In News

To the Organ Transplantation Community,

We are just wrapping up the trifecta of Spring 2024 national and global congresses for the transplantation community: the European Liver and Intestine Transplant Association (ELITA) Summit 2024, organized by European Society for Organ Transplantation (ESOT) in April; the 2024 Annual Congress of the International Liver Transplantation Society (ILTS) in May; and now the just-completed American Transplant Congress (ATC), the Joint Annual Meeting of the American Society of Transplant Surgeons (ASTS) and the American Society of Transplantation (AST). Each congress/meeting contributed significantly to the research and literature that advance innovation for transplant professionals and recipients.

For Bridge to Life, the meetings provided a major opportunity to present the latest data on the use of HOPE (Hypothermic Oxygenated Perfusion), in conjunction with our VitaSmart Machine Perfusion technology.

Here’s our news from ATC 2024:

We announced the latest findings from the Bridge to HOPE clinical trial, utilizing the VitaSmart Machine Perfusion System. The trial 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, involving 219 participants, produced the following key results:

  • 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.

These results, along with data from other HOPE studies conducted in Europe, collectively validate the safety and effectiveness of this therapy. Moreover, the ease of use and significant cost difference between normothermic and HOPE systems position this device to be highly disruptive in the current US market, where the only option for perfusing organs today is an extremely expensive and highly complex normothermic system. Also, despite objective clinical evidence showing that perfusion is superior to static cold storage regardless of whether perfusing with a normothermic or hypothermic system, many transplant centers struggle with deciding when to use perfusion due to its high cost, often reserving it for higher-risk organs. At Bridge to Life, our goal is to make this therapy affordable and accessible for all liver transplants.

Other ATC 2024 presentations included:

Liver/Surgery innovative Techniques (Rapid File Oral Abstract): Decreased Ischemic Cholangiopathy With Hypothermic Oxygenated Perfusion: Sub Analysis Of Biliary Outcomes From The Us Pivotal Multicenter Trial Of The VitaSmart For Hope In Liver Transplantation, D. Reich, Cleveland Clinic, Weston, FL et al.

Clinical Trials (Rapid File Oral Abstract): Early Allograft Dysfunction As A Clinical Trial Primary Outcome Measure Correlates With Later Outcomes; Analysis From A US Pivotal Multicenter Medical Device Trial Of Hypothermic Oxygenated Perfusion For Liver Transplant, D. Reich, Cleveland Clinic, Weston, FL et al.

Poster Session: Economic Assessment Of Hypothermic Oxygenated Machine Perfusion In Liver Transplantation: Interim Analysis, D. Axelrod, University of Iowa, Iowa City, IA et al.

Our news from ILTS 2024 included:

Samuel James Tingle, MD, et al, Newcastle University, Translational and Clinical Research Institute, Newcastle, United Kingdom, presented his meta-analysis of seven clinical trials, Machine perfusion in liver transplantation; Cochrane review and meta-analysis, and confirmed significant improvement in several parameters with HOPE compared to static cold storage and normothermic machine perfusion (NMP). While both technologies proved to be superior to SCS, there is no good evidence that NMP has the same benefits over SCS in terms of these clinically relevant outcomes.

Other ILTS 2024 abstracts included:

Hypothermic oxygenated perfusion (HOPE): Results of our experience in the first 31 liver transplants, Dora Gomez Pasantes, MD et al, University Hospital of A Coruña, A Coruña, Spain

Impact of hypothermic organ perfusion in small grafts in living donor liver transplantation to avoid small-for-size syndrome: safety & feasibility pilot study- phase-I HOPE-L trial, M. Pardasani, MD, M. Rela, MD et al, Dr Rela Institute and Medical Centre, Bharath Institute of Higher Education and Research, Chennai, India

Single center evolution of DCD donor utilization for liver transplantation: from perceived marginality to routine and beyond, Matteo Ravaioli, MD, PhD, et al, University of Bologna, Bologna, Italy

Machine perfusion, an ace up your sleeve: unlocking liver graft potential from donation after circulatory death and previously rejected extended criteria donors, Matteo Ravaioli, MD, PhD, et al, University of Bologna, Bologna, Italy

As you can see, we have been quite thorough and comprehensive in our research and confirmation of early results of the use of HOPE for liver transplantation. We remain optimistic about results-to-date, and are on track to complete the trial later this year. We then plan to submit a PMA to the U.S. Food and Drug Administration by the end of 2024.

While we have a full schedule of regional and local presentations during the summer months, we are looking forward to the 30th International Congress of The Transplantation Society (TTS 2024) to be held in Istanbul, Turkey, September 22-25, 2024. We hope to see you there!

Again, I welcome hearing from you.

Don Webber
President and Chief Executive Officer
Bridge to Life Ltd.