Deltex Medical Regulatory News (DEMG)

Deltex Medical Group plc

New study reinforces CardioQ-ODM's competitive advantage

29 November 2012 - Deltex Medical Group plc, the global leader in oesophageal Doppler monitoring ("ODM"), notes the publication of a new clinical study which shows the substantial technological advantages of ODM over a competing technology.

Doctors from the Karolinska Institute in Sweden found the uncalibrated Pulse Pressure Waveform Analysis (PPWA) system used in the study to be unable to replicate accurately measurements from the CardioQ-ODM during major surgery1.

The proven clinical and economic benefits of ODM derive from its ability to detect reliably small (10%) changes in the amount of blood pumped around the body with each heartbeat (Stroke Volume or 'SV'). The study found that the ability of the PPWA device to measure similar small (10%) changes in blood flow in response to fluid challenges was poor. Overall, PPWA could only 'see' small (10%) increases in 48% of the patients in the trial, critically, this was reduced to only 11% of the patients whose blood pressure decreased or remained the same after the fluid was administered. The authors also tested and found unhelpful the PPWA derived parameters Stroke Volume Variation ('SVV') and Pulse Pressure Variation ('PPV') claimed to detect fluid deficits in ventilated patients.

The authors concluded:

"LIDCO Rapid and ODM devices are not interchangeable. We cannot recommend that the LIDCO Rapid replace the standard Doppler method until further device-specific outcome studies on volume optimization are available. The dynamic indices SVV and PPV add little value to a fluid optimization protocol during conventional ventilation parameters, and should not replace SV measurements with a validated technique."

1. http://bja.oxfordjournals.org/content/early/2012/11/20/bja.aes399.abstract

Ewan Phillips, Deltex Medical's Chief Executive, commented:

"The UK Department of Health has informed us that it intends to publish, before Christmas, details of the targets and financial incentives for the first phase of its national drive to get full implementation of ODM or similar fluid management monitoring technology into practice across the NHS. This independent study from one of Europe's leading teaching hospitals is very timely. It addresses any misconception that the device used in this study could be considered similar to ODM in the demanding environment of major surgery.

"ODM is the only fluid management monitoring technology proven to deliver the improved outcomes sought across the NHS and only CardioQ-ODM has been evaluated and recommended by the National Institute of Health and Clinical Excellence (NICE) for use by clinicians for intra operative fluid management."

For further information, please contact:-

Deltex Medical Group plc 01243 774 837

Nigel Keen, Chairman njk@deltexmedical.com

Ewan Phillips, Chief Executive eap@deltexmedical.com

Paul Mitchell, Finance Director pjm@deltexmedical.com

Nominated Adviser & Broker

Arden Partners plc 020 7614 5900

Chris Hardie chris.hardie@arden-partners.com

Kreab Gavin Anderson 020 7074 1800

Robert Speed rspeed@kreabgavinanderson.com

Notes for Editors

Deltex Medical manufactures and markets the CardioQ-ODMÔ system. CardioQ-ODM changes the way doctors care for surgical patients allowing them to recover faster and leave hospital sooner and in better health than they otherwise would do. The performance of the system has been validated through independently conducted, randomised controlled clinical trials and is being translated into routine clinical practice in leading hospitals around the world.

CardioQ-ODM comprises a monitor and a single patient disposable probe. The probe is placed into the oesophagus through either the mouth or nose and the tip positioned facing the adjacent descending aorta. A low frequency ultrasound signal, generated by the monitor, is bounced off the blood travelling down the aorta and the Doppler principle is used to determine the velocity of the blood flow, expressed in distance per cardiac cycle - 'Stroke Distance'. The monitor also calculates the amount of time that blood is flowing down the aorta as a proportion of a cardiac cycle - 'Flow Time'.

The monitor uses a validated proprietary nomogram to extrapolate volumetric data (Stroke Volume, Cardiac Output etc) from the directly measured flow velocity. The nomogram utilises the patient's age weight and height, effectively to estimate the size of the aorta in which the velocity of the flow is being measured. Crucially this means that any reported relative change in Stroke Volume is absolutely identical to the relative change in the directly measured flow velocity variable of Stroke Distance. CardioQ-ODM immediately and reliably identifies even very small changes in the blood flow velocity allowing doctors to intevene earlier and on smaller changes than with any other approach.

Intra-operative individualised Doppler guided fluid management entails insertion and focusing of the probe to obtain a baseline reading, giving a small (200 to 250 ml) fluid challenge directly into the vascular system and seeing if Stroke Volume (or Stroke Distance) increases by more than 10%. If the increase is more than 10%, repeat fluid boluses are administered until such time as the increase is less than 10%: after this no further fluid is given unless Stroke Volume falls by more than 10% - the process is designed to achieve and maintain the individual patient's optimal Stroke Volume. CardioQ-ODM is also used during surgery to guide administration of vaso-active agents such as inotropes.

The CardioQ-ODM helps patients by enabling doctors to reduce the complications that arise from a medical condition that is common to almost all patients having surgery and many others in intensive care or arriving in the accident and emergency department. This condition is known as hypovolaemia - a reduction in circulating blood volume - and in surgical patients arises as a direct consequence of the combined effects of pre-operative starvation, the anaesthetic agents and the blood and fluid losses associated with the surgical procedure itself. Hypovolaemia means that the body struggles to get sufficient blood to the tissues and vital organs which are consequently starved of essential oxygen. This can cause medical complications including peripheral and major organ failure, which if not dealt with quickly can lead to severe compromise or even death.

There are already over 2,500 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 250 clinical publications on the use of the CardioQ-ODM which have repeatedly:-

·; Validated the results of CardioQ-ODM against known standards for measuring cardiac output

·; Proved that CardioQ-ODM works in a wide range of surgical procedures

·; Proved that CardioQ-ODM delivers 50% or more reductions in post-operative complications and 25% or more reductions in length of hospital stay: better care at lower cost.

The SupraQÔis 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.