Bridge to Life™ Expands North American Commercial Footprint with Regulatory Milestones in the U.S. and Canada

• Health Canada Medical Device License makes VitaSmart® available to transplant centers across Canada
• U.S. FDA grants Breakthrough Device Designation for the use of the VitaSmart® System for investigational hypothermic oxygenated perfusion of donor intestines

DULUTH, Ga., Nov. 3, 2026 /PRNewswire/ -- Bridge to Life™ Ltd., a global innovator in organ preservation solutions and perfusion technologies, today announced two regulatory milestones that expand the company's addressable market and build momentum for its VitaSmart® platform. Health Canada has issued a Medical Device License for the VitaSmart® Hypothermic Oxygenated Perfusion (HOPE) System for hypothermic oxygenated perfusion of donor livers, making the system available to transplant centers across Canada, while the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the system's investigational use in hypothermic oxygenated perfusion of donor intestines.

More than 4,000 Canadians and over 100,000 Americans are currently on waiting lists to receive life-saving organ transplants, and the shortage of transplantable organs remains one of the greatest constraints in transplant care. VitaSmart® is designed to help transplant teams address this gap by mitigating ischemic injury and supporting confident use of more donor livers. In the U.S. Bridge to HOPE randomized controlled trial, conducted across 15 transplant centers with 219 recipients, VitaSmart® HOPE improved early allograft function in liver transplantation. These milestones strengthen Bridge to Life's position as it converts pipeline innovation into commercial opportunities with scalable adoption.

"Securing our Canadian market authorization alongside FDA Breakthrough Device Designation continues to accelerate momentum in our global commercial trajectory," said Don Webber, President and Chief Executive Officer of Bridge to Life™. "Our vision has always focused on removing friction points within the transplant care ecosystem. VitaSmart® is engineered to be portable, operationally versatile, and seamless to embed into standard clinical workflows. By giving surgical teams better preservation options, we aim to help them use more of the organs available to them, improve outcomes for recipients, and save more lives."

Opportunity to save more lives with Canadian authorization

With Health Canada authorization secured, the company is set to introduce VitaSmart® to liver transplant surgeons and care teams across Canada. This achievement underscores a commitment to working alongside North American healthcare professionals to deliver technologies tailored to modern transplantation needs, advancing organ preservation standards and improving outcomes for transplant recipients. As part of this Canadian market launch, Bridge to Life™ leaders attended the Canadian Society of Transplantation (CST) Annual Scientific Meeting in Montreal, QC, in October.

FDA Breakthrough Device Designation in the U.S.

Following the FDA's January 2026 De Novo clearance of the VitaSmart® System for hypothermic oxygenated perfusion of donor livers after static cold storage, within defined DBD and DCD donor criteria, the FDA has now granted Breakthrough Device Designation for the system's investigational use in the hypothermic oxygenated perfusion of donor intestines. The Breakthrough Devices Program is intended to provide more timely FDA interaction and prioritized review for devices that may offer more effective treatment of life-threatening or irreversibly debilitating conditions. Breakthrough Device Designation does not constitute FDA clearance or approval, and the intestinal application remains investigational.

The designation is a meaningful milestone for the platform in intestinal transplantation, a field with significant unmet need given the intestine's sensitivity to ischemic injury. It also builds upon Bridge to Life's broader strategy to establish VitaSmart® as a versatile, multi-organ platform. Beyond North America, VitaSmart® is already used for both liver and kidney preservation in Europe. It is also available in Saudi Arabia, India, and in all countries accepting the CE mark.

Bridge to Life™ is also supporting active investigator studies evaluating the system's efficacy in pancreas preservation. VitaSmart® was recently highlighted in Sydney during the 31^st International Congress of The Transplantation Society, which featured presentations on successful pediatric multivisceral transplant cases involving all abdominal organs.

About Bridge to Life™ Ltd.

Bridge to Life™ Ltd. is a global innovator in organ preservation and perfusion technology. Driven by a commitment to science-based innovation, the company empowers transplant teams with advanced tools that help expand the donor pool, streamline clinical workflows, and improve patient outcomes worldwide. VitaSmart® joins a preservation franchise anchored by Belzer UW®, one of the most widely used preservation solutions in abdominal organ transplantation. Together, the portfolio gives Bridge to Life™ a differentiated position spanning both established preservation and next-generation machine perfusion.

Product Development Statement

Pipeline programs described in this release, including applications for intestinal perfusion, are investigational, and are not cleared or approved by the U.S. Food and Drug Administration or any other regulatory authority. Nothing herein should be construed as a claim of safety or effectiveness for any use that has not received clearance or approval.

SOURCE Bridge to Life, Ltd.