SBIR-STTR Award

The broader/commercial impact of this SBIR Phase I project addresses the important unmet clinical need of enabling interventional radiologists to prevent pneumothorax (collapsed lung) during transthoracic lung biopsies. Annually, over 1.2 million transthoracic lung biopsies are performed worldwide for lung cancer diagnosis (400,000 in the US). Pneumothorax (PTX), a collapsed lung, is the most common complication of this procedure, occurring in 20-40% of all transthoracic lung biopsies. More than half of PTX turn symptomatic and require an invasive chest tube insertion, the definitive treatment for PTX. This complication costs, on an average, $15,000 per chest tube insertion and $1.3 billion worldwide to treat. This turns a same-day diagnostic procedure into a costly multi-day hospitalization. The research objectives of the proposed project are to evaluate and demonstrate the feasibility of using a biopolymer sealant and novel access/delivery device to seal needle tracts to prevent PTX during transthoracic lung biopsies. Further, in-vitro and in-vivo preliminary biocompatibility of the material as well as efficacy of the delivery device as compared to the current standard of care will be investigated. This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase II project is to improve patient outcomes, and reduce the morbidity and costs associated with lung collapse (pneumothorax) during computed tomography (CT)-lung biopsies used for screening lung cancer. Over 400,000 CT-guided lung biopsies are performed in the US, and more than 1.2 million worldwide. Management and treatment of symptomatic pneumothorax often requires multi-day hospital stays and costs on average of $15,000 per patient and $1.3 billion yearly worldwide. Preventing pneumothorax may increase access to lung cancer screenings by de-risking CT-guided lung biopsies and allowing smaller ambulatory surgery centers in remote geographies to perform the screening procedure. Currently, physicians collect limited biopsy samples due to the increased risk of pneumothorax with multiple biopsy passes. Preventing pneumothorax may allow physicians to collect a greater number of biopsy samples and provide sufficient tissue to personalize the cancer treatment and improve patient outcomes. This Small Business Innovation Research (SBIR) Phase II project is developing a novel biosealant that will reduce or eliminate pneumothorax. Pneumothorax — a collapsed lung - is the most common complication of computed tomography (CT)-guided lung biopsies, occurring in 20-40% of all CT-guided lung biopsies. The focus of the current investigation is to evaluate and demonstrate the possibility of using a biosealant and delivery device to seal needle tracts to prevent pneumothorax before it occurs, thereby filling a large gap in today’s solutions. Phase I data supports an injectable hydrogel formulation that successfully prevented pneumothorax in animal studies. In this Phase II project, the team seeks to refine the formulation for improved surgical performance and validate it with an animal model to demonstrate both efficacy and safety.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.