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

25 April 2023

Deltex Medical Group plc

("Deltex Medical" or the "Group")

New monitor expected to launch in June 2023

£0.25 million bridging loan to help fund working capitalassociated with accelerated production of the new monitor

Deltex Medical Group plc (AIM: DEMG), the global leader in oesophageal Doppler monitoring, today provides an update on its new monitor and announces that it intends to launch the product in June 2023.

The Group's technical department has conducted a detailed review of the small number of outstanding items that need to be addressed in order to complete the new monitor's regulatory technical file. Based on this review, the technical file, as well as other related regulatory submissions, are expected to be finalised by the end of May 2023. This will enable the Group to start the first production run of the new monitor in June, with shipments anticipated at the end of that month.

In order to capitalise on market interest in, and anticipated demand for, the new monitor, Deltex Medical wishes to accelerate the placement of orders for components required for the initial, and subsequent, production runs for the new monitor. Accordingly, the Board has entered into an agreement with Imperialise Limited, a company controlled by Mr. Nigel Keen, Chairman of Deltex Medical and the Group's largest shareholder, for a bridging loan of £0.25 million to fund the additional working capital. The Board is satisfied that the Group has sufficient working capital for the foreseeable future based on its budget for the year, but this new bridging loan will allow the Group to enter into additional commitments with its supply chain to accelerate the build of new monitors in anticipation of demand, as well as investing in marketing programmes around the launch of the new product.

The loan is unsecured, carries an interest rate of 12% per annum and has a minimum term of three months, after which time Imperialise Limited can demand its repayment at any time. 

Commenting on the new monitor, Andy Mears, Chief Executive of Deltex Medical, said:

"Now we have a launch date for the new monitor we need to make sure we have sufficient units being built to satisfy expected demand. Initial interest in the new monitor has been good and we look forward to following up this interest with a timely supply of the new product."

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 will shortly launch a new, next generation monitor which will make the use of the ODM technology more intuitive and provide 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 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 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