Biohope expects to achieve CE marking Self-Certification on June 2019, as the company will accomplish all the needed legal requirements. The TRANSBIO study results (ongoing International Study) will be more than enough to get it by that date. We also have a QA team fully dedicated to the development of the technical file regarding our Kit, which will be produced according to the already in place ISO13485 standard.

Biohope expects to present the IMBG file for FDA approval in 2020.