About corlife
Vision
Corlife has committed itself to improving the quality of life of people undergoing heart or central blood vessel surgery. We develop innovative and safe products for this purpose. We are aware of our responsibility towards patients, tissue donors, cooperation partners, physicians and employees. Safety, quality and empathy determine our actions.
History
Discover more about the history of corlife in this slideshow.
1996: The Nineties
Physico-chemically conditioned bone and tendon transplants have been used successfully in patients for quite some time. The transplants are largely cell-free and sterile and are therefore safe and well tolerated. Axel Haverich, Head of Cardiothoracic, Thoracic, Transplantation & Vascular Surgery, founded the Leibniz Research Laboratories for Biotechnology and Artificial Organs LEBAO in Hannover in 1996. There, these technologies are applied to blood vessels and heart valves for decellularization. After innumerable in-vitro experiments, a few methods that appear to be safe can be verified in animal models. The researchers are in competition with working groups in Germany, Brazil and the USA.
2006: Foundation
Corlife is founded for the "development, production and distribution of pharmaceutical products and medical devices". From the beginning, the company is financed and managed exclusively by the founders (Axel Haverich, Clemens Meyer-Kobbe, Michael Harder).
2008
Photo: © Ansgar Pudenz/German Future Prize
Axel Haverich and Michael Harder, as well as the Moldavian-born physician Serghei Cebotari, are nominated for the German Future Prize. The nomination for this recognized innovation prize meets with resistance from a competitor and the press. In essence, the nominees are accused of not pursuing an independent and innovative strategy and of disregarding essential ethical standards. The nomination is revoked. The ethical accusations prove to be groundless. The patent opposition proceedings are concluded to the advantage of corlife.
2011: New clean rooms
Photo: Karin Kaiser/MHH
Corlife and the Hannover Medical School (MHH) started up new cleanrooms for the production of innovative implants on 16.05.2011. The project was funded by the State of Lower Saxony and the European Commission. Prof. Dr. Johanna Wanka, Lower Saxony's Minister for Science and Culture, inaugurated the rooms together with Prof. Dr. Axel Haverich, Director of the Clinic for Cardiac, Thoracic, Transplant and Vascular Surgery, Prof. Dr. Christopher Baum, Dean of Research at the MHH, Dr. Michael Harder, Managing Director of corlife and Dr. Andreas Tecklenburg, Vice President of the MHH (from left to right).
2012: European clinical study on the use of regenerative heart valves (ESPOIR)
Photo: K. Fuchs, Medizinische Hochschule Hannover
The aim of ESPOIR is to assess the safety and tolerability of cell-free pulmonary valves in clinical application. Leading collection facilities and clinics in Brussels, Chisinau, Hannover, Leiden, Leuven, London, Padua, Vienna, Zurich and corlife are involved. The consortium is accompanied by an independent Ethics and Governance Council. ESPOIR is awarded the ENCePP Study Quality Seal for maintaining high standards based on the principles of scientific independence, transparency, and robust methodologies (PAS28980). ESPOIR was successfully completed in 2016. The results are available to the public. ESPOIR was supported by the "Seventh Framework Programme of the European Community for Research, Technological Development and Demonstration Activities" with the grant number 278453.
2013: Approval
On 29.08.2013, after 17 years of tireless research and development, the Paul-Ehrlich-Institut approves the "Cell-free human pulmonary valve, Espoir PV" as a medicinal product.
2015: ARISE
The Paul-Ehrlich-Institut approves the "Cell-free human aortic valve, Arise AV" as a medicinal product. In the same year the European observational study ARISE starts in Austria, Belgium, Germany, Italy, Netherlands, Spain, Switzerland and the United Kingdom, funded by the HORIZON 2020 Program of the European Union (#643597). The study results children and adults will be published in 2020.
2019: 500
Foto: Marco Lux
Corlife delivers the 500th cell-free heart valve to the university hospital in Erlangen.
2023: 1000
Corlife celebrates the 1000th delivery of cell-free cardiovascular tissues. Our employee Marco Lux is holding the 1000th package in his hands in the photo. We are looking forward to the next 1000 deliveries.
Team
Discover more about the corlife Team in this slideshow.
CEO – Dr. Michael Harder
corlife is an innovative and reliable partner for cooperation partners and clinicians, a fair employer for employees and a sustainable company for society.
I have been working as a biologist in research and industry for over 30 years and have managed corlife since it was founded in 2006. The development, manufacture and distribution of innovative cardiovascular implants present us with new ethical, technical and regulatory challenges every day. My job is to set the necessary course in good time and mobilize sufficient resources to meet these challenges.
Operations – Dr. Bianca Lindner
Quality does not just start with the product. Rather, it is lived in all processes in the company and is constantly evolving. I transform this claim into lived processes.
As a chemist, I worked in biotechnological research for several years and have also worked as a quality management officer and auditor. In my role as Head of Operations, I design processes and am responsible for ensuring that they run smoothly and safely in a technically demanding pharmaceutical environment.
Tissue Services - Dr. Marco Lux (Responsible person §§ 20b, 20c AMG)
Gewebespenden sind ein kostbares und seltenes Gut. Jede Gewebespende, die wir zu treuen Händen erhalten, verdient große Aufmerksamkeit und Sorgfalt. Mein Ziel ist es aus diesen Spenden besser verträgliche, zellfreie Allografts herzustellen und deren Qualität stetig zu verbessern.
My biological education began with the study of "Molecular Life Science" at the University of Lübeck. During this phase I developed a strong interest in tissue engineering, which I deepened during my doctorate at the Medical University of Hannover.
I have been head of the “Tissue Services” department at corlife since 2015. This organizational unit processes human allografts - in particular cell-free pulmonary and aortic valves - and releases them for use in humans.
Compliance – Nicolin Heister, Regulatory Affairs
My goal is to guarantee drug safety and ensure the greatest possible transparency vis-à-vis authorities, users and patients.
I have been working for corlife as a biologist since 2009. I am the contact person for all questions regarding approvals and vigilance vis-à-vis authorities and users. In addition, I organize and support information events for patient organizations.
My responsibilities include the planning, execution and monitoring of studies in which our cell-free allografts are followed up. The findings from studies are the basis for measures to improve safety.
Quality Management – Dr. Carmen Puschmann
Quality is practiced and continuously improved in all our processes within the company. Looking at the principles and interrelationships of our QMS as a whole and finding the right balance is very important to me.
I have a degree in biology. I have been in charge of quality management since 2024 and ensure that all company processes comply with legal requirements and the ISO 9001 standard. The job involves many internal and external audits so that potential for improvement can be identified at an early stage.
Quality assurance - Dr. Bettina Giere
A holistic view of the processes is important to me in order to guarantee a consistently high standard of quality.
After studying veterinary medicine and several years of research, I joined the company in 2006 and have been involved in many development processes in the field of tissue processing. Initially responsible for quality control, I have been in charge of quality assurance since 2024. It is a central element of quality prevention, monitoring and control of process risks. Critical control points are defined and their effectiveness is regularly reviewed. The planning and continuous evaluation of all process-relevant validations are an important part of this. Translated with www.DeepL.com/Translator (free version)
Quality control - Dr. Ralf Haller (Responsible person §§ 20b, 20c AMG)
Quality control is an essential part of processing and requires special attention in order to ensure sufficient quality and safety for patients.
After studying “Molecular Life Science” at the University of Lübeck, I completed my doctorate in cell biology at the Hannover Medical School.
I have been working at corlife since 2018. Initially responsible for research and development, I have been in charge of quality control since 2024 and am responsible for ensuring the quality of tissue preparations. This area of responsibility ranges from the selection of materials and services to regular environmental monitoring and process and tissue monitoring.
Corporal recovery and contact person for recovery facilities - Loretta Belfiore
The opportunity to contribute my experience from my autopsy work in the field of tissue donation is a valuable opportunity. It is particularly important to me to treat donors with the utmost dignity. My goal is to contribute to better meeting the high demand for compatible allografts.
As a trained medical dissection and preparation assistant, I have already come into contact with the topic of organ and tissue transplantation in the past and have been working at corlife since 2022. My responsibilities include communicating with cooperating recovery facilities, as well as training and auditing them. I also coordinate the supply of transport materials and provide support with specific issues relating to corporeal procurement and tissue assessment.
Receiving and extracorporeal recovery of tissues - Dr. Lena Pogozhykh
Die Entgegennahmeprüfung ist die erste von vielen Qualitätsprüfungen bei corlife. Ich stelle sicher, dass nur für die Implantation geeignete Gewebe für die weitere Bearbeitung angenommen werden.
After studying genetics and cytology in Kharkiv, Ukraine, I completed my doctorate in the field of cryobiology and continued my research on stem cells and human tissue at the Hannover Medical School. I have been working at corlife since 2022. I am responsible for the receipt, preparation and assessment of allografts during the incoming inspection.
Data management and allocation - Corinna Brandt
The fair allocation and reliable delivery of cell-free allografts to our customers is very important to me.
After completing my Master's degree in Life Science in 2022, I started my career at corlife in the same year. Since 2024, I have been responsible for data management and the allocation of cell-free allografts and coordinate their transportation to the clinics.
Data management brings together and evaluates all information on tissue donations and cell-free allografts so that the findings can support process optimization.
Culture
Work of heart.
We have different professional backgrounds and cover a wide age range. We are united by our desire and ability to develop and deliver good, safe and sustainable products for patients.
We are looking forward to new team players who enrich us with their knowledge and commitment and who are looking forward to helping us shape the future.
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