At the start of 2021 Medace welcomes its first German client: TissueGUARD. TissueGUARD provides material innovations for tissue engineering and regenerative medicine applications. The company develops biomaterials for the de novo creation of scaffold-free tissues and organs.
Medace will support TissueGUARD in obtaining CE-certification by setting up an ISO-13485 QMS which complies to the MDR. TissueGUARD projects to be using small scale manufacturing, packaging and warehousing at Medace for their first clinical trials that are planned to start in 2022.
Sarah Tsurkan – Founder: ‘From our first email to our visit of the Medace facilities, we have been pleased with each and every interaction we have had with Medace. We look forward to working together, building a mutually beneficial relationship in order to advance medical device and ATMP developments in Europe.’
The TissueGuard story of the founders Mikhail Tsurkan and Sarah Tsurkan begins at the Leibniz Institute of Polymer Research Dresden (IPF) Germany, where the seeds for the TissueGUARD research initiative were planted. Through a PhD project with the objective to grow corneal cell sheets, the need for a novel biomaterial platform was identified. During this project, all known and established technologies considerably damaged the sensitive artificially produced tissues. Therefore, TissueGUARD team members developed a biocompatible, selectively degradable cell culture platform, which is able to overcome these obstacles – the basis for their innovative technology.