Hybrid Organ GmbH was founded by Prof. J. Gerlach, MD, PhD, as a University spin-off from the Charité, Medical Faculty of the Berlin Universities. R&D included hybrid liver support devices, bioreactors for cell culture, and skin therapy devices.
State and Federal funding including The Innovation Fund from the the Federal German DAB and the Federal State of Berlin, Germany. Incorporation.
1998 – 1999:
Opening of a clean room for bioreactor production, electronic device production, R&D lab, and beginning of prototyping production.
Establishment of a routine production of devices for modular extracorporeal liver support and implementation for a Quality Management System according to ISO 9001 as well as company and production management according to ISO 13485.
2001 – 2004:
Development of the Modular Extracorporeal Liver Support concept (MELS) and a liver support logistic plan. Completing of a successful clinical "EU- Demonstration Project" funded through the European Commission based on the company products. Successful use of bioreactors for German federally funded projects in the development of alternatives to animal experiments in drug development. Completing of a successful state funded project on the development of an autologous skin cell isolation and spray-deposition therapy, with clinical implementation at the Berlin Burn Center.
Certification for CE – ISO through the European Commission (EC) Notified Body TÜV Rheinland. Established an accounting and controlling system according to Datev® requirements (German generic processing system for accounting data) and cost-center accounting with controlling functions and automated project settlement.
Restructuring towards an R&D contracting company under the name StemCell Systems, as Prof. Gerlach accepted new appointments and devoted more time in the U.S. In a strong collaboration with Prof. Gerlach, Prof. Dr. R. Bornemann, MD, PhD, transitioned the team and resources to a new focus on R&D in regenerative medicine. THE company developed an additional area of activities, contracting R&D for industry partners and OEM prototyping of medical devices.
2005 – present:
Activities include contracted biomedical technology R&D and production, stem cell research and regenerative medicine research tools and bioreactors, and skin cell-based therapy product development.