LiDCO Group Plc US FDA clearance for LiDCOunity v2 (3395H)
June 07 2017 - 1:00AM
UK Regulatory
TIDMLID
RNS Number : 3395H
LiDCO Group Plc
07 June 2017
LiDCO Group Plc
("LiDCO" or the "Company")
US FDA clearance for LiDCOunity v2
LiDCO's latest Hemodynamic Monitoring Platform Receives US FDA
510k clearance
LiDCO (AIM: LID), the hemodynamic monitoring company, announces
that it has been granted clearance from the US Food and Drug
Administration (FDA) under Section 510(k) of the Food, Drug and
Cosmetic Act to market its new advanced hemodynamic monitoring
platform LiDCOunity v2.
The US dynamic hemodynamic monitoring market is experiencing
significant growth and is estimated to be currently worth in excess
of $100 million per annum. LiDCO's US expansion plans are
progressing in line with expectations, with phase one now complete.
This clearance by the FDA now means that the Company can accelerate
its commercial launch activities.
Importantly the new LiDCOunity v2 monitor incorporates LiDCO's
high usage programme software. This is a differentiated offering
aimed at gaining market share in the world's largest hemodynamic
market.
The striking new slim widescreen monitor platform, LiDCOunity
v2, incorporates the core value proposition of combining the full
suite of LiDCO technology into one offering. The new monitor brings
together LiDCO's non-invasive, minimally invasive and calibrated
technologies. Enabling continuous hemodynamic monitoring, including
monitoring of level of consciousness across the entire clinical
pathway in one monitor. In addition, it has a number of new
additional features, such as an updated graphical user interface
with a more intuitive menu system, internal battery for
transportation and new clinical guidance protocols to aid
users.
More information about LiDCOunity v2 can be found on our new
website www.lidco.com
Commenting on the FDA clearance, Matt Sassone, Chief Executive
Officer of LiDCO, said: "The clearance by the FDA means that
medical institutions within the United States now have the
opportunity to benefit from the next generation of hemodynamic
technologies, as well as having access to LiDCO's high usage
pricing programme. This is key to establishing LiDCO technology as
a standard of care and gaining market share in the world's largest
hemodynamic monitoring market. This announcement coincides with the
conclusion of the first wave of our investment in additional US
commercial resources, more than doubling our presence in this
market. We look forward to what will no doubt be an exciting period
ahead for LiDCO in the United States."
For further information, please contact:
LiDCO Group Plc www.lidco.com
Matt Sassone (CEO) Tel: +44 (0)20 7749 1500
finnCap Tel: +44 (0)20 7600 1658
Geoff Nash / Emily Watts
(Corporate Finance)
Stephen Norcross (Corporate
Broking)
Walbrook PR Ltd Tel: 020 7933 8780 or
lidco@walbrookpr.com
Paul McManus Mob: 07980 541 893
Lianne Cawthorne Mob: 07584 391 303
About LiDCO Group Plc (www.lidco.com)
LiDCO is a supplier of non-invasive and minimally invasive
hemodynamic equipment to hospitals used to monitor the amount of
blood flowing around the body and ensure that vital organs are
adequately oxygenated. LiDCO's products facilitate the application
of hemodynamic optimisation protocols for high risk patients in
both critical care units and in the operating theatre.
Increasingly clinical studies are showing that the optimisation
of patients' hemodynamic status in high risk patients produces
better outcomes and reduced hospital stay. LiDCO's computer-based
technology, originally developed at St Thomas' Hospital in London,
has been shown to significantly reduce morbidity and complications,
length of stay and overall costs associated with major surgery.
Key Products:
LiDCOunity: a hemodynamic monitor that combines the full suite
of LiDCO technology (non-invasive, minimally invasive and
calibrated technologies) into one platform. Designed to have the
flexibility to adapt to a patient's changing acuity, the product
enables clinicians to seamlessly transition between non-invasive,
minimally invasive and calibrated hemodynamic monitoring. Version 2
of this software is only available on a new slim widescreen monitor
and includes the optional high usage program software in selected
markets.
LiDCOplus: a computer-based platform monitor used in the
Intensive Care Unit for real-time continuous display of hemodynamic
parameters including cardiac output, oxygen delivery and
fluid-volume responsiveness.
LiDCOrapid: a cardiac output monitor designed specifically for
use in the operating theatre for fluid and drug management. The
monitor enables anaesthetists to receive accurate and immediate
feedback on the patient's fluid and hemodynamic status - a key
measure of overall well-being before, during and after surgery. The
LiDCOrapid provides:
-- early and rapid warning of hemodynamic change to aid choice
of therapeutic route: fluid or drug
-- quantification of hemodynamic response guidance on effective
delivery of fluids to ensure the right amount at the right time
The software incorporated into LiDCOrapid allows the LiDCOrapid
monitor to co-display Medtronic's level of consciousness parameter
('BIS(TM') )* and add the convenience of CNSystem's continuous
non-invasive blood pressure monitoring ('CNAP')**. This addresses a
growing requirement for non-invasive monitoring solutions that are
more comprehensive and can effectively replace multiple single
parameter monitors.
LiDCOview: an easy-to-use graphical display of historical
LiDCOplus and LiDCOrapid hemodynamic data.
*BIS(TM) and Bispectral Index are trademarks of Medtronic
registered in the US and foreign countries.
**CNAP(TM) is a trademark of CNSystems Medizintechnik AG.
LiDCO monitors use single-patient disposables (sensors or
smartcards) which provide an ongoing revenue stream.
LiDCO Distribution Network:
LiDCO sells directly to hospitals in the UK and USA and through
a network of specialty critical care and anaesthesia distributors
in the rest of the world.
LiDCO's headquarters are in London and its shares are traded on
AIM.
This information is provided by RNS
The company news service from the London Stock Exchange
END
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