Organ transplantation has been one of the most significant advances in medicine in the latter half of the 20th century and remains in many cases the only effective therapy for end-stage organ failure. In many cases, transplantation offers definitive treatment for a given disease entity, while in certain conditions is the only meaningful solution for patient survival. Currently, almost 120.000 solid organ transplants are performed each year, with kidney and liver transplants leading the transplant race, representing for almost an 88% of the total procedures globally. However, despite the clinical success of transplantation, it is estimated that only 10% of the global organ needs are covered.
The European Society for Organ Transplantation highlighted several promising approaches to diminish organ shortage taken from the worldwide leader Spanish Model for Organ Donation and Transplantation. The first approach is political and consists in risen the number of potential donors by implementing suitable educational programs. The second approach is clinical and aims at increasing the number of organs viable for transplant by diminishing the number of organ discarded or considered not suitable. It will be achieved by: (A) Considering for transplant organs coming from Expanded Criteria Donors (ECDs hereafter). These organs are discarded because of relative rather than absolute risk factors (45% of organs donated) but are indeed potentially suitable. However, its viability cannot be assessed by any objective mean. (B) Reducing irreversible damages to organs previously considered as viable. These damages are produced during extracorporeal organ preservation after extraction from donor, and are responsible for 10-20% of organs discarded prior to transplantation due to limitations of the organ preservation methods.
The solution proposed by EBERS in the NORMPERF project is introducing a new preservation system (a portable medical device) based on normothermia with predictive capability. Our novel device will be capable of maintaining human organs in a viable state for sustained periods under physiological conditions (hemodynamic conditions) ex-vivo. Such device provides 370C temperature conditions and supplies the organ with oxygen and nutrients in order to resemble the in-vivo conditions, thus maintaining cellular metabolism. Furthermore, our device includes an organ function real-time monitoring system for the continuous assessment of hemodynamic and metabolic performance during preservation and a predictive algorithm to assess organ viability in the form of a viability index before transplantation to the recipient. Thanks to the unique features of our medical device, we will offer two meaningful functionalities:
1) Viability assessment. Accurate organ viability assessment through an index calculated based on clinical parameters.
2) Normothermic perfusion, which perfectly maintains organ metabolism and function
The project final goal is the commercialization of NORMPERF device as a tool for determining accurately organ viability and preserving organs by avoiding irreversible organ damage during extracorporeal preservation. For achieving product commercialization, the project comprises as main objectives:
1) optimization of the current prototype to end up in a fully functional commercial device.
2) obtaining the mandatory CE marking before commercialization.
The successful achievement of these general goals required first to carry out an in-depth feasibility study, covering technical, commercial and financial issues. These were the activities planned for this Phase 1 project, with the final outcome of updating our business plan. The general objectives set for Phase 1 were the following: 1) To eliminate IP infringement risks by means of a freedom to operate (FTO) analysis and to fill in an initial patent application 2) To validate and refine the regulatory strategy based on the additional guidance provided by a notified body, 3) To close the first specifications of the product with final users and customers, validate the market demand estimations and detail the commercialisation plan.
