RNS Number : 8413A
LiDCO Group Plc
26 March 2013
 



 

Press Release

26 March 2013

 

LiDCO Group Plc

 

("LiDCO" or the "Company")

 

 

US FDA clears for sale LiDCOrapidv2 with Depth of Anesthesia display

 

LiDCO Group Plc (AIM:LID), the cardiovascular monitoring company, is pleased to announce that the US Food and Drug Administration (FDA) has cleared its new LiDCOrapidv2 monitor with Unity software and depth of anesthesia display for sale in the US. The US is the world's largest single market for fluid management and disposables use during high risk surgery with a market potential of approximately $650 million per annum. This registration follows on from the registration and launch of the LiDCOrapidv2 in the EU in February of this year.  LiDCOrapidv2 sales have already been made in both the UK and the EU with a highly positive reaction from customers.

 

The LiDCOrapidv2 with Unity software is the first monitor in the world to be designed specifically for multi-parameter monitoring of both depth of anesthesia and fluids. The Unity software allows the connection of Covidien's BISTM LOC 2 channel module to the LiDCOrapidv2 to co-display Covidien's depth of anesthesia parameter (BIS) alongside fluid monitoring. LiDCO believes that there is a trend within hospitals to move towards single devices that perform multiple functions. Through parameter integration, LiDCO's new monitor addresses a growing requirement for a multi-parameter display that reduces the number of single parameter monitors needed by the bedside.

 

Additional parameters can easily be added to further increase the breadth of monitoring displayed on the LiDCOrapidv2. LiDCO expect its additional continuous non invasive blood pressure monitoring option to be registered for sale in the US later this year.

 

The LiDCOrapidv2 with Unity software satisfies UK NICE (National Institute for Health and Clinical Excellence) recommendations for both the monitoring of fluids and depth of anesthesia in high risk surgery patients. From April 2013 the NHS in England will be providing payment incentives aiming to significantly increase the numbers of surgery patients that are fluid monitored from approximately 40,000 to 80,000 patients per year. The Board estimates that this equates to an additional £2.8 million of possible revenues.

 

Terry O'Brien, Chief Executive Officer of LiDCO, commented: "LiDCO's PC based monitor LiDCOrapidv2 is a multi-parameter platform that can address the potential global high risk surgery disposable market of $2 billion per annum. The US clearance for sale of LiDCO's new monitor, which combines fluid monitoring and depth of anesthesia in a single display, allows the Company to commence sales in the world's largest fluid market for these parameters. The Board estimates that 3.4 million patients are suitable for monitoring in the US alone. The next near term milestone for LiDCO in the US will be the additional registration for the display of the non-invasive blood pressure module option that, when available, is expected to substantially further expand LiDCO's market opportunity."

 

Notes:

BIS and Bispectral Index are trademarks of Covidien LP registered in the U.S. and foreign countries, for more information on BIS products see: www.covidien.com.

 

 

- ENDS -

 

 

For further information, please contact:

LiDCO Group Plc


Theresa Wallis (Chairman)

Tel: +44 (0)20 7749 1500

Paul Clifford (Finance Director)


John Rowland (Company Secretary)

www.lidco.com

 

FinnCap


Geoff Nash / Henrik Persson 

Stephen Norcross (broking)

Tel: +44 (0)20 7600 1658

www.finncap.com

 

Media enquiries:

Abchurch


Adam Michael / Simone Elviss / Jamie Hooper

Tel: +44 (0) 20 7398 7719

Jamie.hooper@abchurch-group.com

www.abchurch-group.com

 

About LiDCO Group Plc

LiDCO is a supplier of 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 anesthetists 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 will allow 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.

 

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 through a network of specialty critical care and anesthesia distributors in the rest of the world.

 

LiDCO's sales office is in Cambridge, its manufacturing facility and headquarters are in London and its shares are traded on AIM. For more information please see www.lidco.com.

 

 


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