Deltex Medical Regulatory News (DEMG)

Deltex Medical Group plc

Enhanced recovery update

19 October 2012 - Deltex Medical Group plc, the global leader in oesophageal Doppler monitoring ("ODM"), announces further progress in establishing ODM as a key element of enhanced recovery programmes for major surgery.

At the inauguralERAS Congress in Cannes, France, 250 doctors from around the world met to discuss the content, implementation and clinical effectiveness of enhanced recovery. The importance of fluid management during surgery and ODM were recurring themes highlighted by speakers.

The Enhanced Recovery After Surgery ('ERAS') academic society has been expanded to include surgeons and anaesthetists from Sweden, the Netherlands, Norway, UK, Spain, Germany, Canada and USA. In a further endorsement of ODM, ERAS has this month published clinical guidelines for rectal and pelvic surgery1 which include a "strong" recommendation in respect of fluid management:

"Fluid balance should be optimised by targeting cardiac output and avoiding overhydration. Judicious use of vasopressors is recommended with arterial hypotension. Targeted fluid therapy using the oesophageal Doppler system is recommended."

In a further development, doctors from Duke University in North Carolina, who are members of ERAS, were amongst speakers at a reception on the subject of enhanced recovery held at the British Embassy at Washington DC, which coincided with the annual meeting of the American Society of Anesthesiologists. The 100 guests included healthcare policy makers and providers as well as doctors from leading US hospitals. The presentations covered progress with the UK NHS roll-out of enhanced recovery across all major surgical disciplines as well as a report on Duke's initial experience within colorectal surgery. The Duke programme evidenced significant enhancements, including fewer post operative complications, increased patient satisfaction, a 40% reduction in hospital stay and estimated cost savings to the hospital of over 20%.

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

"There is considerable momentum behind the spread of enhanced recovery as standard of care for all major surgery in Europe, as well as growing recognition of the opportunity to improve significantly surgical care through its adoption in North America. ERAS is well positioned to set global clinical standards for enhanced recovery and it is encouraging that their recommendations highlight specifically ODM technology. ODM is unique amongst intra-operative fluid management monitoring technologies in having a substantial evidence base demonstrating its benefits."

1 Guidelines for Perioperative Care in Elective Rectal/Pelvic Surgery: Enhanced Recovery After Surgery (ERAS) Society Recommendations. J Nygren, J Thacker, F Carli, KCH. Fearon,S Norderval,DN Lobo,O Ljungqvist, M Soop, J Ramirez. World Journal of Surgery October 2012

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.