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Report

Teaser, summary, work performed and final results

Periodic Reporting for period 1 - NORMOPERF (Normothermic perfusion devices for renal and hepatic preservation and viability assessment)

Teaser

Summary

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

Work performed

During this Phase 1 project we performed an assessment of the feasibility of our business innovation project from different perspectives: commercial, technical/scientific and financial.
From a technical point of view at this point we have already verified the product/market fit of the technology. We have analysed the NORMPERF product concept, its impact in organ viability and the benefits for the healthcare system arising from the implantation of our technology. We have also analysed the market we plan to entre, its segmentation and how our technology is aligned with the key market drivers. Furthermore, we have also identified potential market barriers and more important, we have defined the best strategy to overcome these barriers by defining specific measures. One of the most important goals achieved is that we verified the buying drivers of NORMPERF technology performing a survey among renowned surgeons that will be part of the Scientific Advisory Broad we created for the Phase 2 project. Some of the doctors participating in the survey will also participate in the clinical study we plan to perform for Phase 2 with regard to advance in the clinical validation of our technology. Furthermore, we already count with the feedback of five key decision makers (responsible in healthcare expenditures) within the Spanish healthcare system (worldwide leader in transplantation field).
Furthermore, we can confirm that we have sound and feasible IP and regulatory strategies by: 1) performing a FTO that confirms that no infringement issues are present 2) we are currently elaborating the report for filling a patent application to gain IP protection for our technology in all targeted markets. Through the advances reached by selecting the notified body and after receiving the feedback of the elaborated Clinical Evaluation Report we have a clear strategy for the CE-marking obtaining, which will be achieved during Phase 2 project execution.
Regarding to set a consistent commercialization plan, we have considered: (1) project objectives and their corresponding milestones (2) the acquired market knowledge including the market study performed and priority markets found (3) the regulatory path. This knowledge, together with the support of the survey conducted, allowed us to set the basis for a robust commercializationl plan.
From a financial point of view, we have projected the 5 yearsâ€™ NORMPERF profitability for different scenarios concluding that the project is highly profitable. In the most pessimistic scenario, the beak even is reached in the third selling year and the R.O.I (return of investment) is 273%. The most optimistic case reaches the ROI up to 459%. The base case, as the one we consider the most realistic and the base of our 5 years business plan, reaches the break even in second year of commercialization and provides a R.O.I of 366%. This means that for each euro invested in the project it seems completely realistic to achieve a profitability of 3.7â‚¬ in 5 yearsâ€™ commercialization, a clear evidence on the NORMPERF project profitability.
In summary, the most important conclusion of this Phase 1 project is that the NORMPERF project proposes a complete feasibility concept and a demonstrated profitability. Thus, now that the possibility of applying for phase 2 has been evaluated we can confirm that our technology will be technically viable and that there is a strong market demand as reflected in the survey conducted and the market study. In summary, both technical and commercial issues enable us to applying for Phase 2 in the next cut-Off.

Final results

The viability assessment capability and the Normothermic perfusion are two distinctive features achieved by the development of NORMPERF technology, which prevent the limitations and barriers of conventional tools currently available. Hence, the implementation of NORMPERF technology in the clinical practice will increase the organs available for transplant as the number of organs discarded will diminish. First by supporting the clinician decision. The viability index calculated is based on the accurate measurement of clinical parameters rather than potential risk factors of the donor profile. Thus, it allows to increase donor profile as potential donors by including for evaluation those donors fit into the ECDS category, since the relative contraindications will not be considered as exclusion parameters. This technology feature of NORMPERF has the potential to extend the number of organs available by considering viable a significant proportion of the 45% organs currently discarded by relative risk factors. Second, by preserving the organs in similar metabolic and physiological conditions as are in the body, and thus it will be totally avoided the damage caused by cooling. Hence, the number of organs that will not be damaged and therefore could be transplanted will increased by 10-20%.
The implementation of NORMPERF in the healthcare system will benefit all players within the transplant process. These benefits involve significant cost reductions per transplantation process that range from 18.400â‚¬ to 27.600â‚¬ depending on the organ type for the hospitals -our customers- demonstrating the high cost-effectiveness. For instance, the increased number of transplanted organs implies cost savings simply by reducing the use of alternative treatments, like renal dialysis in the case of kidney transplant (average monthly savings of â‚¬3.800 per patient). Furthermore, the improved clinical results also have a direct translation into quantifiable savings (shorter ICU time, hospital stays, simpler outpatient follow-up, etc.). Finally, extended preservation times improves transplant logistic by eliminating the need of urgent transportation methods, allow transforming emergency surgeries into programmed procedures and cut costs of out-of-hours activity.