To the Organ Transplantation Community,
It’s hard to believe that the holiday season is upon us again. Most of us probably take this time to reflect on the past year: achievements, setbacks, ups and downs. Then we all look ahead to what will hopefully be a healthy, joyous and potentially more productive new year. We at Bridge to Life are no different.
We are excited to report that 2024 has indeed been a year of profound accomplishments for Bridge to Life. And all our achievements have been in the service of the transplantation community.
Let’s start with our “new” news, then work back through the year.
A Bridge to Life Milestone
First, Bridge to Life is thrilled to share that we have reached a significant global milestone in our journey to support transplantation patients and their providers: Hypothermic Oxygenated Perfusion (HOPE) with our novel VitaSmart Hypothermic Oxygenated Machine Perfusion System has now been successfully used for more than 5,000 liver perfusions worldwide! The milestone procedure was performed at Queen Elizabeth Hospital Birmingham, England, United Kingdom. Birmingham – which carries out all major organ transplants, including heart, lung, liver and kidney – and is the most active transplant centre in Europe with world-leading surgeons and cutting-edge equipment.
We are so gratified and proud that our novel technology has helped preserve more than 5,000 donor livers for transplantation.
Bridge to Life is in the final stages of assessing the 1-year follow-up results of our pivotal, multicenter, randomized HOPE clinical 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. We expect to submit for approval to FDA in Q125.
A Unique Transplantation Collaboration
Bridge to Life also recently announced a unique partnership in the field of organ transplantation that marks a milestone in the development of working relationships between academic research institutions and the biomedical and medical technology industries. We – jointly with ULS Coimbra, one of the largest hospitals in Portugal with a legacy of innovation in organ transplantation – established a collaboration to improve the preservation of livers awaiting transplantation and enhance the quality of life for transplant recipients. The partnership includes the development of video case studies to raise awareness of breakthrough procedures at Unidade de Transplantação Hepática de Adultos, Unidade Local de Saude de Coimbra, Coimbra, Portugal.
This announcement is in conjunction with the 32nd anniversary of ULS Coimbra’s liver transplant program.
The initiative kicks off with the development and launch of a case study demonstrating the important organ transplantation research and procedures being conducted at ULS Coimbra.
New Data Confirming the Value of HOPE
Fall 2024 provided yet another opportunity to showcase an increasing database of clinical studies using Hypothermic Oxygenated Perfusion (HOPE) in conjunction with our novel VitaSmart Hypothermic Oxygenated Machine Perfusion System.
At the American College of Surgeons (ACS 2024) in San Francisco, California, ULS Coimbra Transplant Center presented an analysis of their first 100 cases of Hypothermic Oxygenated Perfusion (HOPE) in liver transplantation. Their study demonstrated that the use HOPE has the potential to lower the incidence of complications and maximizes the use of donor organs with extended criteria. The analysis showed increased use of marginal grafts, making more livers available for transplantation.
“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.
At the 30th International Congress of The Transplantation Society (TTS 2024) in Istanbul, Turkey, three Italian studies on HOPE (Hypothermic Oxygenated Perfusion) in liver transplantation were presented focusing on the safety of HOPE, its effectiveness in improving outcomes in redo-liver transplantation, and its potential for evaluating biomarkers of liver viability.
“Our academic research centre has been at the forefront of evaluating the impact of HOPE in several aspects of liver transplantation,” said Dr Damiano Patrono, MD, Liver Transplant Unit, AOU Città della Salute e della Scienza di Torino, Italy and principal investigator of the three trials. “We continue to be impressed with 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,” he further commented.
Presentations included:
Outcomes of redo-liver transplantation using hypothermic oxygenated machine perfusion: a multicentre cohort study (REDO-HOPE), D. Patrono (General Surgery 2U – Liver Transplant Unit, AOU Città della Salute e della Scienza di Torino), et al
VIEW FULL ABSTRACT HERE
Hypothermic oxygenated machine perfusion is not associated with an increased risk of infection in the recipient: A retrospective single-centre cohort study, S. Corcione (General Surgery 2U – Liver Transplant Unit, AOU Città della Salute e della Scienza di Torino), et al
VIEW FULL ABSTRACT HERE
Circulating cell-free DNA in liver transplantation: A pre- and post-transplant biomarker of graft dysfunction, T. Carradori (General Surgery 2U – Liver Transplant Unit, AOU Città della Salute e della Scienza di Torino), et al
VIEW FULL ABSTRACT HERE
These results, along with data from other HOPE studies conducted in Europe, continue to collectively validate the safety and effectiveness of HOPE.
Encouraging HOPE Data from ATC 2024
Earlier this year, during the late-breaker clinical trial session at the 2024 American Transplant Congress (ATC) in Philadelphia, PA, Bridge to Life presented the latest results from our end-ischemic HOPE U.S. randomized clinical trial for liver transplantation. These results were confirmatory of previous studies, and showed safety, reduced early allograft dysfunction, and shorter hospital stays with HOPE.
The HOPE clinical trial, utilizing the VitaSmart Hypothermic Oxygenated Machine Perfusion System, evaluates the safety and efficacy of static cold storage (SCS), the current standard for ex-vivo organ preservation, compared to SCS followed by hypothermic oxygenated perfusion (HOPE) prior to the transplantation of extended criteria donation after brain death (DBD) and donation after circulatory death (DCD) livers. The near-complete one-year patient follow-up results involved 219 participants.
Key results included:
- A significant reduction in early allograft dysfunction (EAD) in the HOPE group (20%) compared to the SCS group (37%), the primary endpoint of the trial with a statistically superior finding (p=.003).
- A significantly shorter median hospital stay for the HOPE group (8 days) compared to the SCS group (11 days, p=.04).
- Favorable trends for HOPE, including fewer serious adverse events, lower rates of Clavien-Dindo grade >3 events (HOPE = 51%, SCS = 60%), reduced incidence of clinically significant DCD ischemic cholangiopathy (HOPE = 11%, SCS = 19%), and lower rates of DCD graft failure (HOPE = 7%, SCS = 19%) and re-transplantations.
- No device-related adverse events were reported.
David J. Reich, MD, Surgical Director of the Liver Transplant Program and Chief of Innovative Technology and Therapeutics at the Cleveland Clinic Transplant Center in Weston, FL presented results as Lead Investigator for the trial. “The newest results of the HOPE trial once again showed the promise of dynamic organ preservation,” said Dr. Reich. “We are encouraged by the improved clinical outcomes, and the continued advancement of care for transplant recipients.”
These results followed on the heels of presentations at the European Liver and Intestine Transplant Association (ELITA) 2024 Summit meeting in Madrid, Spain (Portuguese and Italian studies); and the 2024 International Congress of the International Liver Transplantation Society (ILTS) in Houston, Texas. The latter was a late-breaker meta-analysis of British data.
Bridge to Life Engages with Global Transplantation Experts
On a personal note, one of the professional highlights of my year was a sit-down, one-on-one conversation with Dr. Andrea Schlegel, an esteemed academic transplant surgeon at the Cleveland Clinic Transplant Center and Lerner Research Institute. Dr. Schlegel specializes in liver transplantation and hepatobiliary surgery, with interests in both experimental and clinical research, particularly focused on organ preservation.
Among the many topics we covered, I was particularly intrigued by our discussion of the role of mitochondria in preserving organs for transplantation. Through the use of Hypothermic Oxygenated Perfusion (HOPE), in conjunction with our VitaSmart Hypothermic Oxygenated Machine Perfusion System, organs are cooled to temperatures typically ranging between 4 and 10°C, significantly reducing their metabolic rate to about 10% of normal. The system delivers oxygenated perfusion to the dormant organ while it awaits transplantation. Crucially, this oxygen-rich perfusion revitalizes the mitochondria, the powerhouse and energy reservoir of the cells. Essentially, this process primes the cells before transplantation, optimizing clinical outcomes and potentially mitigating the dreaded reperfusion injury that many transplant patients experience shortly after the life-saving surgery.
Dr. Schlegel shared her point of view: “When we have organs…we always have to transfer them to a new recipient, of course, so they have a period where they have no oxygen, because no perfusion, no heart action, no blood going through them. We take them out and transport them in ice, usually, to the recipient center, and then we transplant them or connect them to the new patient. And in that time, the tissue suffers a lot and biochemically there’s a lot of mechanisms ongoing. The problem is you accumulate toxic metabolites during that ischemia and these metabolites trigger then the whole injury after you reperfuse. When you give oxygen back when you reconnect them, you perfuse them on a machine or you implant them in a recipient. So how can we prevent this cytokine storm and this radical release, which happens as soon as you give oxygen back in the first minute? When we look at the different preservation methods that we have the icebox is mainly a transport and cooling which slows down the metabolism it prevents or the idea is to prevent further injury, but while the organ is in the icebox, the injury actually accumulates or happens, then we have hypothermic perfusion. If you give oxygen in a low metabolic state in the cold, the difference is that you can reduce the injury, so you give oxygen and the restoration in the cell starts.”
I contend that hypothermic systems provide a more sustainable and efficient option than normothermic systems, without disrupting existing clinical workflows; and I believe exploring alternative methods for recharging mitochondria and mitigating reperfusion injury is crucial for the progression of organ perfusion technologies.
Wrapping Up and Looking Ahead
Our commitment to you, our colleagues in the transplantation community, for unparalleled quality products and service remains strong.
Once again, we look forward to an exciting 2025, with our filing with the U.S. Food & Drug Administration of our HOPE data anticipated for the First Quarter 2025; and to the several professional conferences, including American Society of Transplantation’s World Transplant Congress, scheduled for August 2-6 in San Francisco, California. Looking forward to seeing you there.
Finally, if we don’t meet or speak again as the year concludes, on behalf of all of us at Bridge to Life, please accept my very warm wishes for a healthy and prosperous holiday season and New Year. We are eternally grateful for all our colleagues in the transplantation community.
Again, I welcome hearing from you regarding what would be valuable in these updates moving forward. You can reach out to me at BTLBlog@b2ll.com.
Don Webber
President and Chief Executive Officer
Bridge to Life Ltd.
VitaSmart is CE marked and available for sale in several markets outside of the United States. VitaSmart is not approved for sale in the U.S. 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.
