R44HL144214

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 heterogeneous 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.

Inspired Therapeutics

TO FOSTER HEART AND VASCULAR RESEARCH IN THE BASIC, TRANSLATIONAL, CLINICAL AND POPULATION SCIENCES, AND TO FOSTER TRAINING TO BUILD TALENTED YOUNG INVESTIGATORS IN THESE AREAS, FUNDED THROUGH COMPETITIVE RESEARCH TRAINING GRANTS. SMALL BUSINESS INNOVATION RESEARCH (SBIR) PROGRAM: TO STIMULATE TECHNOLOGICAL INNOVATION, USE SMALL BUSINESS TO MEET FEDERAL RESEARCH AND DEVELOPMENT NEEDS, FOSTER AND ENCOURAGE PARTICIPATION IN INNOVATION AND ENTREPRENEURSHIP BY SOCIALLY AND ECONOMICALLY DISADVANTAGED PERSONS, AND INCREASE PRIVATE-SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT FUNDING. SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) PROGRAM: TO STIMULATE TECHNOLOGICAL INNOVATION, FOSTER TECHNOLOGY TRANSFER THROUGH COOPERATIVE R&D BETWEEN SMALL BUSINESSES AND RESEARCH INSTITUTIONS, AND INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL R&D.

93.837 - Cardiovascular Diseases Research

National Heart Lung and Blood Institute (NHLBI) [HHS - NIH]

Saint Paul, Minnesota 551148612 United States

Single Zip Code

PHS 2021-2 Omnibus Solicitation of the NIH, CDC and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed) (PA-21-259)

Amendment Since initial award the End Date has been extended from 06/30/25 to 06/30/26 and the total obligations have increased 505% from $1,002,565 to $6,070,246.