LID.L Regulatory News (LID)

LiDCO Group Plc

("LiDCO" or the "Company")

FDA clears for sale non-invasive blood pressure monitor

LiDCO Group Plc (AIM: LID), the cardiovascular monitoring company, announces that it has received clearance from the US Food and Drug Administration ('FDA') for sales of the CNSystems' continuous non-invasive blood pressure monitoring ('CNAPTM') module with the LiDCOrapidv2 monitor with Unity software.

LiDCO's Unity software allows the connection to the LiDCOrapidv2 of modules to co-display CNSystems' continuous non-invasive blood pressure monitoring with Covidien's depth of anaesthesia parameter ('BISTM'). LiDCO believes there is growing demand for a multi-parameter monitor display which can reduce the number of single parameter monitors by the patient bedside.

The Company estimates that 3.4 million patients are suitable for peri-operative hemodynamic monitoring in the US alone and with FDA clearance now received the commercial opportunity for LiDCO to gain presence in the non-invasive monitoring market in the US is substantial. LiDCO received CE marking for sales in Europe of the LiDCOrapid v2 with both modules in February 2013 and FDA clearance for the LiDCOrapid v2 with the BISTM parameter in March 2013.

Commenting, Terry O'Brien, Chief Executive Officer of LiDCO, said: "I am delighted we have met this key milestone in our strategy for expanding our presence in the US intraoperative fluid monitoring market. This approval has increased LiDCO's market opportunity considerably and we expect that by further increasing the breadth of monitoring displayed on the LiDCOrapid v2 we will make our products more attractive, particularly in response to an increasing requirement within hospitals to move towards multi parameter monitors."

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About LiDCO Group Plc (www.lidco.com)

LiDCO is a supplier of non-invasive and minimally invasive hemodynamic equipment to hospitals, 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:

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 get 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

LiDCOview: an easy-to-use graphical display of historical LiDCOplus and LiDCOrapid hemodynamic data.

LiDCO Unity Software: The software incorporated into LiDCOrapid v2 allows the LiDCOrapid monitor to co-display Covidien's level of consciousness parameter and add the convenience of CNSystem's* continuous non-invasive blood pressure monitoring. This will address a growing requirement for non-invasive monitoring solutions that are more comprehensive and can effectively replace multiple single parameter monitors. 

* CNAPTM is a trademark of CNSystems Medizintechnik AG.

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

All LiDCO monitors use single-patient disposables (sensors or smartcards) which provide an ongoing revenue stream.

LiDCO Distribution Network:

LiDCO's strategy is to sell 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.