Bridge to Life Wins Canada License, FDA Breakthrough Status

Duluth, Georgia, USA, November 3, 2026

Health Canada License Expands VitaSmart Availability in Canada

The Health Canada Medical Device License represents an important commercial milestone for Bridge to Life, allowing its VitaSmart® HOPE System to be introduced to liver transplant centers across Canada. The device is designed to perform hypothermic oxygenated perfusion of donor livers, a preservation technique that circulates cold, oxygenated preservation solution through an organ before transplantation. This approach is intended to help mitigate ischemic injury, which occurs when organs experience reduced oxygen supply during the period between donation and transplantation. By providing oxygen during preservation, the HOPE technology aims to support organ condition and help transplant specialists evaluate and utilize suitable donor livers. VitaSmart® is designed as a portable and operationally versatile system that can be incorporated into existing transplant workflows. Bridge to Life plans to work with Canadian liver transplant surgeons and healthcare teams to introduce the technology into the country’s transplantation network. The company also participated in the Canadian Society of Transplantation Annual Scientific Meeting held in Montreal, Quebec, in October 2026, highlighting its engagement with the Canadian transplantation community. The Canadian authorization builds on the system’s existing international presence, as VitaSmart® is already used for liver and kidney preservation in Europe and is available in Saudi Arabia, India and markets accepting the CE mark.

FDA Breakthrough Device Designation Advances Intestinal Research

Alongside its Canadian regulatory achievement, Bridge to Life announced that the FDA has granted Breakthrough Device Designation for the investigational application of VitaSmart® in donor intestine preservation. The designation focuses on hypothermic oxygenated perfusion of donor intestines, an emerging area of transplantation research where organ preservation remains particularly challenging. The intestine is highly sensitive to ischemic injury, making effective preservation technologies important for improving the management of donated organs. The FDA Breakthrough Devices Program is intended to facilitate development and provide prioritized interaction and review for medical devices that may offer more effective treatment or diagnosis of life-threatening or irreversibly debilitating conditions. However, Breakthrough Device Designation does not mean FDA approval or clearance, and the intestinal application of VitaSmart® remains investigational. The designation provides an opportunity for continued regulatory engagement as the company advances research and development in this area. Previously, in January 2026, the FDA granted De Novo clearance for the VitaSmart® System for hypothermic oxygenated perfusion of donor livers following static cold storage, within specified donation-after-brain-death (DBD) and donation-after-circulatory-death (DCD) donor criteria. The latest designation therefore represents a further development in the company’s strategy to expand its technology platform beyond liver transplantation.

Clinical Evidence Supports Organ Preservation Innovation

Clinical research and ongoing development remain important components of Bridge to Life’s efforts to advance organ preservation technologies. The company’s Bridge to HOPE randomized controlled trial, conducted across 15 U.S. transplant centers and involving 219 recipients, evaluated the VitaSmart® HOPE System in liver transplantation. According to the company, the study demonstrated improved early allograft function in recipients whose donor livers were preserved using the technology. These findings support continued investigation into oxygenated machine perfusion as an approach to addressing organ preservation challenges. Beyond liver and intestine applications, Bridge to Life is also supporting investigator-led studies evaluating VitaSmart® for pancreas preservation. The company’s broader objective is to develop a versatile, multi-organ preservation platform that can support transplantation programs across different clinical settings. Its portfolio also includes Belzer UW®, an established organ preservation solution widely used in abdominal organ transplantation. By combining established preservation products with advanced perfusion technologies, Bridge to Life aims to provide transplant centers with additional tools for managing donor organs and supporting clinical workflows. Overall, the latest Health Canada authorization and FDA Breakthrough Device Designation mark important regulatory and commercial developments for the company, while highlighting the growing role of medical technology innovation in organ transplantation and preservation.

Source: Bridge to Life press release