Portuguese Transplant Center Analysis of First 100 Cases of Hypothermic Oxygenated PErfusion (HOPE) in Liver Transplantation Demonstrates Increased Use of Marginal Grafts, Making More Livers Available for Transplantation

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The analysis is being presented this week at the American College of Surgeons Clinical Congress 2024 (ACS 2024) in San Francisco, California, October 19-22, 2024

CHICAGO, Oct. 21, 2024 /PRNewswire/ -- Bridge to Life is pleased to announce an analysis of 100 cases of liver transplantations at a Portuguese Transplant Center demonstrates that the use of Hypothermic Oxygenated PErfusion (HOPE) has the potential to lower the incidence of complications and maximizes the use of donor organs with extended criteria. The analysis is presented this week at the Clinical Congress 2024 of the American College of Surgeons (ACS) in San Francisco, California, October 19-22, 2024.

"In our analysis, HOPE increased the use of marginal grafts and provided good function of the grafts in the immediate postoperative period," said Maria João Amaral, General Surgery Department - Unidade Local de Saúde de Coimbra, Portugal and principal investigator of the analysis. "In addition, there was a decrease in the non-anastomotic strictures (NAS) rate in our Center," she added.

The analysis was conducted using data collected between August 2020 and July 2023, from 100 cases of liver transplants efficiently using HOPE. Data were analyzed from the donor, graft and recipient, and from the intra and postoperative period. The development of non-anastomotic strictures (NAS) was also analyzed after excluding patients with arterial complications and biliary cast syndrome. NAS incidence was 6.98% (N=86) and 7.69% for cases with follow-up >6 months (N=65) (previously estimated at 16.9% at the Coimbra Transplant Center).

HOPE cools the organs to temperatures between 4 and 12°C, dramatically lowering their metabolic rate to roughly 10% of normal. The system also delivers oxygenated perfusion to the dormant organ as it awaits transplantation. This oxygen-rich environment revitalizes the mitochondria—the cell's powerhouse—priming the cells before transplantation and potentially lowering the risk of reperfusion injury, a major contributor to post transplant complications.

"This Portuguese analysis of 100 cases of livers perfused with HOPE is further evidence of the value that the use of HOPE brings to increasing the supply of available livers for transplantation, potentially improving access for those in need of livers and reducing waiting time for transplantation," commented Don Webber, CEO and President of Bridge to Life Ltd., a leading provider of transplant solutions and innovative technologies. "We are in the final stages of assessing the 1-year follow-up results of our HOPE Trial in the U.S. and look forward to bringing this innovative technology to U.S. transplant centers, organ procurement organizations, and, most importantly, to patients in need of viable livers," he added.

The company successfully completed its pivotal, U.S. multicenter, randomized clinical trial in 2024 and expects to submit for FDA approval in early 2025. The trial met criteria for early closure based on statistical significance for non-inferiority and superiority of early allograft dysfunction following HOPE with VitaSmart compared to cold storage only.

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 VitaSmart¹ Machine Perfusion System. With a strong focus on product quality, innovation and accessibility, the company serves and partners with leading Transplant Centers and Organ Procurement Offices (OPO) globally.

¹ VitaSmart is CE Marked and available for sale in several markets outside of the United States. VitaSmart is not approved for sale in the US. The company successfully completed its pivotal, multicenter, randomized clinical study in the US in 2023 and expects to submit for approval to FDA in Q125^.  

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