Deltex Medical Regulatory News (DEMG)

2 July 2019

Deltex Medical Group plc 

("Deltex Medical" or the "Group")

Deltex Medical Receives Innovative Technology Contract From Vizient For CardioQ-EDM+ Esophageal Doppler Monitor (EDM+)

Deltex Medical Group plc (AIM: DEMG), the global leader in oesophageal Doppler monitoring, today announces that it has received an Innovative Technology contract from Vizient, Inc., the largest member-driven health care performance improvement company in the United States. The contract was based on the recommendation of hospital experts in haemodynamics who serve on one of Vizient's member-led councils. Innovative Technology contracts are reserved for technologies that demonstrate an ability to significantly enhance clinical care and patient safety, whilst improving an organisation's care delivery and business model.

In the USA, the CardioQ-EDM+, the US version of the CardioQ-ODM+, has regulatory approval for use on both adult and paediatric patients down to 3kg. The CardioQ-EDM+ measures blood flow velocity 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 blood flow and measures such changes in real-time. Deltex Medical is the only company in the enhanced haemodynamic space to have built a robust evidence base demonstrating both the clinical and economic benefits of its core technology. This technology has been proven in a wide range of clinical trials to significantly reduce complications suffered by patients after surgery and consequently save hospitals the costs of treating those complications. For that reason, the EDM+ has a specific physician reimbursement code (G9157) in the USA that covers operative patients with a need for intra-operative fluid optimisation along with the monitoring of cardiac output for ventilated patients in the Intensive Care Unit.

Since 2003, nearly 2,200 new and innovative products and technologies have been submitted through the Vizient Innovative Technology Program. Vizient works with member-led councils and task forces to identify and review potentially innovative products. If it is determined, as with the EDM+, that a product is innovative, a contract may be awarded outside Vizient's competitive bid cycle.

Andy Mears, CEO of Deltex Medical commented:

"The Board is appreciative of the award of this prestigious Vizient Innovative Technology contract, which recognises the important role the CardioQ-EDM+ plays in improving patient safety during and after surgery. Vizient is the largest member-driven healthcare improvement company in the United States, and its diverse membership and customer base includes academic medical centres, paediatric facilities, community hospitals, integrated health delivery networks and non-acute health care providers with combined purchasing volume of approximately $100 billion annually. Whilst there is no guarantee of sales, this new contract will provide Deltex Medical with increased visibility and easier access to technology for Vizient hospital members, which will help us expand our pipeline and US customer base."

For further information, please contact:

Notes for Editors

Deltex Medical manufactures and markets haemodynamic monitoring technologies. Deltex Medical's proprietary oesophageal doppler monitoring ("ODM") (TrueVue Doppler) measures blood flow velocity 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 blood flow and measures such changes in 'real time'. Deltex Medical is the only company in the enhanced haemodynamic space to have built a robust and credible evidence base demonstrating both the clinical and economic benefits of its core technology, TrueVue Doppler. This technology has been proven in a wide range of clinical trials to reduce complications suffered by patients after surgery and consequently save hospitals the costs of treating those complications.

Deltex Medical's TrueVue System on the CardioQ-ODM+ monitor platform now provides clinicians with two further advanced haemodynamic monitoring technologies. TrueVue Impedance is an entirely non-invasive monitoring technology which transmits low magnitude, high frequency electrical signals through the thorax and measures the changes to this signal when the heart pumps blood. TrueVue PressureWave uses the peripheral blood pressure signal analysis to give doctors information on changes in the circulation and is particularly suited to monitoring lower risk or haemodynamically stable patients.

Group goal

Haemodynamic management is now becoming widely accepted as an important part of the anaesthesia protocol for surgical patients. Consequently, the Group's focus is on maximising value from the opportunities presented, as enhanced haemodynamic management is adopted into routine clinical practice around the world. The Group aims to provide clinicians with a single platform - a 'haemodynamic workstation' - which offers them a range of technologies from simple to sophisticated to be deployed according to the patient's condition as well as the skill and expertise of the user. Doing this will enable the Group to partner healthcare providers to support modern haemodynamic management across the whole hospital.

The Group is currently in the implementation phase of achieving this goal in a number of territories worldwide, operating directly in the UK and the USA, and through distribution arrangements in approximately 40 other countries.