Deltex Medical Regulatory News (DEMG)

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

22 December 2022

Deltex Medical Group plc

("Deltex Medical" or the "Group")

Year end update

New Monitor - update on regulatory approvals

Extension of standby loan facility by £0.25 million

Deltex Medical Group plc (AIM: DEMG), the global leader in oesophageal Doppler monitoring, is pleased to announce that its year-to-date revenues are ahead of the Group's full year 2021 revenue figures. In addition, the Group has a large advanced opportunity in the pipeline which if successful, could provide a further boost to revenue in the short term.

The Group has made good progress towards completing its innovative, next generation TrueVue monitor (the "New Monitor"). The Group's original intention had been to ship the New Monitor and subsequently invoice customers this year. However, regulatory approvals needed before the New Monitor can be launched onto the market will take several more weeks to be completed, including further testing. This delay has been caused by headwinds associated with strains in global supply chains that delayed the start of the approval process, including the completion of the testing for regulatory compliance.

During 2022 Deltex Medical has shown the New Monitor to a number of customers with a view to them purchasing the New Monitor. The Group is pleased to report that interest has been strong, and the Group has already won a tender in respect of the New Monitor at a price point significantly higher than price levels typically achieved for the current monitor. Deltex Medical expects strong demand from its distributors and end-users in relation to replacing legacy monitors, once the New Monitor has been released for sale.

The business has been tightly managed and therefore operating costs are lower than originally anticipated. However, in order to help fund the increased cash requirements associated with the unexpected delay in the launch of the New Monitor, Mr. Nigel Keen, the Company's largest shareholder and Chairman, has agreed to provide further cash support to Deltex Medical, on arm's length commercial terms.

Accordingly, the Board has entered into an agreement with Imperialise Limited, a company controlled by Mr. Nigel Keen, for a loan of £0.25 million by way of extension to the existing £0.5 million standby loan facility that was put in place and announced by the Company on 20 September 2021 and is now fully drawn down. The interest rate on the facility remains at 8% per annum, and it is unsecured. The £0.75 million standby loan facility is repayable in full on or before 31 December 2023.

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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.

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, an important capability for patients presenting with COVID-19 symptoms;

§ 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 which is due for launch in 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 more than 30 major hospitals that appreciate the value of Deltex Medical's evidence-based approach to haemodynamic management. 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