Interim Trial Results

RNS Number : 7957X

Deltex Medical Group PLC

30 June 2008

 



Deltex Medical Group plc

Early results presented from major trial using CardioQ-ODM™ in urological surgery

30 June 2008 - Deltex Medical Group plc ('Deltex Medical' or 'the Company'), the UK's leading haemodynamic monitoring company, today announces the first presentation of early results from a significant new clinical trial using the CardioQ-ODM in major bladder surgery.

In a presentation to the annual meeting of the British Association of Urological Surgeons in Manchester, doctors from the Freeman Hospital in Newcastle-upon-Tyne set out the results of the pilot phase of their blinded prospective randomised controlled trial on ODM-guided fluid management during major urological surgery. The results cover the first 40 patients enrolled into the study and are therefore not yet statistically significant. However, they indicate results consistent with previous trials in other types of surgery including reduced post-operative complications and reduced lengths of hospital stay.

The full study is designed to include over 100 patients and the doctors expect it to take at least another 18 months to complete, although further interim results may become available sooner.

Andy Hill, Deltex Medical's Chief Executive commented:

'We are excited that the promising results of the pilot phase of this trial are already being presented to a major meeting of specialist urological surgeons and have started to plan for specifically targeting this group over the medium term as more results come through.

The Freeman Hospital's earlier trial into using CardioQ-ODM in bowel surgery has had a positive impact in all our target markets with a growing number of hospitals in the UK and Europe protocolising the use of the CardioQ-ODM in their standard operating procedures. In the event that the full study bears out the preliminary results of the pilot phase we would expect this trial to have a similar positive impact.'

For further information, please contact:

Deltex Medical Group plc             01243 774 837

Nigel Keen, Chairman                      [e-mail]

Andy Hill, Chief Executive                [e-mail]

Ewan Phillips, Finance Director        [e-mail] 

Gavin Anderson & Company         020 7554 1400

Deborah Walter                              [e-mail]

Robert Speed                                 [e-mail]

Charles Stanley Securities            020 7149 6000

(Nominated Adviser)

Philip Davies                                  [e-mail] 

Russell Cook                                 [e-mail] 

  Notes for Editors

Deltex Medical manufactures and markets the CardioQ-ODM™ monitor, which uses disposable ultra-sound probes inserted into the oesophagus to determine the amount of blood being pumped around the body - 'circulating blood volume'. Reduced circulating blood volume is known as hypovolaemia, which leads to insufficient oxygen being delivered to the organs. This causes medical complications including peripheral and major organ failure which can lead to death. Hypovolaemia, which is akin to severe dehydration, affects virtually every patient having surgery because of the combined effects of pre-operative starvation, the impact of the anaesthetic agents and trauma from the surgery itself. Using fluids and drugs, guided by the CardioQ-ODM, to optimise the amount of circulating blood significantly reduces post-operative complications allowing patients to make a faster, more complete recovery and return home earlier.

The CardioQ-ODM incorporates the Company's proprietary software and a small diameter, easy-to-use, minimally invasive, disposable oesophageal probe that is used for transmitting and receiving an ultra-sound signal. By using this technology, the CardioQ-ODM provides clinicians with the ability to haemodynamically optimise critically ill patients and those undergoing routine moderate to major surgery through the controlled administration of fluid and drugs. Haemodynamic optimisation has been scientifically proven to improve the speed and quality of patient recovery and reduce hospital stay.

There are already over 1,500 CardioQ-ODMs currently in use in hospitals worldwide and distribution arrangements are in place in over 30 countries. In addition, there are currently more than 100 clinical publications on the use of the CardioQ-ODM which have repeatedly:-

• Validated the results of the Monitor against known standards for measuring cardiac output, demonstrating that the technology works
  
• Proved that the CardioQ-ODM works in a wide range of surgical procedures
  

• Demonstrated that the Company's technology provides significant health and economic benefits by helping to reduce post-operative complications and length of hospital stays by an average of 30 to 40 per cent for a wide range of patients.

The SupraQ™ is an entirely non-invasive device which uses an ultrasound probe held at the base of the patient's neck to track the flow of blood in the aorta; it presents the same data as the CardioQ-ODM in a similar format and is used for taking snapshots or monitoring over short periods.

 

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