Pulmera, Inc. — Department of Health and Human Services SBIR Phase I: 102

Description

Project AbstractBronchoscopic lung biopsyBLBis a critical step in the evaluation of suspected lung cancerBLB is known to be safe and is the preferred method for lung cancer stagingIt is unfortunatehoweverthat obtaining a definitive diagnosis during BLB remains a significant challengeas evidenced by the poor diagnostic accuracy ofwhen compared to alternative biopsy methodse gCT guided biopsyThe low accuracy is a result of the complex lung anatomy and the inability to visualize the densetree like network of peripheral airways in real timeThe ideal solution to this problem would be to directly visualize the airways and nodule intraprocedurallysimilar to true image guided procedures that often require navigatione gvascular angiographyAt Pulmeraour ultimate goal is to develop an FDA approved bronchoscopic device platform consisting of a controller unit and catheterknown as PathFinderthat will significantly improve the diagnostic accuracy of peripheral lung nodule and cancer diagnosisWe 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 noduleThese real time airway and nodule imagesknown as bronchograms and nodulogramsrespectivelyhave a similar appearance to angiograms of blood vessels that use iodinated contrast agentsHoweverthe contrast enhancement that we have developed is accomplished without the use of any potentially harmful substances and is biocompatibleWith this SBIR Phase I proposalwe aim to optimize and test the quality and potential clinical usefulness of our bronchograms and nodulograms in pre clinical in vivo porcine lung modelsA successful outcome of this proposal will be detailed device specifications required to produce consistenthigh quality bronchograms and nodulogramsas well as demonstrate early clinical utilityA future SBIR Phase II proposal would focus on engineering a clinical investigational device prototype from these specifications in anticipation of a first in humanFIHstudy and initial clinical trialThe results of this Phase I proposal and future Phase II studies will be included in ourkapplication to the FDA for clearance Project Narrative Lung cancer is the leading cause of cancer related deaths in the USand one key to improving patient survival is through earlier diagnosis and treatmentWhile bronchoscopy plays an integral role in the early diagnosis and staging of lung cancerwell known limitations exist in its capability to accurately diagnose small peripheral lung nodules and cancersAt Pulmerawe have developed a novel device to enable real timeimage guided bronchoscopic biopsiesraising the bar on lung cancer diagnosis