Deltex Medical Regulatory News (DEMG)

4 May 2017

Deltex Medical Group plc

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

Deltex releases non-invasive High Definition Impedance Cardiography module on its CardioQ-ODM+ monitor platform

Deltex Medical Group plc (AIM: DEMG), the global leader in Oesophageal Doppler Monitoring ("ODM"), announces the launch of non-invasive High Definition Impedance Cardiography (HD-ICG) in the UK, as an additional module on its CardioQ-ODM+ monitoring platform.

HD-ICG provides a continuous indirect measurement of central blood flow. An electrical field is set up across the patient's chest following placement of a single patient disposable set of sensors on the abdomen. The disruption to this field caused by the heart pumping blood is measured and used to calculate cardiac output variables using an established nomogram. The sensors are connected to the Deltex monitor via a small console which also powers the sensors and values are displayed on specially designed screens on the CardioQ-ODM+.

The HD-ICG system is non-invasive making it ideal for monitoring patients in both critical care and surgery who are awake and do not tolerate ODM probes. Adding it to the CardioQ-ODM+ increases the numbers of patients the Company can treat.

The Company is launching the new product, which is CE marked, immediately in the UK and plans to introduce it into select overseas markets as the relevant foreign language versions are completed over the course of the year. The software upgrade necessary to add the new product to the US version of the CardioQ-ODM+ requires separate regulatory clearance which the Company is pursuing with the manufacturer's support.

Heads of agreement

Deltex has signed heads of agreement with the manufacturer giving it exclusive rights to sell HD-ICG into critical care and surgical settings initially in a number of key Deltex markets including the UK, France, Scandinavia, Spain and Peru with mechanisms in place for additional territories in due course. Release in the USA is also intended to be on an exclusive basis subsequent to gaining regulatory approval.

The agreement is for an initial three years with roll-over provisions and secures Deltex's ability to support the modules for ten years after any termination.

Investor open day demonstration

HD-ICG will be demonstrated at the investor open day at Deltex's Chichester facility on Friday 5 May. Investors or potential investors wishing to attend this meeting who have not already registered should email investorinfo@deltexmedical.com.

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

"The addition of High Definition Impedance Cardiography to our monitoring platform is an exciting development. It gives us an easy to use non-invasive cardiac output monitoring technology which is broadly complementary to our exisiting ODM technology.

"Following the 2012 addition of Pulse Pressure Waveform Analysis to CardioQ-ODM+, we are now able to offer our customers all three of the leading advanced haemodynamic monitoring technologies on a single platform. This means clinicians can choose the most appropriate technology for their monitoring requirements across the whole hospital."

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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.

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 3,400 monitors installed in hospitals around the world and around 700,000 patients have been treated to date using Deltex Medical's single patient disposable probes.