Development of the Inspired Therapeutics NeoMate Mechanical Circulatory Support System for Neonates and Infants

Project Summary/Abstract Up to 14,000 children in the US are hospitalized with heart failure (HF)-related conditions each year with a mortality rate of 7-15%. Heart transplant is the gold standard of therapy, but the mortality rate while on the waiting list is 5-39%; thus, use of mechanical circulatory support (MCS) devices plays an important role in supporting cardiovascular function in this challenging and heterogenous patient population. MCS options for neonates and infants <10kg are especially limited, as their body habitus renders them too small to receive implantable technology. The objective of this project is to complete development of the Inspired Therapeutics NeoMate system designed to provide up to 30 days of MCS as an extracorporeal left ventricular assist device (LVAD) for neonate and infant HF patients. The NeoMate system is comprised of a compact, miniature centrifugal rotary pump, universal driver (controller with an embedded magnetically levitated (MagLev) motor), and peripheral components (smart battery, touch-screen monitor). Building upon the successful development of the prototype and feasibility testing (completed in SBIR phase I), the next two design iterations will be completed in this SBIR phase II, including computational fluid dynamics (CFD) analyses to predict flow dynamics and hemolysis risk (Aim 1), development of the NeoMate pump (Aim 1), and development of the NeoMate integrated controller and motor with peripherals (Aim 2). The NeoMate system (2nd and 3rd design) iterations will be tested in static and dynamic mock flow loops and acute and chronic ovine models to evaluate hydrodynamic, hemodynamic, and hemocompatibility performance (Aim 3). Data will be used to refine the CFD models and to iteratively improve the engineering design, fabrication, and performance of the NeoMate system. Potential advantages of the NeoMate system include: (1) disposable low-cost pumps for short-term MCS support; (2) reusable MagLev universal controller with integrated motor; (3) the platform technology may support multiple future clinical cardiopulmonary indications for use; (4) smallest diameter impeller (27mm) and compact, integrated, and miniature controller (51mm diameter, 115mm height, 681g weight). Completion of the SBIR Phase II aims will enable Inspired Therapeutics to prepare for a phase IIB study to achieve design freeze of the commercial clinical-grade NeoMate system in compliance with Good Manufacturing Practices, conduct verification and validation testing, and complete the pre-clinical testing in compliance with Good Laboratory Practices. Engineering control documents and experimental data will be used to support regulatory submissions for approval to initiate a phase I clinical trial. The long-term goal of Inspired Therapeutics is to build upon this platform technology to eventually expand the potential markets into cardiopulmonary bypass, respiratory assist, extracorporeal membrane oxygenation, and bi- and right ventricular assistance; however, in this SBIR phase II application, the NeoMate system is being developed and designed for left ventricular assistance and in the underserved neonate and infant HF populations first.