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Monday 27 February, 2012

Lifeline Scientific

Machine Preservation 3 Year Study

RNS Number : 1355Y
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 Trial1. The Machine Preservation Trial was the first large, randomised, prospective trial to compare the preservation of kidneys for transplant via LifePort® 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 year2 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® 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 transplantation3 ‑ 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


 

1Moers 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.

2Moers 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
 
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