Deltex Medical Regulatory News (DEMG)

Deltex Medical Group plc

("Deltex Medical", "the Company" or "the Group")

Clinical study validates PPWA element of CardioQ-ODM+

17 March 2015 - Deltex Medical Group plc (LSE-AIM: DEMG), the global leader in oesophageal Doppler monitoring ("ODM"), announces a new study validating the Pulse Pressure Waveform Analysis ('PPWA') algorithm in its CardioQ-ODM+ monitoring system.

The study, published in a leading anaesthetic journal by doctors at one of France's most renowned teaching hospitals, found that the 1928 PPWA formula of Liljestrand-Zander ('LZ') was markedly superior to eight other published PPWA algorithms. The LZ algorithm is used in the Company's CardioQ-ODM+ monitors which combine ODM and PPWA.

Compared to the gold standard ODM signal during surgery LZ was found to have a clinically acceptable percentage error of 26% whereas the other approaches had clinically unacceptable percentage errors ranging between 35% and 43%. LZ had the highest percentage of concordance (with 10% exclusion zone) to track the effect of fluid administration at 86% whereas the others ranged between 42% and 79%. The equivalent measures when trying to identify the sudden changes in haemodynamics caused by vaso-pressor administration were even more dramatic with LZ concordance of 94% compared to the other PPWA approaches where concordance ranged from 19% to 47%.

The authors conclude:

"The Liljestrand-Zander model seems very effective in tracking cardiac output changes induced by vasopressors and could be useful for monitoring cardiac output during haemodynamic instability in the OR during procedures when the Doppler signal could be unusable because of interference from electric scalpels. Moreover, [PPWA] could be recalibrated anytime with [ODM] value, and the combination of these two devices could facilitate continuous cardiac output monitoring in the operating theatre and increase accuracy of cardiac output monitoring."

References:

1. Caillard et al: Comparison of cardiac output measured by oesophageal Doppler ultrasonography or pulse pressure contour wave analysis. British Journal of Anaesthesia: advanced access March 2015

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

"This is important high quality validation of our CardioQ-ODM+ that shows we are offering clinicians two best in class technologies in the same monitor. We expect shortly to announce progress with new parameters based around the unique combination of ODM an PPWA."

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Notes for Editors

Deltex Medical manufactures and markets haemodynamic monitoring technologies. Deltex Medical's ODM is the only technology 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. Deltex has been the only company in the enhanced haemodynamic space to build a robust and credible evidence base proving the clinical and economic benefits of its core technology, ODM. 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.

During 2013, the Company launched the CardioQ-ODM+ monitor that offers clinicians both of the two best-established technologies, Deltex Medical's ODM technology as well as Pulse Pressure Waveform Analysis ('PPWA') in one monitor. This allows clinicians to have unique real time insights into each of flow, pressure and resistance, the three pillars of haemodynamics.

Company goal

ODM is increasingly recognised as a standard of care for patients undergoing major surgery and in critical care. The broader clinical area of haemodynamic management of which ODM is a core constituent is also now becoming widely accepted as an important major new medical modality. Consequently, the Company's focus is on maximising value from the opportunities presented as enhanced haemodynamic management is adopted into routine clinical practice around the world.

The Company is currently in the implementation phase of achieving this goal in a number of territories worldwide, operating directly in the UK, USA, Spain and Canada and through distribution arrangements in a further 30 countries.

There are over 3,200 monitors installed in hospitals around the world and over 600,000 patients have been treated to date using Deltex Medical's single patient disposable probes.