Transplant Biomedicals (Barcelona, Spain) said the first-in-human clinical trial of its kidney transportation device has yielded positive results.
The 32-patient study of Vivian Kidney showed an “excellent safety profile” with no device-related adverse events and no organs being discarded before implantation, the company said. The device was also associated with a low rate of delayed graft function (DGF) at 30-days with a short duration of DGF and length of hospitalization. Graft and patient survival will be evaluated at one-year post-transplantation.
Vivian Kidney uses proprietary hypothermic ultrasound preservation technology to combine controlled hypothermia and low frequency/energy ultrasound. The device can activate new intrinsic protective signaling pathways in the preservation of organs, tissue and cells, according to the company.
Transplant Biomedicals is poised to enter an arena that recently saw the stock market debut of TransMedics (NSDQ:TMDX), which has developed an organ transportation system that’s designed to keep donated hearts, lungs and livers in near-living condition until transplantation. In April 2018, TransMedics won pre-market approval from the FDA for its OCS Lung device.
The Vivian Kidney trial is an ongoing multicenter, prospective, open, single-arm study at three hospitals in the Barcelona area: Hospital Clínic de Barcelona, Hospital de la Vall d’Hebron and Hospital de Bellvitge. Serious adverse events were reported in 10 recipients, but were unrelated to the device and are commonly observed in other studies of kidney transplantation and routine clinical practice, according to the company.
“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,” prinicipal investigator Dr. Fritz Diekmann, the head of renal transplant unit at Hospital Clinic de Barcelona, said in a news release.
“These results are in full alignment with our pre-clinical experience and fully support the idea that our disrupting platform 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 chief scientific officer of Transplant Biomedicals.
Company CEO Dr. Joan Salgado called the new device “a true game-changer” in the organ-, tissue- and cell-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,” Salgado said.
Transplant Biomedicals said it is pursuing a total target market of $1.25 billion and is trying to raise nearly $15.5 million to complete the clinical development, final product and market launch.