Deltex Medical Regulatory News (DEMG)

Deltex Medical Group plc

Deltex Medical awarded NHS Supply Chain tender and launches new CardioQ-ODM+ monitor for intensive care market

7 March 2012 - Deltex Medical Group plc, the global leader in oesophageal Doppler monitoring ("ODM"), announces that, following a tender process, it is one of the companies selected to sell cardiac output monitoring equipment to the NHS in England through NHS Supply Chain under a framework agreement that commences this week.

To coincide with the award of this tender, Deltex Medical also announces that it has launched a new monitor, the CardioQ-ODM+™, the first haemodynamic monitor in the world to combine Doppler measurement of blood flows with Pulse Pressure Waveform Analysis ('PPWA'). Both the CardioQ-ODM and the CardioQ-ODM+ are now available to NHS hospitals through NHS Supply Chain together with Deltex Medical's full range of single patient disposable ultrasound probes.

NHS hospitals are, for the first time, able to purchase Deltex Medical's products from NHS Supply Chain rather than go through a separate tendering process under European Union procurement regulations. The NHS Supply Chain framework agreement covers an initial period of two years, followed by the opportunity to extend for up to a further two years.

The CardioQ-ODM+ is a premium version of the proven CardioQ-ODM™. The CardioQ-ODM+ is an oesophageal Doppler monitor (ODM) which also supports arterial pressure measurement and analysis of the waveform generated in those patients with an arterial line in place.

CardioQ-ODM+ is primarily targeted at applications in intensive care where continuous monitoring can be important. In surgery it is less likely that PPWA will supplement usefully the ODM data and its application is limited to circa 10% of the target patients for CardioQ-ODM.

Ewan Phillips, Deltex Medical's chief executive, commented:

"We are delighted that we are now able to sell our products through NHS Supply Chain. We believe that this will accelerate the procurement process in many NHS hospitals as the NHS pursues its decision to implement fully ODM or similar fluid management monitoring technologies during surgery.

"The CardioQ-ODM+ offers clinicians the most complete haemodynamic monitoring solution available today. ODM is the best intervention tool thanks to its precision, ease of use and ability to detect small changes in flow in the central vascular system. PPWA is better suited to monitoring than to intervention and the addition of ODM should overcome several of PPWA's practical limitations."

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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-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.