Fluoroscopic Pulmonary Visualization System To Aid in Peripheral Lung Nodule Diagnosis

Pulmera, Inc., Redwood City CA

Investigators

Abstract

Project Abstract Bronchoscopic lung biopsy (BLB) is a critical step in the evaluation of suspected lung cancer. BLB is known to be safe and is the preferred method for lung cancer staging. It is unfortunate, however, that obtaining a definitive diagnosis during BLB remains a significant challenge, as evidenced by the poor diagnostic accuracy of 50-70% when compared to alternative biopsy methods (e.g. CT guided biopsy). The low accuracy is a result of the complex lung anatomy and the inability to visualize the dense, tree-like network of peripheral airways in real time. The ideal solution to this problem would be to directly visualize the airways and nodule intraprocedurally, similar to true image-guided procedures that often require navigation (e.g. vascular angiography). At Pulmera, our ultimate goal is to develop an FDA-approved bronchoscopic device platform consisting of a controller unit and catheter, known as PathFinder, that will significantly improve the diagnostic accuracy of peripheral lung nodule and cancer diagnosis. We are developing a patent-pending device and technique to enable real-time digital fluoroscopic x-ray visualization of the bronchial airway tree and target lung nodule. These real-time airway and nodule images, known as bronchograms and nodulograms, respectively, have a similar appearance to angiograms of blood vessels that use iodinated contrast agents. However, the contrast enhancement that we have developed is accomplished without the use of any potentially-harmful substances and is biocompatible. With this SBIR Phase I proposal, we aim to optimize and test the quality and potential clinical usefulness of our bronchograms and nodulograms in pre-clinical in vivo porcine lung models. A successful outcome of this proposal will be detailed device specifications required to produce consistent, high-quality bronchograms and nodulograms, as well as demonstrate early clinical utility. A future SBIR Phase II proposal would focus on engineering a clinical investigational device prototype from these specifications in anticipation of a first-in-human (FIH) study and initial clinical trial. The results of this Phase I proposal and future Phase II studies will be included in our 510(k) application to the FDA for clearance.