TIDMLSI
Lifeline Scientific, Inc
27 February 2012
27 February 2012
Lifeline Scientific, Inc
("Lifeline" or "the Company")
Machine preservation significantly improves kidney transplant
survival over three years
New England Journal of Medicine publishes update on landmark
Machine Preservation Trial
Lifeline Scientific, the medical technology company, announces
the publication of three year follow-up data in the New England
Journal of Medicine on the landmark Machine Preservation Trial(1) .
The Machine Preservation Trial was the first large, randomised,
prospective trial to compare the preservation of kidneys for
transplant via LifePort(R) Kidney Transporter (marketed through the
Company's Organ Recovery Systems division) with the traditional box
of ice (static cold storage).
Highlights:
-- Overall, the benefits in graft survival seen at 1 year(2)
with LifePort machine perfusion persist after 3 years compared to
traditional cold storage methods
-- The results show that three year graft survival is
significantly greater in all transplanted kidneys machine perfused
in the LifePort(R) Kidney Transporter compared static cold storage
(91% vs. 87%, p=0.04)
-- The graft survival difference at three years was most
pronounced for kidneys from expanded criteria donors* (86% vs. 76%,
p=0.01)
-- Significantly, the results show that three year graft
survival after machine perfusion compared to static cold storage
was significantly superior for kidneys donated after brain death
(91% vs. 86%, p=0.02)
-- Machine-perfused kidneys with delayed graft function (DGF) --
a delay in the recovery of renal function that requires dialysis
within the first week after transplantation(3) -- had better three
year graft survival (77%) than cold stored kidneys with DGF
(62%)
*Expanded criteria donors (ECDs), are those over the age of 60
or those over 50 with health conditions such as high blood
pressure, stroke or poor kidney function. Over the last decade,
kidney donations from ECDs have increased considerably and today
comprise nearly half of the deceased donor kidneys transplanted in
the US and EU.(4,5)
David Kravitz, Chief Executive of Lifeline, said: "The results
of this follow-up study are very encouraging. Because DGF cannot be
predicted with certainty at the time of organ donation, and it is
an established fact that a significant number of deceased donor
kidney transplants experience DGF, the 3-year data demonstrates
that, versus the traditional box of ice, LifePort machine perfusion
is the best preservation modality from a patient outcomes
perspective as it significantly improves the odds that a
transplanted kidney will not experience DGF or fail within three
years post transplant. Moreover, the trial demonstrated that
results are all the more favorable for transplanted kidneys from
expanded criteria donors."
Lead author Cyril Moers, MD PhD, University Medical Center
Groningen, The Netherlands, said: "It is very interesting to see
that the benefits in graft survival seen in this landmark study at
1 year with machine perfusion persist after 3 years compared to
traditional cold storage methods. Since a growing number of organs
available for transplantation come from older donors or from people
with more complex medical conditions, it is particularly welcome
that machine perfusion offers significant improvements for 3-year
graft survival in kidneys from these donors and is a real step
forward in kidney transplantation."
About the trial
-- The Machine Preservation Trial was a landmark,
investigator-driven study, run by an independent scientific
steering committee across the Netherlands, Belgium and the German
federal state of North Rhine Westphalia, in collaboration with the
Deutsche Stiftung Organtransplantation and Eurotransplant
International Foundation (the international organ exchange
organisation for Austria, Belgium, Croatia, Germany, Luxembourg,
The Netherlands and Slovenia) as the central trial assistance desk.
Principal investigators were Rutger Ploeg (Oxford, United Kingdom
and Groningen, The Netherlands), Andreas Paul (Essen, Germany) and
Jacques Pirenne (Leuven, Belgium).
-- The study was the first large randomised, prospective trial
to compare machine perfusion with traditional cold static
storage.
-- Three-year follow-up data were collected on all 672
recipients of consecutive kidneys donated after brain death or
after cardiocirculatory death in the main data set, as well as 164
recipients of kidneys donated after cardiocirculatory death in the
extended data set. One kidney from each of the 336 pairs included
was randomly assigned to machine perfusion, and the contralateral
organ to cold storage.
-- Earlier 12 month results from the Machine Preservation Trial,
also published in the New England Journal of Medicine, showed that
in transplanted kidneys preserved and transported in the LifePort
Kidney Transporter, the odds of experiencing a delay in recovery of
kidney function were 43% lower, and that these kidneys were 48%
less likely to fail within a year compared to those stored in the
traditional box of ice.
About the LifePort Kidney Transporter
LifePort is a proprietary medical device that preserves a
donated kidney before it is transplanted. Designed to provide a
sealed and sterile environment from the time of recovery until
transplantation, LifePort gently pumps a specifically formulated
solution through the kidney. This is referred to as 'machine
perfusion' and is an important contrast to the traditional method
of storing and transporting donated kidneys - packed in a box of
ice (static cold storage).
About Lifeline Scientific Inc.
Lifeline Scientific, Inc. is a Chicago-based global medical
technology company with European regional offices in Brussels, and
South American regional offices in Sao Paulo. The Company's focus
is the global commercialisation of products to improve the
preservation of organs for transplantation with its lead product,
the FDA cleared, and CE marked, and clinically validated LifePort
Kidney Transporter. Devices for preservation of the liver,
pancreas, heart, and lung are in late stage pre-clinical
development.
For further information please contact:
Lifeline Scientific, Inc. +1 847-294-0300
David Kravitz, CEO
Seymour Pierce +44 (0)20 7107 8000
Sarah Jacobs / Mark Percy (Corporate
Finance)
David Banks (Corporate Broking)
FTI Consulting +44 (0)20 7831 3113
Simon Conway / John Dineen
(1) Moers C, Pirenne J, Paul, A, Ploeg RJ. Machine perfusion or
cold storage in deceased-donor kidney transplantation. N.Eng J Med
2012;366:770-1.
(2) Moers C, Smits JM, Maathuis, MJ et al. Machine perfusion or
cold storage in deceased-donor kidney transplantation .N Engl J Med
2009;360:7-19.
3Johnston TD, Thacker LR, Jeon H et al. Sensitivity of
expanded-criteria donor kidneys to cold ischaemia time. Clin Trans
2004;18:28-32
4Eurotransplant data provided on request.
5OPTN. Available at
http://optn.transplant.hrsa.gov/ContentDocuments/PG_Scorecard_090611.xls#
This information is provided by RNS
The company news service from the London Stock Exchange
END
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