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
New clinical data presented at the 2026 American Transplant Congress in Boston indicate that hypothermic oxygenated perfusion (HOPE) using the VitaSmart System is a feasible method for preserving donor uterus and small intestine grafts. Researchers found that this technology, which is currently FDA-cleared for liver transplants, may improve mitochondrial metabolism and reduce ischemic injury in these additional organ types.
Did You Know? Researchers utilized flavin mononucleotide (FMN) as a biomarker during the study to measure organ viability, as this molecule serves as an indicator of mitochondrial health during machine perfusion.
How HOPE impacts organ preservation
According to findings presented by the Cleveland Clinic, hypothermic oxygenated perfusion (HOPE) supports organ quality by stabilizing mitochondrial metabolism. In a study of six donor uteri, researchers observed that eight hours of HOPE resulted in reduced biochemical markers of ischemic injury compared to traditional static cold storage. This study represents what authors believe to be the first report of HOPE applied to human deceased donor uteri.
A separate analysis of 20 discarded human intestines compared HOPE against normothermic machine perfusion (NMP). The study, led by Koki Takase, MD, found that perfusate FMN levels—a marker of mitochondrial damage—were significantly lower in the HOPE group. Researchers concluded that HOPE provided superior preservation of mitochondrial and metabolic function for intestinal grafts before transplantation.
Expert Insight
Expert Insight: The transition of HOPE technology from liver applications to uterus and intestine research marks a significant shift in transplant science. By focusing on mitigating ischemia-reperfusion injury—the damage caused when blood supply returns to tissue after a period of oxygen deprivation—clinicians are attempting to expand the pool of viable donor organs. If validated in larger clinical trials, this approach could address the long-standing gap between the high demand for transplants and the limited supply of organs that meet current clinical standards.
What happens next for transplant research
The application of the VitaSmart System for uterus and intestine transplantation remains investigational and is not included in current FDA-cleared indications. Before this technology moves into standard clinical practice, additional studies will be required to confirm these findings. Future research is expected to incorporate functional validation and larger patient cohorts to determine if machine perfusion can safely facilitate the use of deceased donor uteri and intestines.
Transplant teams may eventually use real-time data, such as FMN monitoring, to objectively assess organ quality before surgery. If these subsequent trials prove successful, clinicians could potentially utilize a wider range of donor organs that are currently declined due to preservation limitations.
Frequently Asked Questions
What is the current FDA status of the VitaSmart System?
The FDA-cleared labeling for the VitaSmart System currently supports its use for the hypothermic oxygenated perfusion of donor livers from both Donation after Brain Death and Donation after Circulatory Death donors.
Did the researchers transplant the uteri used in the study?
No. The uteri were perfused for ex situ research assessment and were not transplanted into human recipients.
Why was HOPE compared to normothermic machine perfusion (NMP) in the intestine study?
Researchers compared the two methods to identify the optimal preservation approach for intestinal transplantation, as outcomes without machine perfusion currently face challenges due to high ischemia-reperfusion injury.
How might the ability to assess organ quality in real-time change the way transplant centers approach donor selection?