REG - Deltex Med Grp PLC - Release of new next generation TrueVue System

Deltex MedicalAnnouncement

10/07/2023 07:00

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RNS Number : 4764F  Deltex Medical Group PLC  10 July 2023

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:

 

 Deltex Medical Group plc                                        01243 774 837

 Nigel Keen, Chairman                                            investorinfo@Deltexmedical.com
 Andy Mears, Chief Executive
 Natalie Wettler, Group Finance Director

 Allenby Capital Limited - Nominated Adviser                     020 3328 5656

& Broker

 Jeremy Porter / Vivek Bhardwaj (Corporate Finance)              info@allenbycapital.com
 Tony Quirke / Stefano Aquilino (Sales & Corporate Broking)

 

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
(http://www.deltexmedical.com)

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