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Lifeline Scientific (LSI)

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Thursday 18 June, 2009

Lifeline Scientific

Research Update

RNS Number : 0966U
Lifeline Scientific, Inc
18 June 2009
 



18 June 2009


Lifeline Scientific, Inc('Lifeline' or 'the Company')Trial Results Published at American Transplant Congress


Data from non-heart beating donors and donors over 65 further underline clear advantages of machine perfusion over traditional ice box storage for kidney transplants 


Study demonstrates long-term cost effectiveness of machine perfusion versus static cold storage 



Lifeline Scientific, the medical technology company focused on commercialising its LifePort® Kidney  Transporter,  announces the presentation of further data supporting the advantages of it's machine perfusion device over the standard practice of static storage using ice in a cool box.  The data was presented last week at the American Transplant Congress in BostonUS.


The results demonstrate that kidneys from non-heart beating donors (NHBD) and from donors older than 65 years have a reduced risk of delayed graft function when preserved with the LifePort than kidneys stored in a cool box. Non-heart beating and older donors represent a significant potential new resource to help solve the global shortage of donor organs for transplant.  A transplant patient who receives a kidney that does not work immediately will need to receive post-transplant dialysis treatment.  In older donor kidneys, the risk of primary non function is four time less likely in kidneys that are LifePorted as compared to the box of ice.  


Another study demonstrated the long term cost-effectiveness of LifePort machine perfusion compared with static cold storage in kidney transportation.


Highlights of the Results

 

·      Machine perfusion of non-heart beating donor kidneys reduces incidence, duration and severity of delayed graft function after kidney transplantation.
·       Kidneys of donors older than 65 years show a clear advantage when preserved in the LifePort, especially in case of delayed graft function.
·       Cost-effectiveness and cost-utility ratios suggest that life years and quality adjusted life years can be gained while  reducing cost at the same time.

 

In January of this year, landmark trial results published in the New England Journal of Medicine showed that for transplanted kidneys preserved and transported in Lifeline's LifePort Kidney Transporter, the odds of experiencing a delay in recovery of kidney function are 43% lower, and that these kidneys are 48% less likely to fail within a year compared to those stored in the traditional box of ice.


David Kravitz, Chief Executive of Lifeline Scientific, said:'These results are yet further evidence of the clear advantages of LifePort machine perfusion over traditional static ice box storage. The mounting body of evidence in support of the clinical benefits and cost-effectiveness of our machine perfusion technology over traditional cold storage methods underlines the potential for LifePort to be an important new tool for transplant medicine. We look forward to accelerating the full commercial rollout of LifePort this year.'  


Enquiries

 

Lifeline Scientific, Inc.


David Kravitz, CEO


Seymour Pierce (Nomad)

+44 (0)20 7107 8000

Mark Percy / Huaizheng Peng / Sarah Jacobs


Financial Dynamics

+44 (0)20 7831 3113

Ben Brewerton / John Dineen

 

 

Detailed Results


1. Machine perfusion versus cold storage preservation in non-heart-beating kidney donation and transplantation

This analysis of the Machine Preservation Trial compared outcomes in 82 pairs of kidney from non heart-beating-donors, which were assigned to either machine preservation (MP) with the LifePort or to conventional cold storage (CS). All 164 recipients were followed up at three months post transplantation. Statistically significant results showed that delayed graft function (DGF) was strongly reduced. (Duration of DGF [days] was 9 in MP vs. 13 in CS, p=0.05. DGF < 7 days occurred in 27% in the MP vs. 10.5% in the CS arm, p=0.028).


2. Machine perfusion versus cold storage in transplantation of kidneys from older deceased donors: results of a prospective randomized multicentre trial

A second analysis compared 118 pairs of kidneys from donors 55 years old and older which were randomly assigned to either machine preservation or cold storage. All 236 recipients were followed up at 6 months.  Although this trial utilised expanded criteria organs and DGF did occur in both MP and CS group ( with the incidence of DGF 22% in MP vs. 31.4 % in CS recipients, p=0.07), the trial demonstrated that the function of MP kidneys recovered faster that those in the CS group (DGF <7 days occurred in 10 recipients in the MP vs. 5 in the CS arm, p=0.02). When DGF occurred six month graft survival was significantly better in kidneys preserved with MP than by CS: 84% vs. 60%, p=0.026.


In addition this trial demonstrated statistically significant results in favour of MP in respect of primary non function (2.5% in MP vs. 10.2% in CS kidney recipients, p=0.015). 

 

About the Machine Preservation Trial

The Machine Preservation Trial is the first prospective, statistically powered, randomized, controlled, multicentre trial to investigate the efficacy, cost effectiveness and practicalities of continuous hypothermic machine perfusion from donor to recipient versus static storage in deceased donor kidneys. The trial lasted for two years.


The Machine Preservation Trial was conducted in collaboration with Eurotransplant and the Deutsche Stiftung Organtransplantation ('DSO'). Since 1 November 2005, all cadaveric kidney donors over 16 years of age from Belgium, The Netherlands, and the DSO Region Nordrhein-Westfalen Germany were considered for enrollment in the trial. The trial was sponsored by Organ Recovery Systems, an operating business of Lifeline Scientific.


The trial compared outcomes in 336 pairs of kidneys, one preserved with machine preservation on the LifePort and the other by static ice box storage.


About the LifePort Kidney Transporter

Created with the challenges of organ recovery and transport in mind, LifePort Kidney Transporter is designed to provide improved kidney preservation, evaluation and transport prior to transplantation. LifePort provides a sealed, sterile, protected environment where a solution is gently pumped through the kidney at cold temperatures to minimize damage while the organ is outside the body. LifePort is lightweight and portable, allowing organs to be perfused from the time of recovery until transplant. It is designed to travel unaccompanied by land or air, safely transporting the kidneys across town or between countries. While the kidney is being perfused, the LifePort records data on temperature, flow rate, vascular resistance and pressure every 10 seconds providing surgeons with additional data prior to transplant. During its pilot introduction, over 300 LifePorts have been installed in 90 transplant programmes worldwide treating more than 17,000 kidneys for clinical transplant.  


About Lifeline Scientific Inc.  

Lifeline Scientific, Inc. is a Chicago-based global medical technology company with European headquarters located in Brussels. Its primary focus is to commercialise its FDA approved, CE marked, clinically validated and revenue generating LifePort Kidney Transporter. Devices for preservation of the heart, lung, pancreas and liver are in late stage pre-clinical development.



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