DULUTH, Georgia, May 28, 2026
Bridge to Life™ Ltd. has announced the publication of landmark clinical trial results in JAMA Surgery, validating the company’s VitaSmart™ Hypothermic Oxygenated Perfusion (HOPE) System as a superior organ preservation technology for liver transplantation. The multicenter study, known as the Bridge to HOPE Trial, demonstrated significant improvements in organ utilization and transplant outcomes, particularly among higher-risk donor organs that are often discarded due to quality concerns. The findings represent a major advancement in transplant medicine and could help address the ongoing organ shortage crisis affecting more than 100,000 patients currently awaiting life-saving organ transplants in the United States.
Landmark Clinical Trial Demonstrates Superior Organ Preservation
The Bridge to HOPE Trial is the first multicenter, randomized clinical study conducted in the United States to evaluate the effectiveness of portal-vein-only Hypothermic Oxygenated Perfusion (HOPE) in liver transplantation. The study enrolled 219 liver transplant recipients across 15 transplant centers and focused on extended criteria donor organs, including both Donation after Brain Death (DBD) and Donation after Circulatory Death (DCD) grafts.
Using the investigational VitaSmart™ HOPE Perfusion System, researchers assessed whether advanced organ preservation techniques could improve outcomes for higher-risk donor organs that traditionally face lower utilization rates. The study achieved such strong clinical results that it was closed early after meeting predefined statistical superiority criteria. Independent blinded assessments confirmed significant reductions in complications among patients receiving livers preserved with the VitaSmart system.
The publication in JAMA Surgery, one of the world’s most respected surgical journals, provides strong scientific validation for the technology and reinforces the growing role of machine perfusion in modern transplantation medicine.
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Expanding Donor Organ Availability Through Advanced Perfusion Technology
One of the most significant findings from the study was the ability of the VitaSmart HOPE System to increase utilization of marginal donor organs. Organ shortages remain one of the greatest challenges facing transplant medicine, with thousands of potentially transplantable organs discarded each year because of concerns regarding preservation quality and post-transplant performance.
The VitaSmart system utilizes Hypothermic Oxygenated Perfusion, a technique that delivers oxygenated preservation solution through the portal vein while maintaining the organ at low temperatures. This process helps reduce ischemic injury, improve cellular recovery, and enhance organ viability before transplantation. By improving preservation quality, transplant teams can confidently utilize donor livers that may otherwise have been rejected.
Researchers reported significant reductions in overall liver-related complications while maintaining a simple and scalable workflow that can be integrated into existing transplant practices. Unlike some alternative perfusion technologies that require extensive infrastructure, specialized staffing, and higher operational costs, the VitaSmart platform offers a practical approach that can be more easily adopted across transplant centers.
The ability to safely expand access to higher-risk donor organs has the potential to substantially increase the available organ supply while improving outcomes for patients facing lengthy waiting periods.
FDA Clearance and Future Impact on Transplant Medicine
The clinical trial served as the pivotal study supporting the U.S. Food and Drug Administration’s De Novo clearance of the VitaSmart™ HOPE Perfusion System. The authorization established a new regulatory classification for hypothermic oxygenated perfusion technologies in liver transplantation within the United States, creating an important milestone for the field.
Bridge to Life recently launched the VitaSmart system commercially for use with donor livers following static cold storage and prior to transplantation. Company executives believe the technology can remove operational barriers that have limited broader adoption of organ perfusion systems despite growing clinical evidence supporting their effectiveness.
As transplant centers continue seeking solutions to increase donor organ utilization and improve patient outcomes, the VitaSmart HOPE System offers a compelling combination of clinical efficacy, safety, scalability, and workflow simplicity. The publication of the Bridge to HOPE Trial provides robust evidence that advanced preservation technologies can play a critical role in addressing donor shortages while improving transplantation success rates.
With increasing pressure on healthcare systems to maximize every available donor organ, Bridge to Life’s VitaSmart HOPE System may represent one of the most important innovations in organ preservation and transplantation in recent years, potentially expanding access to life-saving procedures for thousands of patients awaiting transplants worldwide.
Source: Bridge to Life press release
