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Report

Teaser, summary, work performed and final results

Periodic Reporting for period 1 - NORMOPERF (Normothermic Perfusion Device for Renal and Hepatic Preservation and Viability Assessment)

Teaser

Summary

Organ transplantation is in many cases the only effective therapy for end-stage organ failure. Currently, almost 120.000 solid organ transplants are performed each year, with kidney leading the transplant race representing for almost 66% of the total procedures performed globally. However, despite the success of organ transplantation, this technique is being severely hampered by remarkable constraints. The foremost limitation is the lack of sufficient organs, which is known worldwide as the organ shortage crisis. Official estimations of the WHO confirm that only 10% of the global organ needs for transplant are being covered nowadays. Furthermore, the short preservation time complicates the logistics of the organ transport and gives rise to out-of-hours activity of the medical team and a non-optimal use of the operating rooms. Also, the lack of objective information to assess the viability of an organ just before its implantation makes that potentially viable organs are discarded and, at the same time, that non-viable organs are sometimes implanted. All these constraints not only have negative consequences on the health of the population and the activity of transplant surgeons, but they also involve huge costs to healthcare systems.
These limitations are all related to static cold storage, which is traditionally used to preserve the organ. Instead, EBERS has developed an organ preservation technology based on normothermic preservation, which is not based on slowing down the organ metabolism with low temperatures, but on maintaining the normal metabolic and functional activity of the organ during the preservation outside the body to avoid all the limitations of static cold storage. Thanks to our technology, it is possible to transplant more organs, with better clinical outcome, in safer conditions, with simpler logistics and lower costs.
The specific goals of the project are all related to the latest development stages of our new organ preservation technology and are of three types:
- Technical: industrialization of the process for manufacturing the commercial version of the product at a large scale.
- Clinical: validation of the efficacy of the device in a clinical study.
- Regulatory & Commercial: obtain the CE marking and start negotiations for commercialization with potential customers and distributors.

Work performed

In the first period of the project we have performed the following tasks:
- Redesign of the complete product (device and consumables) to obtain a final commercial version that can be manufactured at a large scale and is aesthetic and usable.
- Industrialization of the manufacturing process of the complete product, including the fabrication of necessary tools (e.g. molds), the selection of critical suppliers, the validation of critical manufacturing processes, etc.
- Implementation of a quality management system based on the ISO 13485 standard. The system is already implanted, has been audited by a notified body (BSI) with positive results and we are about to obtain our ISO 13485 certificate.
- Management of the regulatory process in the EU (CE marking): we have performed all the necessary internal and external assays and elaborated the necessary documentation (technical file) required by the normative; we have been audited by a notified body (BSI). The results of the audit are, in general terms, positive, but two extra assays have been required by the notified body. These assays will be finished in a few weeks, so we expect to obtain the CE mark by the end of the year.
- Start of a pilot clinical with human discarded organs.
- Start of the design of the clinical study.
- Intellectual property: filing of a European patent, currently writing another patent.
- Dissemination of the new technology and the results obtained so far among the clinical community and stakeholders (exhibition in conferences, participation in scientific, medical and investing forums, signature of distribution agreements, contact with the public administration regarding public procurement of innovation programs, etc.).

Final results

Our organ preservation method improves the quality of the organ during the preservation and avoids the ischemic damage caused to the organ by static cold storage, enhancing the post-transplant clinical results. For this same reason, our technique is compatible with suboptimal organs -older or asystolic donors, donors with previous comorbidities, etc.-, which allows increasing significantly the donor pool. Also, the preservation time can go beyond 24 h, which makes simpler the logistics of transplantation. Furthermore, since the organ is working normally while it is connected to our device, it is possible to perform real-time measurements of its function and quality and, thanks to the use of proprietary artificial intelligence algorithms developed by EBERS, estimate its viability. In this way, our technology also becomes a useful clinical decision support system for surgeons. All these positive impacts on the health of patients and activity of transplant surgeons and hospitals will also have a direct impact on the costs of healthcare systems, as we estimate that the use of our device will provide to our clients net savings of 15-30kâ‚¬ per transplant procedure.
By end of the project we expect to have received the CE marking for our device and to have finished the clinical validation study with satisfactory results that support the product launch. From a financial perspective, the launch of this product to the market will involve a huge step forward for the company, as it will be our first medical device product, it will give us access to a new market of huge size and we expect to multiply by x10 our revenues in 3-4 years.