Published research
The evidence we build on
Four papers inform the approach behind SOLO-1. Three are randomized trials of machine perfusion versus cold storage. The fourth is a rat study of organ cryopreservation. None of them tested SOLO-1.
Kidney · hypothermic machine perfusion
Machine perfusion or cold storage in deceased-donor kidney transplantation
Moers C, Smits JM, Maathuis MH, et al. Machine perfusion or cold storage in deceased-donor kidney transplantation. N Engl J Med. 2009;360(1):7–19.
In short. Reduced delayed graft function and improved one-year graft survival compared with cold storage in deceased-donor kidneys.
International randomized trial. One kidney from each of 336 deceased donors was assigned to hypothermic machine perfusion and the other to static cold storage. All 672 recipients were followed for one year. The primary end point was delayed graft function, defined as dialysis in the first week after transplant.
Machine perfusion reduced delayed graft function: 70 recipients in the machine-perfusion group versus 89 in the cold-storage group (adjusted odds ratio 0.57). One-year allograft survival was 94% versus 90%. The authors reported no serious adverse events directly attributable to machine perfusion.
This was a trial of hypothermic machine perfusion as used at the time. It was not a study of SOLO-1, and it does not establish the safety or effectiveness of SOLO-1.
doi.org/10.1056/NEJMoa0802289 · PubMed 19118301 · Moers et al., N Engl J Med, 2009
Liver · normothermic machine perfusion
A randomized trial of normothermic preservation in liver transplantation
Nasralla D, Coussios CC, Mergental H, et al. A randomized trial of normothermic preservation in liver transplantation. Nature. 2018;557(7703):50–56.
In short. Lower graft injury and fewer discarded organs than cold storage, with longer preservation times.
Randomized trial of 220 liver transplants comparing normothermic machine perfusion with conventional static cold storage. Normothermic perfusion holds the liver near body temperature instead of on ice.
The trial reported a 50% lower level of graft injury, measured by hepatocellular enzyme release, a 50% lower rate of organ discard, and a 54% longer mean preservation time. It found no significant difference in bile-duct complications, graft survival, or patient survival.
Those results are about normothermic liver preservation in that trial. They are not results for SOLO-1. Generation 1 of SOLO-1 is hypothermic perfusion; normothermic perfusion is a generation 2 plan, not a completed study.
doi.org/10.1038/s41586-018-0047-9 · PubMed 29670285 · Nasralla et al., Nature, 2018
Liver · hypothermic oxygenated perfusion
Hypothermic machine perfusion in liver transplantation — a randomized trial
van Rijn R, Schurink IJ, de Vries Y, et al. Hypothermic machine perfusion in liver transplantation — a randomized trial. N Engl J Med. 2021;384(15):1391–1401.
In short. Fewer symptomatic biliary complications in livers donated after circulatory death.
Multicenter randomized trial (DHOPE-DCD) in livers donated after circulatory death. Recipients were assigned to hypothermic oxygenated machine perfusion or to static cold storage alone. The primary end point was nonanastomotic biliary strictures within six months.
Strictures occurred in 6% of the machine-perfusion group and 18% of the cold-storage group (risk ratio 0.36). The trial also reported less postreperfusion syndrome and less early allograft dysfunction. Adverse events were similar in the two groups.
The short version above is the biliary-complication finding. The published primary end point is nonanastomotic biliary strictures within six months. The trial is not a study of SOLO-1.
doi.org/10.1056/NEJMoa2031532 · PubMed 33626248 · van Rijn et al., N Engl J Med, 2021
Long-term preservation · research
Vitrification and nanowarming of rat kidneys
Han Z, Rao JS, Gangwar L, et al. Vitrification and nanowarming enable long-term organ cryopreservation and life-sustaining kidney transplantation in a rat model. Nat Commun. 2023;14:3407.
In short. Rat kidneys vitrified, stored and rewarmed by nanowarming supported life after transplant. Not yet shown in human organs.
This is not a perfusion trial and not a human study. Rat kidneys were vitrified — cooled into an ice-free, glass-like state — stored for up to 100 days, and rewarmed with nanowarming, which heats nanoparticles in the organ’s vessels. After the nanoparticles were washed out, the kidneys were transplanted and restored life-sustaining renal function in a male rat model.
The same result has not been shown in human organs. It does not show that a human organ, or a whole body, can be preserved and later restored. Bunker Longevity makes no claim of revival.
The paper is background for the long-term research goals on the roadmap. Those goals are not a product commitment, and they are not evidence about the SOLO-1 cradle.
doi.org/10.1038/s41467-023-38824-8 · PubMed 37296144 · Han et al., Nat Commun, 2023
What this list does not show
The kidney and liver trials support machine perfusion over ice in the settings they tested. They do not cover hearts or lungs. Heart and lung cassettes are a later SOLO-1 generation, and these papers are not evidence for that hardware.
No clinical study of SOLO-1 has been completed. The device has not been cleared or approved by the U.S. Food and Drug Administration or any other regulatory authority.
SOLO-1 Organ CradleEngineering notesOrgan perfusionDisclosures