Deltex Medical Regulatory News (DEMG)

Deltex Medical Group plc

Details published of NHS South plan to implement ODM

23 October 2012 - Deltex Medical Group plc, the global leader in oesophageal Doppler monitoring ("ODM"), notes that NHS South of England has published its "Innovation Health and Wealth: Innovation Plan" which includes targets for the implementation of national high impact innovations.

The plan sets out local targets for CQUIN (Commissioning for Quality and Innovation) incentive payments for each of the six high impact innovations specified in December 2011's Innovation: Health and Wealth report, one of which was to launch a drive to implement fully "ODM or similar fluid management monitoring technologies" across the NHS.

The NHS South of England targets for fluid management are expressed in terms of numbers of patients a year treated per 100,000 of population and the targets set are:

·; 150 patients per 100,000 in February and March 2013

·; 200 patients per 100,000 in the NHS financial year starting 1 April 2013

·; 250 patients per 100,000 in the NHS financial year starting 1 April 2014

·; 400 patients per 100,000 in the NHS financial year starting 1 April 2015

In the year ended 31 December 2011, CardioQ-ODM was used during surgery on circa 50 patients a year per 100,000 of population in NHS South of England and the Directors of Deltex Medical believe that CardioQ-ODM is by some way the market leading fluid management monitor in surgery in the region.

NHS South of England covers a population of over 13 million, just over a quarter of the population of England. It estimates that 53,789 surgical patients would be treated with intra-operative fluid management technologies in 2015/16 in the South of England, approximately 25% of the 220,000 who would be treated with 100% compliance with the NICE (National Institute for Health and Clinical Excellence) guidance on CardioQ-ODM.

The plan notes that its regional targets for adoption of intra-operative fluid management may "be updated following completion of national work on pre-qualification requirements for CQUIN".

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

"Successful implementation of the NHS South of England plan will cause a step change in the market for intra-operative fluid management monitoring in the region in the next two and a half years, with clear potential for either faster or further growth to address the remaining three-quarters of patients where NICE already recommend CardioQ-ODM usage.

"CardioQ-ODM has a strong market leadership position in the NHS, is the most widely applicable technology available for major surgery, is the only technology recommended by NICE and is the only technology with an evidence base that shows both improved outcomes for patients and reduced lengths of hospital stay which are the benefits being pursued by the NHS."

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

Deborah Walter dwalter@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.