Invenio completes enrollment in 1,006-patient AI lung biopsy study

Invenio Imaging, a San Jose medical-device maker, has completed enrollment in its ON-SITE study of 1,006 patients across seven U.S. medical centers to evaluate its AI-based NIO Lung Cancer Reveal system for assessing lung biopsy tissue during bronchoscopy. The study, which began Dec. 21, 2023, collected more than 3,250 fresh specimens using four biopsy techniques, and the data will support an FDA submission for the device, which uses deep learning to identify suspicious morphology in fresh tissue without conventional staining or sectioning.

Jay Trautman https://www.invenio-imaging.com/team?ref=runtimewire and Chris Freudiger https://www.invenio-imaging.com/team?ref=runtimewire , the founders of Invenio Imaging https://invenio-imaging.com/?ref=runtimewire , have completed patient enrollment in a pivotal U.S. study of an AI system designed to assess lung biopsy tissue while a bronchoscopy is still underway. The San Jose medical-device maker said in its August 3 announcement 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?ref=runtimewire that the ON-SITE study enrolled 1,006 patients at seven medical centers. Thirty-two physicians collected more than 3,250 fresh specimens using four biopsy techniques, giving Invenio the clinical dataset it plans to use for an FDA submission covering NIO Lung Cancer Reveal. The enrollment milestone advances a project that connects Freudiger's work in laser spectroscopy with Trautman's experience commercializing life-science technology. Invenio's team page says Trautman has co-founded five companies, four of which exited, including Vedere Bio, which Novartis acquired for $280 million. He began his career at Bell Labs and later held leadership roles in biotechnology and medical devices. Freudiger was the first author of a 2008 Science paper https://pubmed.ncbi.nlm.nih.gov/19095943/?ref=runtimewire describing stimulated Raman scattering microscopy for high-sensitivity, label-free biomedical imaging. Invenio is turning that laboratory technique into a clinical imaging system that can be operated close to the procedure room rather than inside a conventional pathology workflow. Bringing tissue assessment into the bronchoscopy room Invenio's NIO Imaging System https://www.invenio-imaging.com/technology?ref=runtimewire produces digital images of fresh, unprocessed tissue without freezing, sectioning or staining it. Invenio's company materials describe NIO Slides as a sample-preparation step that existing OR staff can use without staining or sectioning, while allowing the specimen to be retrieved afterward for conventional pathology or molecular testing. That last step matters in lung cancer procedures, where a physician may have limited material to work with. Consuming or damaging a specimen during rapid assessment can leave less tissue available for the biomarker tests that help determine treatment. NIO Lung Cancer Reveal applies a deep-learning model to the resulting images and identifies morphology suspicious for cancer. Invenio is positioning the output as an aid for physicians evaluating whether a bronchoscopic biopsy captured useful tissue. It is not intended to provide the primary diagnosis, and the final clinical decision still depends on pathology and other patient information. The existing workflow alternative is rapid on-site evaluation, commonly called ROSE. That process can give a pulmonologist feedback during a procedure, but it depends on specialized pathology personnel who may not be available in every bronchoscopy suite. Invenio's commercial bet is that imaging hardware and an AI model can place a useful first assessment closer to the physician collecting the sample. The ClinicalTrials.gov record https://clinicaltrials.gov/study/NCT07045103?ref=runtimewire identifies ON-SITE as a multicenter bronchoscopy study combining stimulated Raman histology with AI for rapid lung cancer detection. The research brief says the registry lists the study as starting Dec. 21, 2023, making the August 2026 milestone the result of a multiyear collection effort across institutions and biopsy methods. Enrollment is the start of the regulatory test The announcement establishes the size of the dataset, not how well Lung Cancer Reveal performed. Invenio must now analyze the pivotal validation data. Sensitivity, specificity, false-positive and false-negative rates, and any effect on procedure time will determine whether the system can support the workflow argument Trautman and Freudiger have built around it. The FDA granted Lung Cancer Reveal Breakthrough Device Designation in October 2024 https://www.prnewswire.com/news-releases/invenio-imaging-receives-fda-breakthrough-device-designation-for-ai-based-image-analysis-module-to-assist-physicians-in-the-evaluation-of-bronchoscopic-lung-biopsies-302290901.html?ref=runtimewire . That program can give qualifying devices closer contact with regulators and a faster review process. The designation does not authorize marketing or establish that the device is safe and effective. Lung Cancer Reveal remains investigational in the United States. Invenio has not set out a public timetable for submitting the system or beginning a U.S. commercial launch. Invenio already has one AI product in clinical use outside the U.S. NIO Glioma Reveal is CE-marked for use in Europe and helps neurosurgeons identify areas of cancer infiltration in diffuse glioma cases. In the United States, Invenio lists that product for research use rather than diagnostic procedures. The lung program broadens the founders' original technical thesis beyond brain surgery. Stimulated Raman histology can produce a digital view of untreated tissue quickly enough to affect a live procedure, while AI can help interpret those images where a pathologist is unavailable. ON-SITE gives Invenio a large, multicenter test of whether that combination holds up across physicians, hospitals and several ways of collecting lung tissue. The study also carries federal support. Invenio's announcement says the research is supported by the National Cancer Institute under award 1R44CA281581-01. For Trautman and Freudiger, completing enrollment shifts the burden from building the dataset to proving performance. The next meaningful milestone will come from the validation results and the regulatory case Invenio can construct from them.