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Clinical Study Data

29 Mar 2007 07:00

For immediate release 29 March 2007 LiDCO Group Plc ('the Company')

Further clinical outcome studies using the LiDCOplus Monitor - reductions in mortality, complications and length of stay

LiDCO, the UK based, AIM-quoted cardiovascular monitoring company, announces that this week's International Society of Intensive Care and Emergency Medicine meeting in Brussels includes two presentations on the impact of the use of the LiDCOplus Monitor on clinical outcomes in both high-risk surgery patients and patients admitted to intensive care for treatment for shock.

These results show that use of LiDCO's technology:

* In high-risk surgery patients reduces hospital length of stay by over 50% (13 to 6 days) and reduces mortality from 27% to 6%. * Reduces the mortality rate of patients in shock treated in intensive care (32% to 12%), when compared to patients treated with the older more traditional invasive technology (pulmonary artery catheter).

Background: Previous findings on the use of LiDCO's technology in high-risk surgery patients, have shown that achieving and maintaining increased oxygen delivery, immediately after major surgery significantly reduces the patients' risk of post-operative complications by more than one third and also reduces the length of time spent in hospital by an average of 12 days (St George's Hospital, London study). Implementation of a similar strategy in other hospitals across the NHS could result in estimated savings of ‚£500 million annually. LiDCO's minimally invasive technology provides real-time measurement of the absolute level of oxygen delivery without the need for insertion of an invasive catheter into a major artery or the heart.

The studies:

LiDCO shock patient study - Division of Critical Care, University of Iowa Hospitals and Clinics, Iowa City, USA. Principal investigator: Professor Steve Hata.

The University of Iowa have been using the LiDCO technology since 2003. In 2006 a retrospective analysis of the outcome of a severely ill group of patients who had been treated for septic shock and systemic inflammatory response syndrome (SIRS) was conducted. This epidemiological study was undertaken to see what impact, if any, the various hemodynamic monitoring technologies used in this intensive care unit were having on improving outcome in this gravely ill patient population.

The optimal way to monitor the resuscitation of septic shock and SIRS patients is still not known - but hemodynamic monitoring is thought to be of importance. In this study the outcome of 256 patients who were admitted to the intensive care unit between 2003 and 2006 with a diagnosis of shock or SIRS was investigated. The investigators wanted to evaluate whether the mortality rate and clinical outcome was influenced by the choice of hemodynamic monitoring used to treat these severely ill patients. This study showed that patients treated with the LiDCOplus Monitor had a lower mortality rate than those treated clinically with an invasive catheter-based technology - the pulmonary artery catheter. ICU mortality in the LiDCO treated group of patients was 12% compared to 32% in the pulmonary artery catheter treated group or 31% in those patients managed without hemodynamic monitoring.

The data from this center supports the idea that a process of care involving the LiDCOplus monitor decreases death rates in patients with septic shock or SIRS. LiDCO sensor technology has been designed to be less invasive, more real-time, and quick to set up; the LiDCOplus monitor interfaces with the user through "at a glance" screens which are therefore easier to interpret. Given these advantages it is likely that LiDCOplus -guided resuscitation improves the efficiency and/or timing of the resuscitation process and that it is this accelerated process and change of care that is associated with the mortality reduction.

Professor Steve Hata stated: "We were impressed by the difference in both mortality and length of stay among the various monitors. This is an important finding which deserves further study. Since the introduction of LiDCO, the number of patients monitored has increased due to its less invasive nature while the rate of pulmonary artery catheter usage has reduced."

LiDCO surgery patients study: Division of Critical Care, Faculdade de Medicina de sģo Josĩ do Rio Preto, Brazil. Principal investigator: Dr Susan Lobo.

A Faculty of Medicine in Brazil investigated whether use of the LiDCO technology could reproduce, or even improve on, the results already seen with use in high-risk surgical patients. This study's unique feature was that LiDCO's technology was used during the surgery itself, as well as for 8 hours post operatively. The additional surgical use was undertaken in order to see if the excellent results seen in the previous UK St George's study could be taken one step further by intervention earlier to generate a reduction in patient mortality as well as complications and length of stay.

In brief, this study reviewed the use of an early goal directed therapy (EGDT) approach using the LiDCOplus Monitor in 34 high-risk surgery patients. Patients' oxygen delivery was maintained at target levels both during surgery and post-operatively for 8 hours. The study evaluated if such an approach was a feasible and practical way to guide oxygen delivery optimization therapy in high-risk patients and if this approach resulted in a significantly lower mortality rate, hospital stay and complications. This study demonstrated that LiDCOplus monitor mediated EGDT reduced hospital length of stay by half (6 days versus 13) in the control group and mortality - only 2 patients (6%) dying against 7 (27%) in the non treated historical controls. Complications in the EGDT treated patients were also halved.

Dr Susan Lobo stated that: "The use of a therapeutic approach guided by oxygen delivery calculated by the LiDCOplus Monitor, intra-operatively and post-operatively, is a feasible and practical approach to guide oxygen delivery optimization therapy during major surgeries in high-risk patients. Better perfusion of vital organs resulting in a much lower rate of complications, mortality and duration of hospital stay were seen in the optimized patients."

Dr Terry O'Brien stated that: "It is tremendous to see American based centers showing, as already demonstrated in the UK, that use of our accurate and minimally invasive monitoring product will produce considerable clinical and cost benefits for the patient and hospital. We would like to thank these two centers for all their hard work to show the wider clinical community that the benefits of hemodynamic monitoring clearly outweigh the investment required to adopt this approach."

- ENDS -

For more information please contact:

LiDCO Group Plc Tel: +44 (0)20 7749 1500

Terry O'Brien - Chief Executive

Buchanan Communications Tel: +44 (0)20 7466 5000

Tim Anderson, James Strong

Notes for Editors

Septic shock: The process of infection can result in systemic signs and symptoms that are variously described as septic shock. This is a serious medical condition that causes an inflammatory state in response to an infection that despite treatment can result in multi organ failure and death. The mortality rate from septic shock can be as high as 50%.

Systemic inflammatory response syndrome (SIRS) is an inflammatory state of the whole body without a proven source of infection. It is also a serious medical condition that can result in the death of the patient.

About LiDCO Group Plc

LiDCO is a UK-based AIM-traded developer, manufacturer and leading supplier of minimally invasive, computer-based hemodynamic monitoring equipment and disposables used primarily for the management of critical care and cardiovascular risk hospital patients. Use of LiDCO's technology has been shown to significantly reduce the complications (particularly infections) and costs associated with major surgery. The technology was invented in the Department of Applied Physiology based at St Thomas' Hospital, London.

The Company's manufacturing facility is in Hoxton, London and its current products are:

* LiDCOplus and PulseCO monitors: computer-based platforms for displaying a range of real-time, continuous hemodynamic parameters including cardiac output, oxygen delivery and fluid volume;

* LiDCO disposables: used in conjunction with the LiDCOplus Monitor to accurately determine cardiac output in a minimally-invasive manner.

* LiDCOview - software product for use on a PC: designed to aide clinical audit, teaching and research activities.

Distribution Network:

The Company has now achieved registration of its products in 14 markets in Europe, the USA, Brazil and Japan. It sells direct in the UK and USA, and elsewhere through a worldwide network of specialty critical care distributors.

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