New Investigator Initiated Research Data Demonstrate Efficacy and Safety of the Bridge to Life's VitaSmart™ Hypothermic Oxygenated Perfusion (HOPE) System in Multiple Organ Transplants

Studies in human uterus and small intestine transplants, including head-to-head comparison with normothermic oxygenated perfusion, presented at 2026 Annual Meeting of the American Transplant Congress (ATC) in Boston

DULUTH, Ga., June 23, 2026 /PRNewswire/ -- New clinical data presented at the 2026 Annual Meeting of the American Transplant Congress (ATC) this week have demonstrated that hypothermic oxygenated perfusion (HOPE) delivered using the VitaSmart System was feasible and was associated with favorable preservation parameters in human uterus and small intestine research grafts, further supporting the potential for HOPE to benefit multiple organs in future transplantation research. The FDA-cleared labeling for VitaSmart™ currently supports hypothermic oxygenated perfusion of donor livers prior to transplantation in both Donation after Brain Death (DBD) and Donation after Circulatory Death (DCD) donors, within defined donor criteria. The studies were presented orally, one during the Plenary Session.

"At Bridge to Life, we are continuing to advance the state of the art of donor organ preservation with our innovative VitaSmart™ HOPE System," said Don Webber, president and CEO of Bridge to Life, a global innovator in organ preservation and perfusion technologies. "Following the FDA clearance of the VitaSmart™ System with HOPE for donor livers prior to transplantation in both DBD and DCD donors, this new data has shown that HOPE with VitaSmart™ has application and significant benefits for multiple organ transplants."

"HOPE for Human Uterus Transplantation: Improved Preservation and Viability Assessment for Enhanced Donor Utilization," Keyue Sun, MD, Cleveland Clinic, et al

Cleveland Clinic study authors explained that uterus transplantation (UTx) is an emerging treatment for absolute uterine factor infertility. However, the use of deceased donors is limited, and DCD has not yet been utilized. Ischemic injury remains a major barrier, particularly compared with living donor procedures. HOPE, which has shown protective effects in heart, liver, and kidney transplantation, may offer similar benefits for uterine grafts.

Their observations are consistent with Cleveland Clinic experience from liver, kidney, and heart transplantation. In those organs, HOPE has been shown to reduce ischemia reperfusion injury and improve early graft function, especially in extended-criteria and DCD organs.

To their knowledge, study authors believe their study represents the first report describing HOPE in human deceased donor uteri and describes the associated metabolic and mitochondrial responses during perfusion. Researchers from Cleveland Clinic Foundation have been investigating mitochondrial metabolism during machine perfusion, using flavin mononucleotide (FMN) as a potential biomarker of organ viability and quality in transplantation.

Six uteri (3 DBD, 3 DCD) underwent eight hours of HOPE following procurement, while paired tissue controls were preserved using static cold storage (SCS). Perfusion was delivered using a pressure-controlled system. Perfusate and tissue samples were analyzed for mitochondrial injury, inflammation, and transcriptional responses. The uteri were perfused for ex situ research assessment and were not transplanted into recipients.

The study results showed that HOPE was associated with improved preservation by supporting mitochondrial metabolism and reducing biochemical markers of ischemic injury during perfusion, such as perfusate FMN. These findings provide initial human evidence that hypothermic oxygenated perfusion may serve as a preservation and metabolic assessment platform for deceased donor uterus grafts. Future studies incorporating reperfusion models, functional validation, and larger cohorts will be essential to determine whether machine perfusion can facilitate safer utilization of deceased donor uteri and support broader clinical application of uterus transplantation.

"Comparison of Hypothermic Oxygenated and Normothermic Machine Perfusion of Human Small Intestine for Transplantation," Koki Takase, MD, Cleveland Clinic, et al

Also at Cleveland Clinic, study authors explored the use of machine perfusion (MP) in the preservation of small intestine grafts prior to Intestinal transplantation (IT). To date, the authors state that intestinal transplant outcomes without machine perfusion face challenges due to high ischemia-reperfusion injury (IRI) and subsequent elevated immunogenicity of the grafts. MP techniques were shown to reduce IRI-related inflammation and improve outcomes in other solid organ transplantation, but its application for IT remains limited. This study compared the effects of HOPE and Normothermic Machine Perfusion (NMP) of human intestine to assess the condition after MP and identify the optimal approach for IT.

Twenty discarded intestines were included in this analysis (HOPE: 12, NMP: 8), and were perfused through HOPE, NMP after SCS. Perfusates and intestine tissue were assessed for mitochondrial injury, metabolic activity, IRI-associated inflammation, and epithelial injury.

The study found that perfusate FMN, a marker of mitochondrial injury, was significantly lower in the HOPE group than with NMP — indicating less mitochondrial damage during preservation. Perfusate release of mitochondrial complex I and II followed the same pattern, also significantly lower with HOPE.

Study authors concluded that end-ischemic (i.e., after SCS and before transplantation) HOPE of human intestine preserved the mitochondrial and metabolic function best compared to NMP. A pilot study is requested to proceed with the clinical application of HOPE for IT.

"These early findings in the uterus and small intestine organs present a potential opportunity for Bridge to Life to enter into new markets which have never been unlocked," said Mauricio Flores Carvalho, vice president of Medical and Scientific Affairs at Bridge to Life. "In both intestine and uterus, the number of transplants performed each year reflects the limits of preservation, not the limits of need. The injury an organ sustains while it waits is what forces clinicians to decline donors and discard organs that patients are waiting for. By protecting the organ during preservation and giving the transplant team an objective, real-time read on its quality, such as perfusate FMN, HOPE has the potential to turn organs we cannot use today into ones we can. That conversion is what expands these fields."

About these Abstracts

Use of VitaSmart System in uterus and intestine research described in these abstracts was investigational and is not included in the current FDA-cleared indications.  Clinical application of HOPE in these organs would require additional studies and regulatory review.

About Bridge to Life™ Ltd

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

SOURCE Bridge to Life, Ltd.