TIDMDEMG
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 p ortable
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
& Broker 020 3328 5656
Jeremy Porter / Vivek Bhardwaj (Corporate info@allenbycapital.com
Finance)
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
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