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Regulatory approval in China

29 Mar 2016 07:00

RNS Number : 2755T
LiDCO Group Plc
29 March 2016
 

 

 

LIDCO GROUP PLC

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

 

Regulatory approval in China

 

LiDCO (AIM: LID), the hemodynamic monitoring company, announces that it has received regulatory approval for LiDCOrapid v2, the Company's cardiac output monitor used in hospitals for fluid and drug management, for commercial sale in China.

 

The Chinese Food and Drug Administration (CFDA) has formally approved the Company's hemodynamic monitoring product for commercial sale in China and it will be sold via LiDCO's distributor partner Beijing Gloryway Medical Co., Ltd, a medical device sales group specialising in anesthesia and patient monitoring.

China has over 25,000 hospitals and represents approximately 5% of the global medical device market. Over the last few years an increasing number of clinical studies originating from China have been published reinforcing the positive impacts of hemodynamic monitoring. LiDCO, with its distribution partner, is working with a number of Key Opinion Leaders in China to develop the market.

Commenting Matt Sassone, Chief Executive Officer, said:

"Geographical expansion remains the biggest potential driver of future growth for LiDCO and we are delighted to receive approval to sell our LiDCOrapid v2 in a growing market that presents significant opportunities for LiDCO. Increasingly the benefits of hemodynamic monitoring are being recognised by doctors and care-providers around the world. Opening up the Chinese market, as well as our continued development of our international distribution network elsewhere, will help to ensure that LiDCO delivers growing value for shareholders."

 

 

 

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
 
END
 
 
REASELFWLFMSESD
Date   Source Headline
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19th Aug 20097:00 amRNSTrading Statement
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7th Jul 20091:48 pmRNSIssue of Equity
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28th May 20094:15 pmRNSGrant of Share Options
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28th Feb 20087:00 amPRNTrading Update
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25th Feb 20087:00 amPRNNotice of Results
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31st Dec 20079:19 amRNSChange of Adviser
13th Dec 200711:44 amPRNGrant of Options
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