Duluth, Georgia – November 03, 2026 -- Bridge to Life Ltd. has secured a Health Canada Medical Device License for its VitaSmart HOPE System and an FDA Breakthrough Device Designation for investigational use in donor intestines, widening the commercial reach of its organ perfusion platform in North America.
Health Canada license opens liver transplant centers nationwide
The Canadian license covers hypothermic oxygenated perfusion (HOPE) of donor livers and makes VitaSmart available to transplant centers across Canada. More than 4,000 Canadians are on organ transplant waiting lists, and over 100,000 Americans are waiting in the U.S. Bridge to Life executives attended the Canadian Society of Transplantation Annual Scientific Meeting in Montreal in October as part of the market launch.
The company cites its U.S. Bridge to HOPE randomized controlled trial, run across 15 transplant centers with 219 recipients, which showed VitaSmart HOPE improved early allograft function in liver transplantation.
FDA grants Breakthrough status for intestinal perfusion after January De Novo clearance
The FDA designation applies to the system's investigational use in hypothermic oxygenated perfusion of donor intestines. It follows the agency's January 2026 De Novo clearance of VitaSmart for donor livers after static cold storage, within defined DBD and DCD donor criteria.
The Breakthrough Devices Program offers more timely FDA interaction and prioritized review for devices that may treat life-threatening or irreversibly debilitating conditions. The designation is not FDA clearance or approval, and the intestinal application remains investigational.
CEO Don Webber said the company's focus is on "removing friction points" in transplant care, and described VitaSmart as portable, operationally versatile and designed to fit standard clinical workflows.
VitaSmart already runs in Europe, Saudi Arabia and India
Outside North America, VitaSmart is used for both liver and kidney preservation in Europe. It is also available in Saudi Arabia, India and all countries accepting the CE mark.
Bridge to Life is supporting active investigator studies of the system in pancreas preservation. At the 31st International Congress of The Transplantation Society in Sydney, VitaSmart featured in presentations on pediatric multivisceral transplant cases involving all abdominal organs.