Organ transplantation is in many cases the only effective therapy for end-stage organ failure. However, it is estimated that only 10% of the global organ needs are covered. Traditionally, only organs obtained in optimal conditions have been considered for transplantation. However, organ lack is leading to the increased use of suboptimal grafts (e.g. non-heart beating donors), which poses new challenges. The most important hurdle preventing the clinical use of suboptimal organs is the limitation of static cold storage (SCS). SCS is well suited for optimal grafts, but not for suboptimal ones since (i) it allows short preservation times (2-20 h), (ii) it does not provide information about the organ viability and (iii) it additionally damages the organ due to ischemia-reperfusion.

The solution proposed by EBERS is a new portable medical device based on normothermic perfusion, capable of maintaining human organs in a viable state for sustained periods under physiological conditions. The NORMOPERF project will offer the clinical community a new device for organ preservation that will allow for a x2-3 increase of the current transplant rates, will enable extended preservation times, will improve the clinical results thanks to the use of enhanced preservation conditions and will provide objective real-time information on the quality and function of the organ.

Our technology has already been proven in preclinical tests based on a porcine transplant model. The NORMOPERF project focuses on the industrialization of the technology, on obtaining the regulatory approval as a new medical device and on the execution of a multi-center clinical trial. The work plan is divided in six work packages, as shown in detail below.

 

Work PackageDurationTitle
WP1M1-M12Industrial manufacturing of the commercial version of the product
WP2M6-M22Quality assurance and regulatory
WP3M14-M30Clinical study for validation of the commercial version of the device/consumables
WP4M19-M30Plan for commercial readiness and market access
WP5M1-M30IP, dissemination & communication
WP6M1-M30Operations, financial and technical project management

 

WP1
Industrial manufacturing of the commercial version of the product

The aim of WP1 is to adapt the manufacturing process of the device and its consumables to make it compatible with large scale production and the regulatory requirements in the EU (CE marking) and in a post-project stage in the USA (FDA). The obtained final version of the product will be suitable from a technical, production and regulatory perspective to be employed in subsequent quality & regulatory activities (WP2) and the clinical trial (WP3). The main steps to give in this WP are as follows:

  • Adaptation of the design of the perfusion device for mass production
  • Adaptation of the design of the perfusion circuit (consumable) for mass production
  • Adaptation of the predictive algorithm to the final version of the device
  • Industrialization of the manufacturing process of the final version of the perfusion device and circuit

WP2
Quality assurance and regulatory

The goal of WP2 is to obtain the regulatory approval for our technology as a medical device, which involves (i) managing successfully the achievement of the CE-marking for commercialization of NORMOPERF in EU, and (ii) establishing the strategy for future access to the USA market, including a post-project plan to achieve the FDA approval. The following tasks will be carried out:

  • ISO13485 quality management system implementation
  • Pilot clinical study for verification and validation of the device with human discarded organs
  • Management of the regulatory process in the EU to obtain the CE marking
  • Definition of a plan for post-project FDA approval

WP3
Clinical study for validation of the commercial version of the device/consumables

In WP3 we will demonstrate the efficacy of our device in kidney transplantation procedures. This will be done by means of a multi-center clinical study in kidney transplantation. In this clinical trial the performance of the technology will be evaluated vs. the gold standard method (static cold storage, SCS) by comparing results achieved by using NORMOPERF (experimental group) with results from SCS (control group). This WP will be performed in collaboration with principal investigators (PIs) of seven Spanish transplant centers. Furthermore, the study monitoring will be done by a subcontracted CRO. The following steps will be taken in this WP:

  • Preparation of final clinical trial protocol & regulatory approval
  • Clinical validation study in renal transplantation: follow up & monitoring
  • Statistical analysis of clinical study results and elaboration of medical report

WP4
Plan for commercial readiness and market access

WP4 is devoted to define a precise plan for market access in the EU first and later in the US. Thus, the main objective of this WP is to prepare and implement a market access plan for reimbursement of NORMOPERF technology in the EU countries selected as priority in EU for commercialization in the first selling years. To achieve this goal, we will perform the following tasks:

  • Negotiations with potential clients in EU markets
  • Plan for market access in EU countries
  • Plan for market access in the US

WP5
IP, dissemination & communication

The main goal of WP5 is to provide a wide visibility to the NORMPERF project and our company among the clinical community, key stakeholders and the general public. Moreover, this WP will ensure an efficient and appropriate management of our intellectual property, including the international extension of our IP and competitive intelligence activities.

  • IP management and technology watch
  • Dissemination actions to target the clinical community and other key stakeholders
  • Communication on the internet and social networks

WP6
Operations, financial and technical project management

The overall objective of WP6 is to ensure that all aspects of the NORMOPERF work plan are appropriately managed throughout the duration of the project and all administrative aspects are undertaken and delivered according to EC requirements. More specifically:

  • To ensure all legal, contractual and financial obligations are carried out in an appropriate manner.
  • To ensure that the technical developments of the project are carried out in accordance with the work plan and associated budget in order to achieve the milestones and objectives.