Aerosol Delivery System Therapy for Respiratory Distress Syndrome in Neonates​

Respiratory Distress Syndrome is the most common cause of respiratory distress in premature infants occurring in 24,000 born in the United States annually. It is also the most common complication of prematurity leading to significant morbidity in late preterm neonates and even mortality in very low birth weight infants.​
Develop a non-invasive PFOB (perfluorooctylbromide) delivery system to provide an inhaled medium for neonates at risk of respiratory diseases such as Respiratory Distress Syndrome (RDS) and Bronchopulmonary Dysplasia (BPD) to reduce the incidence and severity of the conditions.​

Battelle leveraged our design engineering and aerosol generation expertise to lead the device design ideation sessions to create initial delivery system concepts and development/implementation of relevant test methods to characterize the output of the PFOB delivery systems.​ Initial preclinical devices were fabricated for use in a series of neonate lamb models with design iterations/updates based on real-time feedback during the study.​ Hazards analyses and risk assessments were performed, and workflow paths developed to provide key input to the assessment.​

Initial development of two delivery systems with further work in progress in preparation for a pre-IND submission to FDA. ​