Zaragoza, Spain, September 13th, 2023. Ebers, a company designing pioneering medical devices for ex vivo organ perfusion, has reached a key milestone by obtaining CE mark certification under EU MDR 2017/745. This allows the company to commercialize ARK Kidney® for clinical use in the European market, after launching the solution for research applications in 2021. The new regulatory stamp makes ARK Kidney® one of the first normothermic kidney perfusion products.
“This is a big step for Ebers as it makes ARK Kidney® available to transplant surgeons, nephrologists, and transplant centers in Europe. It also highlights our commitment to quality and regulatory processes, following the highest standards given by the recent MDR EU regulation.” explains Pedro Moreo, CEO of Ebers.
Kidney transplantation stands at a crucial juncture in medical advancement, with approximately 2.5 million individuals worldwide grappling with end-stage kidney disease, a number that continues to rise. This condition places an immense burden on patients, their families, and healthcare systems. Unfortunately, the demand for kidney transplants far exceeds the availability of suitable donor organs, resulting in a challenging and often prolonged waitlist for patients in need. The current transplantation process is further hindered by compatibility issues, the risk of rejection, and the complex logistics of organ transportation. Addressing these critical limitations is paramount, as kidney transplantation represents the best chance of survival and an improved quality of life for those affected by end-stage kidney disease.
To tackle these problems, Ebers created the ARK Kidney®, an innovative perfusion platform that preserves the organ under physiologic conditions —perfused with a blood-like solution, at normal body temperature, with a continuous supply of nutrients and oxygen—with its metabolic and secretory activities unaltered. The aim of the device is to optimize the organ condition by providing the right preservation conditions and to assess the viability of the organ prior to transplantation by measuring its function and metabolism. “The device offers substantial flexibility in terms of the perfusion protocol, as the perfusate composition, hemodynamic conditions, temperature and even urine recirculation are configurable by the user. Furthermore, the inline sensors integrated in the device provide real-time comprehensive data on the organ function.”, points out Víctor Alastrué, CTO of Ebers.
Ebers is at the forefront of organ transplantation research and envisions ex vivo normothermic perfusion of solid organs becoming a routine procedure for organ preservation. “At Ebers we work to develop ex vivo perfusion systems for the transplantation field that improve the quality of life of patients. With ARK Kidney®, we want to deliver each donated organ in the best possible condition for transplantation, by means of mimicking in our device the physiological environment of the organism. This in turn facilitates the task of the surgeon, as it is possible to assess the viability of the kidney by performing measurements while the organ is functioning normally”, concludes the company’s CEO.
ARK is a platform for the perfusion of kidney and liver, which together constitute ~90% of the total number of solid organ transplants globally. A multi-organ version of the device, compatible with kidney and liver normothermic perfusion is already available for the research market and is undergoing regulatory approval as a medical device. A new family of perfusion devices for transplantation is also currently under development.
In the long term, the company has initiated R&D projects to develop pharmacological and advanced therapy treatments to improve the organ condition while preserved in the device.
PROBONEWFOOD. Investigación industrial para la obtención de nuevas fuentes proteicas mediante uso de IA.
Proyecto concedido al amparo del “Programa Misiones de Ciencia e Innovación", del Plan Estatal de Investigación Científica y Técnica y de Innovación 2021-2023, en el marco del Plan de Recuperación, Transformación y Resiliencia – Financiado por la Unión Europea – NextGenerationEU.
Proyecto: “PROBONEWFOOD - INVESTIGACIÓN INDUSTRIAL PARA LA OBTENCIÓN DE NUEVAS FUENTES PROTEICAS ALTERNATIVAS, SOSTENIBLES, NUTRITIVAS Y TRAZABLES A TRAVÉS DE BIOPROCESOS MEDIANTE USO DE IA.”
Fecha concesión: 30 de Diciembre de 2022
Objetivo: PROBONEWFOOD es un proyecto de investigación industrial orientado a generar una base de conocimiento y tecnología aplicables en la búsqueda de nuevos modelos de alimentación humana más sostenibles en el uso de recursos y más respetuosos con el medio ambiente. Este proyecto pretende establecer fundamentos sólidos para la producción industrial de fuentes accesibles de proteínas alternativas, mediante el uso de herramientas biotecnológicas. Además, se monitorizarán las variables claves de los distintos procesos y se aplicarán modelos predictivos basados en inteligencia artificial (Machine Learning – Deep Learning).
Miembros del consorcio:
Proyecto subvencionado por el Centro para el Desarrollo Técnico e Industrial (CDTI), el Ministerio de Ciencia e Innovación, y la Unión Europea.
EBERS received on the 27th of January the outcome of the evaluation of Phase 2 of the Pre-Commercial Procurement Contract for the Development of Innovative Solutions in the Field of Organ Preservation, signed with the Spanish Center for the Technological Development and Innovation (CDTI). The goal of this contract is the design and development of an ex vivo preservation system for solid organs beyond the state of the start, which can contribute to expand the organ donor pool for transplantation and reduce costs of healthcare systems. The works are being executed by EBERS in collaboration with Moses Products, a company specialized in plastic transformation, and Intraven, an SME specialized in the assembly, packaging and sterilization of medical devices.
Phase 2 of the project was devoted to the development of the prototype and the execution of a set of pilot tests. The works in this phase have lasted since the 1st of October of 2021 until the 31st of December of 2022 and have included the fabrication of a prototype of a new normothermic perfusion machine meeting the requirements of the contract and the execution of animal and non-animal tests with it. The evaluation of Phase 2 has been satisfactory and successful, meaning that the project passes to Phase 3, where the prototype will be validated in a pre-operational environment at the facilities of the Minimally Invasive Surgery Centre “Jesús Usón” in Cáceres, Spain.
We summarize below the most relevant aspects of the contract:
Las October 2022, EBERS CTO Víctor Alastrué attended to the VII INTERNATIONAL WORKSHOP ON DCD DONORS which took place la La Coruña (Spain), where the ARK kidney perfusion system was shown and live kidney and liver normothermic perfusions were carried out.