Deltex Medical Regulatory News (DEMG)

The information contained within this announcement was deemed by the Group to constitute inside information as stipulated under the UK Market Abuse Regulation

10 July 2023

Deltex Medical Group plc

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

Release of new next generation TrueVue System in the UK and the EU

Deltex Medical Group plc (AIM: DEMG), the global leader in oesophageal Doppler monitoring, is pleased to announce the UK and EU launch of its new next generation TrueVue System.

The launch follows the successful independent review of the electromagnetic compatibility (EMC) report on the new TrueVue monitor as well as the subsequent finalisation of the technical file, as referred to in the Group's announcement on 6 July 2023. With the new next generation TrueVue System now CE marked and released in the UK and EU, the Group is now able to deploy the device for in-hospital evaluations, to ensure that there are no teething issues with the launch, and will not fulfil any orders until this is completed. It is anticipated that this will take approximately 3 months and therefore the Group is forecasting revenue from new monitor sales to commence in November 2023. This is normal practice for any medical device, as it is not permitted to use a device in a hospital unless it has been CE marked.

The new TrueVue System combines independent measurements of blood flow and blood pressure in a patient across each and every heartbeat in real time, providing the clinician with a range of clinically validated haemodynamic parameters. These haemodynamic parameters are used by clinicians to assess the patient's cardiac function to guide fluid and drug therapy to optimise cardiovascular performance (heart contractility) or normalise circulating blood volume (normovolaemia).

The new next generation TrueVue System is a major advance over Deltex Medical's existing system. The light-weight portable multi-technology device is battery powered and has a significantly easier user interface. The technology is expected to be used in adult and paediatric patients undergoing surgery (including in Accident and Emergency (A&E)) or during treatment in critical care departments such as Intensive Care Units (ICU) or High Dependency Units (HDU).

The new next generation TrueVue System will also be the platform for the Group's new non-invasive Suprasternal device, which is currently under development. This device is aimed at the awake patient market and therefore has significantly broader applications than the current invasive device, such as in A&E, general wards and by paramedics. The new next generation TrueVue System and the new non-invasive Suprasternal device are a key part of the Group's future growth and long-term strategy.

Commenting on the launch, Andy Mears, CEO of Deltex Medical, said:

"We are delighted that we have launched the new next generation TrueVue System. This is against the challenging backdrop of having to conduct work on this project through Covid-19 and dealing with the associated supply chain issues.

I want to thank all of our employees for their hard work and resilience to get this completed.

Initial interest in the new monitor has been positive and we expect the launch to help increase activity levels in all territories ahead of other international regulatory approvals being obtained. We have been manufacturing new monitors in anticipation of starting to fulfil orders in November."

For further information, please contact:

Notes for Editors

Deltex Medical's technology

Deltex Medical's TrueVue System uses proprietary haemodynamic monitoring technology to assist clinicians to improve outcomes for patients as well as increase throughput and capacity for hospitals.

Deltex Medical has invested over the long term to build a unique body of peer-reviewed, published evidence from a substantial number of trials carried out around the world. These studies demonstrate statistically significant improvements in clinical outcomes providing benefits both to patients and to the hospital systems by increasing patient throughput and expanding hospital capacity.

The Group's flagship, world-leading, ultrasound-based oesophageal Doppler monitoring ("ODM") is supported by 24 randomised control trials conducted on anaesthetised patients. As a result, the primary application for ODM is focussed on guiding therapy for patients undergoing elective surgery. The Group's new, next generation monitor makes the use of the ODM technology more intuitive and provides augmented data on the status of each patient.

Deltex Medical's engineers and scientists carried out successful research in conjunction with the UK's National Physical Laboratory ("NPL"), which has enabled the Group's 'gold standard' ODM technology to be extended and developed so that it can be used completely non-invasively. This will significantly expand the application of Deltex Medical's technology to non-sedated patients. This new technological enhancement, which will be released on the new next generation monitor, will substantially increase the addressable market for the Group's haemodynamic monitoring technologies and is complementary to the long-established ODM evidence base.

Deltex Medical's new non-invasive technology has potential applications for use in a number of healthcare settings, including:

§ Accident & Emergency for the rapid triage of patients, including the detection and diagnosis of sepsis;

§ in general wards to help facilitate a real-time, data-driven treatment regime for patients whose condition might deteriorate rapidly; and

§ in critical care units to allow regular monitoring of patients post-surgery who are no longer sedated or intubated.

One of the key opportunities for the Group is positioning this new, non-invasive technology for use throughout the hospital. Deltex Medical's haemodynamic monitoring technologies provide clinicians with beat-to-beat real-time information on a patient's circulating blood volume and heart function. This information is critical to enable clinicians to optimise both fluid and drug delivery to patients.

Deltex Medical's business model is to drive the recurring revenues associated with the sale of single-use disposable ODM probes which are used in the TrueVue System and to complement these revenues with a new incremental revenue stream to be derived from the Group's new non-invasive technology.

Both the existing single-use ODM probe and the new, non-invasive device will connect to the same, next generation monitor launched in July 2023. Monitors are sold or, due to hospitals' often protracted procurement times for capital items, loaned in order to encourage faster adoption of the Group's technology.

Deltex Medical's customers

The principal users of Deltex Medical's products are currently anaesthetists working in a hospital's operating theatre and intensivists working in ICUs. This customer profile will change as the Group's new non-invasive technology is adopted by the market. In the UK the Group sells directly to the NHS. In the USA the Group sells directly to a range of hospital systems. The Group also sells through distributors in more than 40 countries in the European Union, Asia and the Americas.

Deltex Medical's objective

To see the adoption of Deltex Medical's next generation TrueVue System, comprising both minimally invasive and non-invasive technologies, as the standard of care in haemodynamic monitoring for all patients from new-born to adult, awake or anaesthetised, across all hospital settings globally.

For further information please go to www.deltexmedical.com