Bridge to Life™ Achieves Major Progress in North America with Regulatory Approvals

Bridge to Life™ Expands Its North American Presence

Bridge to Life™ Ltd., a pioneering player in the field of organ preservation and perfusion technologies, has recently shared incredible news regarding its operations in North America. With the approval of two vital regulatory milestones, the company is strategically enhancing its market footprint and driving innovation in the healthcare sector.

Regulatory Milestones Achieved

On November 3, 2026, Bridge to Life announced that Health Canada awarded a Medical Device License for its VitaSmart® Hypothermic Oxygenated Perfusion (HOPE) System, effectively opening the Canadian market for this life-saving technology. This system is specifically designed for the hypothermic oxygenated perfusion of donor livers and strengthens the operational capabilities of transplant centers throughout Canada.

In addition, the U.S. Food and Drug Administration (FDA) has designated the VitaSmart® System as a Breakthrough Device for investigational use in hypothermic oxygenated perfusion of donor intestines. This designation allows for prioritized assessment by the FDA, thereby accelerating the potential introduction of the device to treat transplantation patients in critical need.

Addressing the Organ Shortage Crisis

Currently, more than 4,000 people in Canada and over 100,000 individuals in the U.S. are waiting for life-saving organ transplants. The growing demand underscores a significant shortage of transplantable organs, presenting one of the most pressing challenges in transplant medicine today. The VitaSmart® platform directly tackles this issue by mitigating ischemic injury, which in turn supports the optimal utilization of available donor livers while enhancing outcomes for transplant recipients.

Clinical trials, such as the Bridge to HOPE randomized controlled trial involving 219 participants across 15 transplant centers, have demonstrated that the VitaSmart® HOPE system significantly improves early allograft function in liver transplants.

Expanding Global Market Potential

With these recent accomplishments, Bridge to Life is positioned to expand its influence beyond the shores of North America. The company is not only ready to market the VitaSmart® system in Canada but is also exploring opportunities for its use in several other markets, including regions in Europe, Saudi Arabia, and India.

The recent spotlights at events like the Canadian Society of Transplantation (CST) Annual Scientific Meeting emphasize the company’s commitment to collaborating with healthcare professionals in Canada to meet modern transplantation needs and advocate for innovative solutions.

“Securing our Canadian market authorization alongside FDA Breakthrough Device Designation continues to accelerate momentum in our global commercial trajectory,” stated Don Webber, President and CEO of Bridge to Life. “Our vision focuses on alleviating friction points in the transplant care ecosystem. VitaSmart® is designed to be portable, operationally versatile, and easily integrated into clinical workflows.

By empowering surgical teams with better preservation options, we strive to facilitate the usage of a greater number of available organs, enhance recipient outcomes, and, ultimately, save more lives.”

Looking Ahead

The potential for saving lives is amplified with the new authorization achieved in Canada, which allows Bridge to Life to roll out the VitaSmart® system to liver transplant surgeons and care teams nationwide. The aim is to set new standards for organ preservation and significantly improve recipient outcomes.

In addition to its advancements in liver preservation, Bridge to Life is also exploring the system's efficacy in pancreas preservation, backed by promising preliminary studies. Recently, the technology was showcased at the 31st International Congress of The Transplantation Society, highlighting pediatric multivisceral transplant cases that included all abdominal organs.

In conclusion, the achievements of Bridge to Life in both the U.S. and Canada not only reflect the company's innovative spirit but also underscore a greater commitment to enhancing patient care and expanding the potential of organ transplantation in dire circumstances.