Paragonix Heart Sherpa for Extended Preservation of Donor Hearts

DESCRIPTION (provided by applicant): Organ preservation and safe transport is a critical factor in transplantation medicine, but adequate preservation of human organs donated for transplantation poses a significant challenge. While significant progress hasbeen made in defining the principles governing tissue preservation and storage prolongation, development of a technology in a configuration that is simple to use, highly portable and cost effective remains. The objective of this proposal is the development of a single-use, low-cost and highly portable heart preservation system that enhances organ quality, extends preservation times and provides for safe transport of hearts for transplantation. The principles are based on hypothermic machine perfusion (HMP). The technology is unique in that our device departs from currently accepted electro-mechanical concepts of perfusion (which necessitate pumps, motors, and batteries). The underlying technology instead relies on elasto-mechanical properties of the organ compartment in combination with control elements in order to harness the energy stored in compressed oxygen. This energy drives perfusion of the organ, simultaneously oxygenating the perfusate. Recoil of the organ compartment returns the perfusate for CO2 removal and re-oxygenation. Our proposed product addresses three main components that make HMP a superior preservation technique compared to static cold storage. First, using HMP, waste product removal and blood washout are achieved by prolonged perfusion.Second, oxygen is supplied to the organ to support the level of metabolism at hypothermia. Third, low pressures are used for perfusion, minimizing the potential for endothelial damage. The system is based on proven scientific principles that can be used to 1) improve the quality of transplanted hearts and thereby patient outcomes, 2) reduce transplant-related healthcare costs, 3) expand the donor pool in order to increase the number of available organs, and 4) extend the time window between organ recoveryand transplantation into the recipient. The Specific Aims for this Phase I SBIR grant is to design and engineer a fully functional commercial prototype of a highly portable, single-use, low cost heart perfusion, preservation and transport system. The benchmark of completion of Phase I is 1) a full description (text, sketch, sketch-CAD) of the prototype and the production of a fully functional prototype that perfuses heart for 12 hours at a constant temperature of 4 C and 2) evaluating safety and efficacy of this heart preservation device by assessment of 12-hour perfused swine hearts. These studies will provide data from pre-clinical studies required for FDA approvals as well as set the stage for follow-on human clinical trials. PUBLIC HEALTH RELEVANCE: There is a 5x greater demand for transplant organs than there are available donors. Organ preservation and safe transport is a critical factor in transplantation medicine, but adequate preservation of human organs donated for transplantation posesa significant challenge. In order to make more organs available and to increase organ quality, the objective is to produce and test a commercial pre-production prototype of a highly portable, single-use, low cost heart perfusion, preservation and transport system. The overall goal is to develop, validate and commercialize a heart preservation device for the extended preservation and transportation of donor hearts.