PneumoNIX Medical Inc. SBIR Phase II Award, August 2022

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.