Advancing pediatric ecmo through a biocompatible system design

The National Heart, Lung, and Blood Institute awarded Inflo Medical Inc. $595,332 on September 1, 2026, under the Cardiovascular Diseases Research program (CFDA 93.837) to optimize its MOBYBOX extracorporeal membrane oxygenation (ECMO) platform for pediatric use.

Inflo Medical is redesigning the MOBYBOX's gas exchanger and pulsatile displacement pump to reduce thrombogenicity and hemolysis in pediatric patients. The Phase I Small Business Innovation Research effort focuses on two complementary aims: optimizing the gas exchanger's flow path to enhance hemocompatibility while minimizing priming volume through computational fluid dynamics modeling, and improving overall system design to address the 38 percent complication rate associated with thrombosis in current pediatric ECMO systems. Early studies in animal models and clinical settings have demonstrated marked reduction in thrombus formation in the adult MOBYBOX compared to existing commercial systems.

The award period runs from September 1, 2026, through August 31, 2027. Work is performed in Irvine, California.

Abstract

Inflo medical is revolutionizing pediatric ECMO with a next-generation system engineered to minimize hemolysis and thrombosis, delivering safer, more reliable life support for critically ILL children. Extracorporeal membrane oxygenation (ECMO) therapy is one of the most powerful tools in modern pediatric critical care-often the last resort for children suffering from life-threatening heart and lung failure. However, despite its life-saving potential, current ECMO technology is constrained by outdated designs and high complication rates, particularly in pediatric patients that often present with disturbed coagulation pathways. Thrombosis in the pump and oxygenator components remains a major challenge, contributing to a staggering 38% complication rate in children and limiting broader clinical adoption. As the global burden of critical illness- including conditions like sepsis, which causes 1 in 5 child deaths-continues to rise, there is an urgent need for safer, more accessible ECMO solutions tailored to the unique needs of pediatric patients. To address these urgent gaps, inflo medical will optimize its next-generation ECMO platform, the mobybox, for pediatric use. This compact system incorporates a pulsatile displacement pump, and an advanced gas exchanger, specifically engineered to reduce thrombogenicity and improve gas exchange performance. Early studies in animal models and clinical settings have already shown a marked reduction in thrombus formation for the adult model compared to existing commercial systems. This NIH sbir phase I proposal aims to expand mobybox's capabilities to meet the delicate requirements of pediatric ECMO through two complementary aims: • aim 1: redesign the gas exchanger's flow path to enhance hemocompatibility while minimizing priming volume. Oxygenator geometries will be iteratively optimized using computational fluid dynamics to ensure uniform blood flow and reduced shear stress at low pediatric flow rates. These designs will be validated through benchtop testing and ovine animal models. • aim 2: optimize the displacement pump for pediatric flow conditions and benchmark its performance against traditional centrifugal pumps. Because adverse events like thrombus formation and circuit failure are more likely at low flow rates, this aim will directly evaluate biocompatibility and blood damage metrics, testing the hypothesis that our pulsatile pump reduces shear stress, hemolysis, and clotting risk. By addressing the critical limitations of current ECMO technology, this project has the potential to significantly reduce complications and expand access to life-saving extracorporeal support for tens of thousands of vulnerable children each year. Successful completion will generate key validation data to support future FDA 510(K) clearance and accelerate the path to commercialization for pediatric applications.