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Regulatory Filings • Apr 4, 2016

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RNS Number : 9763T

LiDCO Group Plc

04 April 2016

LIDCO GROUP PLC

("LiDCO" or the "Company" or "the Group")

US FDA 510k clearance for LiDCOunity

LiDCO (AIM: LID), the hemodynamic monitoring company, announces that it has been granted 510k market clearance from the US Food and Drug Administration (FDA) for its latest product, the LiDCOunity, a patient monitoring system that combines the full suite of LiDCO technology in one monitor.

LiDCOunity brings together LiDCO's non-invasive, minimally invasive and calibrated technologies to allow seamless, continuous monitoring from pre-induction through surgery and onto recovery in the Intensive Care Unit or other High Dependency Units. This beneficial combination allows for the first time both continuous hemodynamic monitoring, as well as monitoring of level of consciousness, across the entire clinical pathway on a single monitor. LiDCOunity has the flexibility to meet our customers' needs, enabling patients to benefit from hemodynamic monitoring and continuous non-invasive blood pressure monitoring at any stage of their treatment and in all of the hospital locations where such care is required.

Commenting Matt Sassone, Chief Executive Officer, said: 

"LiDCOunity combines the full suite of LiDCO technology into one product, offering our customers the ability to use one monitor and one disposable for the whole acute care patient pathway. This is a unique differentiator and maintains our technology leadership position. The US is the world's single largest market for hemodynamic monitoring in high risk surgery and is expanding as hospitals implement Enhanced Recovery after Surgery (ERAS) and Perioperative Surgical Home (PSH) programmes. This FDA approval is key to ensure that we are able to offer surgeons and anaesthetists our latest suite of technology."

LiDCO Group Plc	www.lidco.com
Matt Sassone (CEO)	Tel: +44 (0)20 7749 1500
Paul Clifford (Finance Director)
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, 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 (LiDCOplus, LiDCOrapid and LiDCOview) 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.

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 (PPV% and SVV%).

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 Covidien's level of consciousness parameter ('BISTM')* 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.

*BISTM and Bispectral Index are trademarks of Covidien LP registered in the US and foreign countries.

**CNAPTM 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 marketing office is in Cambridge, its manufacturing facility and 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

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