Clinical data show meaningful increases in organ utilization, unlocking new transplant supply in a market constrained by donor shortages

Results demonstrate HOPE expands use of marginal donor organs, increasing transplant availability for the 100,000+ patients awaiting transplants in the U.S.

DULUTH, Ga., May 28, 2026 /PRNewswire/ — Bridge to Life™ Ltd., a global innovator of commercial stage organ preservation and perfusion technologies, today announced a new, pioneering study on organ preservation technologies conclusively demonstrates the efficacy and safety advantages of Hypothermic Oxygenated Perfusion (HOPE) using the innovative VitaSmart™ Perfusion System. The multicenter clinical trial, named Bridge to HOPE by sponsoring company Bridge to Life Ltd., has just been published online in JAMA Surgery. Following is a link to the online publication: https://jamanetwork.com/journals/jamasurgery/fullarticle/2849502. The Bridge to HOPE clinical trial was the pivotal trial reviewed by the U.S. Food and Drug Administration (FDA), leading to the recent de novo clearance of the VitaSmart™ HOPE Perfusion System.

The study, titled “Portal-Venous Hypothermic Oxygenated Perfusion for Liver Transplantation: The Bridge to HOPE Trial,” is the first multicenter, randomized trial conducted in the United States to evaluate the clinical impact of end-ischemic HOPE through the portal vein alone in liver transplantation using high-risk extended criteria donors, including both Donation after Brain Death (DBD) and Donation after Circulatory Death (DCD) grafts. The study enrolled 219 recipients across 15 U.S. transplant centers and was performed using the investigational VitaSmart™ HOPE System. The study focused on higher-risk donor organs, where advanced preservation techniques can meaningfully increase utilization and improve post-transplant outcomes.

The protocol was designed with a blinded central assessment of complications and achieved early closure due to statistically superior results for the VitaSmart arm.

The VitaSmart™ HOPE System was recently launched in the US for use with donor livers following static cold storage and prior to transplantation. The FDA de novo clearance established a new regulatory classification for hypothermic oxygenated perfusion in liver transplantation in the United States.

“These study results clearly demonstrate the transformational opportunity VitaSmart provides the transplant community.  This study demonstrated that portal venous HOPE offers a simple, safe, and effective preservation strategy with significant clinical benefits, and provides a scalable, logistically feasible alternative to normothermic machine perfusion, especially in the U.S. context of currently limited perfusion infrastructure,” stated Mauricio Carvalho, VP of Medical Affairs at Bridge to Life Ltd. “Overall liver-related complications were also significantly reduced by this perfusion approach.”

“We are thrilled to see the publication of this seminal study in the JAMA Surgery” commented Don Webber, CEO and President of Bridge to Life. “Despite clear clinical validation, only a fraction of transplanted livers were perfused in the U.S. due to operational and logistical complexity, and cost. Bridge to Life is focused on removing those constraints with a solution that integrates seamlessly into transplant workflows, enabling scalable adoption.  Now the transplantation and surgical communities, as well as thousands of patients in the U.S. awaiting organ transplants can gain a greater appreciation for this novel organ preservation technology, and why Bridge to Life has been working tirelessly to complete the research required for launch in the US.”

About Bridge to Life™ Ltd

Bridge to Life™ Ltd is a market leader in organ preservation solutions, offering premier products such as VitaSmart™ Hypothermic Oxygenated Perfusion System, Belzer UW^®and EasiSlush^®. With a strong focus on product quality, innovation and accessibility, the company serves and partners with leading transplant centers and organ procurement organizations globally.

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SOURCE Bridge to Life, Ltd.