FDA approves paediatric probes for launch in USA

RNS Number : 3486U

Deltex Medical Group PLC

29 July 2015

 



29 July 2015

Deltex Medical Group plc

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

FDA approves paediatric probes for August launch in USA

Deltex Medical Group plc (LSE-AIM: DEMG), the global leader in oesophageal Doppler monitoring ("ODM"), today announces that the US Government's Food and Drug Administration ("FDA") has approved the release of the Company's paediatric probes in the USA for use with its CardioQ-ODM+ monitors.

This dedicated paediatric probe is for use on children who weigh three or more kilograms and are under the age of sixteen. It is designed to monitor drug and fluid therapies in an intensive care environment, specifically cardiac function, evaluation of the surgical patient, fluid analysis in high blood loss surgery and peri-operative fluid management.

The paediatric probe has been sold in Europe for the last ten years and has achieved traction in a number of leading children's hospitals. In the USA there are a higher proportion of specialist paediatric hospitals in comparison to Europe, with a dedicated hospital for children in most of the larger cities.

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

"FDA approval for our paediatric monitoring systems and single patient probes is excellent news for paediatricians in the USA who have, to date, had no safe or easy system in place to understand and monitor sick children's' haemodynamics in a surgical setting."

"There is a clear but unfulfilled clinical need for our products and we are already in discussion with a number of major children's' hospitals wanting to trial the CardioQ-ODM+. We expect to generate first revenues in the second half of the year."

For further information, please contact:-

Deltex Medical Group plc	01243 774 837 [e-mail]
Nigel Keen, Chairman
Ewan Phillips, Chief Executive
Barry Curtis, Company Secretary
Nominated Adviser & Broker
Arden Partners plc	020 7614 5900
Chris Hardie
Joint Broker Zeus Capital Limited Phil Walker Dominic Wilson	020 7533 7727
Financial Public Relations
Newgate	020 7653 9850
Tim Thompson
Robyn McConnachie Ed Treadwell

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.

 

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