Transplant Biomedicals has reported positive interim results of the first-in-human clinical trial of the Vivian device in kidney transplantation.
For the multi-centre, prospective, single-arm EMERGE trial, the company enrolled a total of 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 trial has been designed to evaluate the safety and performance of the Vivian device for organ preservation in donor kidneys for transplantation.
Transplant Biomedicals completed patient enrolment for the trial in April this year.
The results highlighted an excellent safety profile and no events related with the device were reported.
The device was also associated with a low rate of delayed graft function (DGF) at 30-days with a short duration of DGF.
Transplant Biomedicals co-founder and CSO Dr Carmen Peralta said: “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.”
The proportion of recipients with DGF in the primary performance endpoint was 19%.
In the DBD and DCD subgroups, the rate of DGF was 25% and 16%, respectively.
Transplant Biomedicals CEO Dr Joan Salgado said: “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.”