BARCELONA, Spain, June 24, 2019 /PRNewswire/ -- Transplant Biomedicals, a company specializing in the research and development of medical devices for organ, tissue and cell preservation, announces the positive interim results of the first-in-human clinical trial of VIVIAN® KIDNEY device for transport and preservation.
The EMERGE study enrolled 32 patients who received a kidney from either brain death standard and extended criteria donors (DBD; SCD+ECD) or cardiac arrest donors (DCD MIII). The results show an excellent safety profile with no events related with the device and no organs being discarded. Furthermore, VIVIAN® KIDNEY was associated with a low rate of delayed graft function (DGF) at 30-days with a short duration of DGF and length of hospitalization.
In the primary performance endpoint, the proportion of recipients with DGF was 19%. In the DBD and DCD subgroups, the rate of DGF was 25% and 16%, respectively. No recipient suffered from a graft primary non-function (PNF).
Based on these results, Fritz Diekmann, MD, Head of Renal Transplant Unit at Hospital Clinic de Barcelona and principal investigator of the study commented: "A 19% rate of DGF, is a remarkable achievement, in particular if we take into consideration the high proportion of DCD (61%) and the mean age (over 60-years) of the donor/recipient population included in the EMERGE study. These results are very encouraging for patients undergoing kidney transplantation and surpasses our clinical daily experience and those reported in the literature in comparison to static cold storage."
"These results are in full alignment with our pre-clinical experience and fully support the idea that our disrupting platform that combines hypothermia and low frequency/energy ultrasounds can play a relevant role in addressing the current unmet medical needs not covered by the standard-of-care in solid organ preservation, static cold storage," said Dr. Carmen Peralta, Co-founder and CSO of TRANSPLANT BIOMEDICALS.
"We believe that VIVIAN® is a platform with the profile of a true game changer in organ, tissue and cells preservation market. These interim results in kidney transplantation represent a boost to our mission of improving the outcomes in solid organ transplantation and to continue and accelerate further our development activities in cell and tissue preservation," said Dr. Joan Salgado, CEO of TRANSPLANT BIOMEDICALS.
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SOURCE Transplant Biomedicals