical in determining the clinical performance of NIO Lung Cancer Reveal and supporting the company’s efforts to advance AI-assisted lung cancer tissue assessment toward potential U.S. clinical use.
Source: Invenio Imaging press release
