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The HepaRG-Bio-Artificial Liver: Feasibility of commercialization and expansion of business plan

Objective

End-stage liver disease patients suffer from a dramatic loss of functional liver tissue, which leads to 50-80% mortality. Liver transplantation is the only effective therapy. However, this life supporting therapy is limited by the shortage of donor livers. As a consequence many patients die while on the transplantation waiting list. The SME Hep-Art has developed a bioartificial liver, the HepaRG-AMC-BAL, that has already shown to increase the survival time in animals with severe liver failure. The HepaRG-AMC-BAL is based on a bioreactor with the human liver cell line HepaRG, which is temporarily connected to the patient's circulation, leading to stabilization and possible recovery of the patient. The system is unique in its functionality and safety. In the BALXPAND project we aim to substantiate the economic perspective of the HepaRG-AMC-BAL. We develop a feasibility plan, including new data obtained in the BALXPAND project: a realistic estimation of production costs, based on a number of pilot runs for cell expansion, a list of large medical device companies for partnering and a list of interested Contract Manufacturing Organisations for GMP-compliant production of HepaRG-AMC-BALs. The resulting updated business plan will be a prerequisite for attracting future corporate partners for phase III trials and commercialisation.

Field of science

  • /medical and health sciences/clinical medicine/transplantation
  • /medical and health sciences/medical biotechnology/tissue engineering/bioartificial liver

Call for proposal

H2020-SMEINST-1-2016-2017
See other projects for this call

Funding Scheme

SME-1 - SME instrument phase 1

Coordinator

HEP-ART MEDICAL DEVICES BV
Address
Meibergdreef 9
1105 AZ Amsterdam Zuidoost
Netherlands
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
EU contribution
€ 50 000