FDA approves CardioQ-ODM+

RNS Number : 1443R

Deltex Medical Group PLC

23 October 2013

 



Deltex Medical Group plc

("Deltex Medical" or "the Company")

FDA approves CardioQ-ODM+

23 October 2013 - Deltex Medical Group plc, the global leader in oesophageal Doppler monitoring ("ODM"), today announces that it has received approval from the US Food and Drug Administration ('FDA') to market the CardioQ-ODM+ monitor in the USA.

The CardioQ-ODM+ is the first haemodynamic monitoring system to combine cardiac output measurements derived from aortic flow (ODM) and arterial pressure (Pulse Pressure Waveform Analysis 'PPWA'). It was launched in Europe in 2012 where it has already become the Company's most popular monitoring solution. Pre-launch marketing at the recent annual congress of the American Society of Anesthesiologists has generated considerable interest and included the inaugural meeting of an expert group of clinicians combining leading academics and early implementers of ODM.

Deltex Medical is launching the CardioQ-ODM+ monitor in the USA with immediate effect. The Company built stock of these monitors in the first half of the year in anticipation of this FDA approval. It expects to have installed all or almost all of these within three months and is now building a second batch.

Initial installations will include monitors with a sales value in excess of £0.5m made available to clinicians for defined research purposes. Similar transactions have previously involved the hospitals taking title to the monitors in return for providing research services and have been accounted for as sales on a barter basis with the costs carried forward and written off as the research is completed. As indicated in the interim results statement, the Company's intention is now to maintain title to the monitors under the terms of the research agreements: therefore the Company does not intend to account for the installation of these monitors as sales and does not intend to carry forward or amortise the corresponding costs of research.

Ewan Phillips, Chief Executive of Deltex Medical, commented:

"We are delighted to have got FDA approval to launch the CardioQ-ODM+ in the USA. It has already generated considerable interest amongst leading US clinicians. By combining two previously competing technologies, it offers doctors the most complete picture available of patients' haemodynamic status and, therefore, the most sophisticated range of intervention options. With a strong foothold already in the US via our first generation of monitors, we are confident in our ability to continue to grow our US hospital base and recurring probe related revenue."

For further information, please contact:-

Deltex Medical Group plc	01243 774 837 [e-mail]
Nigel Keen, Chairman
Ewan Phillips, Chief Executive
Paul Mitchell, Finance Director
Nominated Adviser & Broker
Arden Partners plc	020 7614 5900
Chris Hardie
Financial Public Relations
Newgate Threadneedle	020 7653 9850
Graham Herring
Caroline Evans-Jones
Heather Armstrong

Notes for Editors

Deltex Medical manufactures and markets CardioQ-ODMÔ Oesophageal Doppler Monitoring ('ODM') systems. ODM is the only therapy to measure blood flow in the central circulation in real time. Minimally invasive, easy to set up and quick to focus, the technology generates a low-frequency ultrasound signal, which is highly sensitive to changes in flow and measures them immediately. Randomised, controlled trials using Doppler have demonstrated that early fluid management intervention will reduce post-operative complications, reduce intensive care admissions, and reduce the length of hospital stay.

The CardioQ-ODM has two distinct established clinical applications: firstly, to guide fluid management during surgery and secondly, to monitor cardiac output in critical care settings.

Surgical market

In March 2011 the National Institute for Health & Clinical Excellence ('NICE') recommended that CardioQ-ODM be considered for use in patients undergoing major and high risk surgery and in high risk patients undergoing intermediate risk surgery. NICE estimated the applicable number of such patients in the NHS in England alone to be over 800,000 each year. CardioQ-ODM has been shown to be effective in both elective and emergency surgery and with both general and regional anaesthetics. This recommendation was specific to CardioQ-ODM and was based on the robust evidence base that supports its use.

Subsequent to the NICE guidance, the NHS in England announced its selection of ODM as a high impact innovation to be rolled out across the system fully, at pace and scale with significant financial penalties starting in the NHS 2013/14 financial year ending 31 March 2014.

The NICE evaluation and recommendation confirms that the potential global market for CardioQ-ODM in surgery includes tens of millions of patients, even if confined to developed health economies: the most conservative estimate of the potential value of the market opportunity Deltex Medical has created is in excess of £1 billion per annum. The Company's core focus is on building market leading positions in this surgical market, both geographically and by type of surgery.

Critical care market

In critical care settings, well-equipped hospitals will often have more than one cardiac output monitoring technology available. In this environment, ODM's strengths are that it is quick to set up, easy to use, safe, low cost and the ideal technology for a patient in crisis requiring rapid or frequent intervention. The potential market for cardiac output monitoring in critical care is a fraction of the size of that for intra-operative fluid management.

Through the 2012 launch of the CardioQ-ODM+, Deltex Medical has added the Pulse Pressure Waveform Analysis ('PPWA') approach to monitoring cardiac output to ODM functionality. Doing this has improved Deltex Medical's offer for monitoring applications as well as providing doctors and nurses with a choice of clinical strategies appropriate to individual patients in different clinical settings.

Company goal

Our goal is to make oesophageal Doppler monitoring (ODM) a standard of care for patients in both these markets. We believe that, in most modern health systems, it is essential to have a robust evidence base of both clinical benefit and cost effectiveness in order to achieve system-wide adoption of a new medical technology. Deltex Medical is one of the very first medical technology companies to have completed the investment necessary to build such an evidence base: as a result, use of ODM during surgery has the proven potential to deliver both clinical and economic benefits that are material at each of patient, hospital and system level.

The Company is currently in the implementation phase of achieving this goal in a number of territories worldwide and there are already over 2,800 CardioQ-ODM systems in use in hospitals worldwide. Distribution arrangements are in place in over 30 countries.

 

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