Deltex Medical Regulatory News (DEMG)

12 Feb 2009 12:27



12 February 2009 Deltex Medical Group plc

UK's National Institute for Health Research ("NIHR") publishes supportive health technology assessment into Company's technology

12 February 2009 - Deltex Medical Group plc ("Deltex Medical" or the "Company"), the global leader in oesophageal Doppler monitoring ("ODM"), today announces the publication of an important new report on the clinical and economic benefits of ODM.

The National Institute for Health Research (NIHR) report is a high-quality systematic review of the randomised controlled trials published to date using ODM (mostly the CardioQ-ODM™). With respect to major surgery, the Company's key target market, the report concludes that:

"The available evidence…suggests that the addition of ODM-guided fluid administration to CVP monitoring plus conventional assessment during surgery results in fewer major and total complications and a shorter length of hospital stay, and possibly fewer deaths, with pooled estimates for all outcomes showing a statistically significant difference in favour of the ODM group. Given these data it is quite plausible that the use of ODM in this situation would be less costly and more effective."

The report concludes that the available evidence to date about the use of ODM in the smaller intensive care market is less complete and recommends further research in this area. It also recommends a series of trials to fill perceived gaps in the surgical evidence base with the key recommendation that future ODM trials are specifically designed to address economic as well as clinical endpoints.

The report is available to download at www.ncchta.org/project/1633.asp.

Andy Hill, Deltex Medical's Chief Executive, commented:

"The NIHR report will be a very powerful tool in the hands of the many UK doctors already wanting to incorporate use of the CardioQ-ODM into their practice. Combined with new consensus guidelines on fluid management for surgical patients, the Centre for Evidence-based Purchasing report published last year and the recommendations of the NHS National Technology Adoption Centre's work with CardioQ-ODM due later this year, we are building a substantial body of independent NHS recommendations for the wide-scale adoption of the CardioQ-ODM.

"Much of the further research recommended by NIHR is already in hand. We expect that such additional research will make it increasingly difficult for any hospital to not implement ODM as a standard of care for major surgery."

For further information, please contact:-

Deltex Medical Group plc 01243 774 837

Nigel Keen, Chairman  njk@deltexmedical.com

Andy Hill, Chief Executive ahill@deltexmedical.com

Ewan Phillips, Finance Director eap@deltexmedical.com 

Gavin Anderson & Company 0207 554 1400

Deborah Walter dwalter@gavinanderson.co.uk

Robert Speed rspeed@gavinanderson.co.uk

Nominated Adviser & Broker

Arden Partners 020 7398 1600

Chris Hardie chris.hardie@arden-partners.com

  Notes for Editors

Deltex Medical manufactures and markets the CardioQ-ODM™ monitor, which uses disposable ultra-sound probes inserted into the oesophagus to determine the amount of blood being pumped around the body - 'circulating blood volume'. Reduced circulating blood volume is known as hypovolaemia, which leads to insufficient oxygen being delivered to the organs. This causes medical complications including peripheral and major organ failure which can lead to death. Hypovolaemia, which is akin to severe dehydration, affects virtually every patient having surgery because of the combined effects of pre-operative starvation, the impact of the anaesthetic agents and trauma from the surgery itself. Using fluids and drugs, guided by the CardioQ-ODM, to optimise the amount of circulating blood significantly reduces post-operative complications allowing patients to make a faster, more complete recovery and return home earlier.

The CardioQ-ODM incorporates the Company's proprietary software and a small diameter, easy-to-use, minimally invasive, disposable oesophageal probe that is used for transmitting and receiving an ultra-sound signal. By using this technology, the CardioQ-ODM provides clinicians with the ability to haemodynamically optimise critically ill patients and those undergoing routine moderate to major surgery through the controlled administration of fluid and drugs. Haemodynamic optimisation has been scientifically proven to improve the speed and quality of patient recovery and reduce hospital stay.

There are already over 1,600 CardioQ-ODMs currently in use in hospitals worldwide and distribution arrangements are in place in over 30 countries. Over 1,000 patients a week are treated using the CardioQ-ODM. In addition, there are currently approximately 200 clinical publications on the use of the CardioQ-ODM which have repeatedly:-

Validated the results of the Monitor against known standards for measuring cardiac output, demonstrating that the technology works

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

Demonstrated that the Company's technology provides significant health and economic benefits by helping to reduce post-operative complications and length of hospital stays by an average of 30 to 40 per cent for a wide range of patients.

The SupraQ™ is 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.