Partner 9: corlife oHG (corlife)

SME, WP Leader WP3 Processing 

corlife GbR is a small biotechnical enterprise, co-founded in 2006 by Professor Haverich as a spin-off from the MHH, for the development and supply of products and technologies in the fields of cardiovascular and cardiothoracic surgery. Currently employing 12 engineers, biologists and physicians, corlife is specialized in stented and stentless devices based on tissue-engineered matrix composites, which integrate into the patient's body and become indistinguishable from the patient's own tissue. corlife´s proprietary technologies are based on various international patents and patent applications. The company holds the patent for the decullarization processes underlying the production of DHV used in the ESPOIR trial. 

Thus, corlife plays a pivotal role for ESPOIR, as the company will provide all heart valves for the study. Due to the very high demands regarding the quality of samples and legal requirements concerning quality management, corlife is uniquely positioned to be able to produce the implants within the consortium. As sponsor of the clinical trial, corlife is responsible for ensuring adherence to the ICH/GCP-Guidelines to guarantee a safe and effective study. This involves implementing a clinical trial consistent with all European and national regulations, monitoring the clinical trial at all sites (double checking data, analyzing data, and preparing reports) and reporting all events to the authorities. 

Dr. Michael Harder, WP leader for WP3 (Processing) and Exploitation Manager for ESPOIR, avails of over fifteen years experience in leading positions in research, development and production of medicinal products and medical devices and has concluded numerous international cooperation agreements between companies, as well SME as “big pharma”, and universities for the exploitation of technologies. 

Nicolin Heister holds considerable expertise in Regulatory Affairs and Quality Assurance within clinical research organisations. 

Corlife’s expertise is therefore key to the provision of processing and quality assurance of DHV and regulatory affairs for the clinical trial and the project’s exploitation and sustainability strategy. 

Contributors to ESPOIR

Dr. Michael Harder, Managing Director        
Nicolin Heister, Head of Regulatory Affairs