Lifeline Scientific Release: Trial Results Published and Trading Update

Published: Jan 05, 2009

Lifeline Scientific, the medical technology company focused on commercialising its LifePort® Kidney Transporter, announces the publication of landmark trial results in a leading medical journal and gives a trading update. LifePort® (marketed through the Company’s Organ Recovery Systems division) is an advanced organ preservation and transport system designed to address the global challenge of human donor organ shortages.

Results from Landmark Trial

The New England Journal of Medicine has published the results of a landmark trial, reflecting its importance as the first large scale randomised, prospective trial to compare the preservation of kidneys for transplant via LifePort® Kidney Transporter with the traditional box of ice.

The trial showed that for transplanted kidneys preserved and transported in the 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. In short, the study showed that kidneys for transplant function earlier and last longer when preserved in the LifePort compared to the traditional box of ice.

Depending on the type of deceased donor, 15% - 50% of transplanted kidneys do not function immediately following transplantation and many patients will require dialysis treatments for a certain period after transplantation. As a result, these kidneys have an increased risk of rejection and survival of the kidney graft may be compromised. This in turn will not only increase hospitalisation of the patient and therefore the cost, but also put pressure on the already long transplant waiting lists.

Trading Update

Lifeline has continued to experience strong growth in the second half. Revenue for the 12 months ended 31 December 2008 will be ahead of market expectations. EBITDA loss will be lower than expected and materially lower than for the year ended 31 December 2007.

The Company expects to announce preliminary results for the period in March 2009.

David Kravitz, Chief Executive of Lifeline, said:

“Evidence from the first scientific clinical trial of this kind demonstrates clearly that using LifePort can help increase the quality and quantity of kidneys available for transplantation, improve outcomes for kidney transplant patients and reduce the overall cost of kidney transplants.

“Publication of the trial results by the New England Journal of Medicine underlines the potential for LifePort to be an important new tool for transplant medicine. The published results will allow us to accelerate the full commercial roll out in 2009 when we expect to see solid growth and the potential for LifePort to become a new standard of care for most types of cadaveric kidney preservation.”

Jacques Pirenne, principal investigator and Professor of Surgery at the Department of Abdominal Transplant Surgery – Transplant Coordination at the University Hospitals Leuven, Belgium, said:

“This is a truly important finding for the thousands of people on transplant waiting lists around the world.

“This trial shows unequivocally that kidneys preserved by machine perfusion function better and last longer and this will translate into a better quality of life for our transplant patients. With this technology we now hope to enlarge the donor pool by using kidneys that we did not use in the past because we could not preserve them adequately.”

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, approximately 280 LifePorts have been installed in 81 transplant programmes worldwide treating more than 12,000 kidneys.

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.

Facts about the trial

The Machine Preservation Trial was an investigator-driven study, run by an independent scientific steering committee across The Netherlands, Belgium and the German federal state of North Rhine Westphalia, in close collaboration with Eurotransplant International Foundation (the international organ exchange organisation for Austria, Belgium, Croatia, Germany, Luxemburg, The Netherlands and Slovenia) as the central trial assistance desk. Principal investigators were Rutger Ploeg (Groningen, The Netherlands), Andreas Paul (Essen, Germany), and Jacques Pirenne (Leuven, Belgium).

During the time of the trial, every deceased donor in the area was considered for inclusion in the study. 336 pairs of kidneys were enrolled in the study. One kidney from each pair was randomly assigned to machine preservation, and the other one to cold storage. Kidneys were transplanted in recipients across the Eurotransplant area.

The manufacturers, Organ Recovery Systems of Chicago, USA provided the LifePort Kidney Transporters used in the study. The machines were used for the preservation and transport of kidneys from organ recovery until transplantation.

Study Endpoints

The primary endpoint was delayed graft function defined as the need for dialysis in the first week post transplantation. Evidence suggests that organs that do not function immediately after transplantation have an increased risk of rejection and survival of the transplanted kidney may be inferior.

Secondary endpoints included: patient and graft survival up to 12 months after transplantation, duration of delayed graft function, length of stay in hospital, primary non-function of the transplanted kidney, serum creatinine and clearance after transplantation, acute rejection and calcineurin inhibitor toxicity.

Results from the study

Machine perfusion significantly reduced the risk of delayed graft function compared to cold storage. 70 out of 336 kidney recipients in the machine perfusion group developed delayed graft function compared with 89 out of 336 patients in the cold storage group (adjusted odds ratio 0.57; P=0.01).

In case delayed graft function occurred, its duration was shorter after machine perfusion compared with cold storage (10 days vs. 13 days; P=0.03).

One year graft survival was superior in the machine perfusion group (94% vs. 90%; P=0.04) and machine perfusion was associated with a reduced risk of graft failure in the first year post-transplant (hazard ratio 0.52; P=0.03).

Serum creatinine values were significantly lower for machine perfused kidney recipients compared to those cold stored in the first two weeks post transplantation (P=0.01).

There were no significant differences observed for the other secondary endpoints.

No serious adverse events were directly attributable to machine perfusion.

Facts about transplantation

More than 1.5 million people worldwide suffer from end stage renal disease.

In the USA alone, for example, there are currently 82,435 people waiting for a kidney transplant. To date this year 4,213 kidneys have been recovered from deceased donors.

Eurotransplant International Foundation (Eurotransplant) is the international organ exchange organisation for Austria, Belgium, Croatia, Germany, Luxemburg, The Netherlands and Slovenia and serves a population of 118 million.

In the Eurotransplant area there are currently 10,719 people waiting for a kidney transplant (active waiting list of September 30, 2008).

In 2007, 3,420 people received a kidney transplant in the Eurotransplant region.

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