Deltex Medical Regulatory News (DEMG)

Deltex Medical Group plc

Final NICE guidance recommends CardioQ-ODM™

30 March 2011 - Deltex Medical Group plc ("Deltex Medical" or the "Company"), the global leader in oesophageal Doppler monitoring ("ODM"), announces that the National Institute for Health and Clinical Excellence ("NICE") has today published final guidance recommending the Company's CardioQ-ODM system.

NICE issued preliminary guidance on Deltex Medical's CardioQ-ODM in October 2010. Following public consultation the breadth of NICE's recommendation has been increased to cover "patients undergoing major or high-risk surgery or other surgical patients in whom a clinician would consider using invasive cardiovascular monitoring".

In its guidance on implementation by the NHS, NICE estimates that its recommendation applies to 837,000 surgical patients each year in the NHS in England alone. Across the UK as a whole, using NICE's estimated average saving per patient of £1,100 per hospital stay, this represents a potential £1 billion annualised saving.

NICE's guidance is at guidance.nice.org.uk/MTG3 and the final guidance states:

"1.1 The case for adopting the CardioQ-ODM in the NHS, when used as described in 1.2, is supported by the evidence. There is a reduction in post-operative complications, use of central venous catheters and in-hospital stay (with no increase in the rate of re-admission or repeat surgery) compared with conventional clinical assessment with or without invasive cardiovascular monitoring. The cost saving per patient, when the CardioQ-ODM is used instead of a central venous catheter in the peri-operative period, is about £1100 based on a 7.5-day hospital stay.

1.2 The CardioQ-ODM should be considered for use in patients undergoing major or high-risk surgery or other surgical patients in whom a clinician would consider using invasive cardiovascular monitoring."

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

"NICE's final guidance is a resounding endorsement for the CardioQ-ODM at a time when the NHS is charged with delivering £20 billion of efficiency savings over the next four years. Implementing this guidance in full would be a significant step towards the NHS delivering these savings while improving considerably the care given to those patients undergoing major and high risk surgery.

"The NICE guidance follows on from the 'How to, Why to' guide published in 2010 by the NHS National Technology Adoption Centre setting out 'real world' lessons on how to implement effectively the CardioQ-ODM into routine practice in NHS hospitals."

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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 2,300 CardioQ-ODMscurrently 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-ODMagainst known standards for measuring cardiac output

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

·; Proved that CardioQ-ODMdelivers 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-ODMin a similar format and is used for taking snapshots or monitoring over short periods.