Deltex Medical Regulatory News (DEMG)

Deltex Medical Group plc

NHS Innovation Review prioritises ODM for 2012/2013 NHS financial year

6 December 2011 - Deltex Medical Group plc, the global leader in oesophageal Doppler monitoring ("ODM"), announces that the NHS Chief Executive has published his intention to instruct the NHS to implement fluid management during surgery using ODM as a priority.

The NHS Chief Executive's review of innovation in the NHS commits the NHS to implement ODM guided fluid management during surgery.

The report states:

"ODM is a minimally invasive technology used by anaesthetists during surgery to assess the fluid status of the patient and guide the safe administration of fluids and drugs. In March 2011, NICE published guidance on the use of ODM, recommending it for patients undergoing major or high-risk surgery and certain other surgical patients. Despite a comprehensive evidence base, uptake of this technology has been poor across the NHS. Full adoption of this technology across the NHS is forecast by NICE to benefit over 800,000 patients and generate net financial savings of over £400m. Current information suggests that these technologies are used for less than 10% of applicable patients.

"We will launch a national drive to get full implementation of ODM, or similar fluid management monitoring technology, into practice across the NHS."

CardioQ-ODM is the only fluid management technology recommended by NICE in its guidance of 30 March 2011.

Implementation of ODM fluid management is one of a small group of high impact innovations where the NHS "will make an immediate start" on implementation. This intention is supported by a significant financial incentive: NHS organisations are required to comply with these high impact innovations by April 2013 otherwise they will fail to pre-qualify for the CQUIN payment scheme which is worth 2.5% of NHS organisations revenues.

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

"This important announcement by the NHS should mark the end of the market creation phase in the UK for our leading product, the CardioQ-ODM™, heralding the start of the accelerated growth phase for Deltex Medical.

"The same robust evidence base that underpinned NICE's wide-ranging recommendation of CardioQ-ODM has enabled the NHS now to insist that hospitals implement best practice fluid management during surgery1."

1 See 'Fluid management evidence base' section at http://www.deltexmedical.com/ 

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

Jamie Cameron jamie.cameron@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 2,300 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.