The device has been fully industrialized, becoming a final product that can be fabricated at large scale in compliance with the regulations established for medical devices. The video below shows the basic usage of the device in its final form, after the industrialization process is completed.
The device has obtained the CE mark under the new MDR 2017/745 EU regulation which contemplated only the submission of the technical file to the notified body during the project. As a prerequisite for the CE mark, the company has implemented a quality management system based on ISO 13485 and has been granted the license for manufacturing medical devices by the Spanish Drug and Medical Devices Agency (AEMPS). Furthermore, through a pre-submission process with FDA, the company has better defined the clinical development plan required by FDA to obtain regulatory approval in the US and has modified the clinical study design accordingly. The first pages of the CE mark and the ISO 13485 certificates are shown in the images below.
The clinical development has been addressed during the development of the project:
- A pilot clinical study with human discarded organs was also planned in the project as a validation test and intermediate step before the clinical study. This pilot clinical study has been executed successfully and actually more than 20 organs than originally expected have been recruited. This extension of the scope of the pilot study has been critical for the success of the project.
- A multicentric clinical study is currently ongoing.
The patent portfolio of the company in the field of normothermic perfusion has grown substantially and is now formed by three families of patents that already are or are in the process of being extended internationally.
The results of the project have been disseminated worldwide among customers, investors, patients and publicat large. With this purpose in mind, the new perfusion system has been promoted through various actions such as participation in specialized conferences, conducting training workshops, visits to clinical centers and professionals in the transplant field, presenting the system to associations of transplanted patients, and publishing articles about the system in non-specialized mainstream media. Some picutures of the dissemination activities are shown below.