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Regulatory approval in South Korea

17 Apr 2019 07:00

RNS Number : 4044W
LiDCO Group Plc
17 April 2019
 

LiDCO Group Plc

("LiDCO" or the "Company")

 

Regulatory approval in South Korea

 

LiDCO (AIM: LID), the hemodynamic monitoring company, announces that it has received regulatory approval for LiDCOrapid v3, the Company's latest cardiac output monitor with non-invasive technology, for commercial sale in South Korea.

 

The Korean Ministry of Food and Drug Safety has formally approved the Company's hemodynamic monitoring product for commercial sale in South Korea and it will be sold via LiDCO's distribution partner Globaluck Ltd, a medical device sales group specialising in anesthesia and patient monitoring.

South Korea's healthcare market is ranked fourth (by total medical device market size) among countries in the Asia-Pacific region. The country has an established hemodynamic monitoring market with local reimbursement already in place. LiDCO, via its distribution partner, will launch LiDCOrapidv3 at the 39th Annual Congress Korean Society of Critical Care Medicine which will be held in Seoul, South Korea on the 26 April 2019.

Commenting Matt Sassone, Chief Executive Officer, said:

"This is an exciting development for our business in South East Asia. Geographical expansion remains the biggest potential driver of future growth for LiDCO, South Korea is a new market for LiDCO, so we are delighted to receive approval to sell our LiDCOrapid v3 in a growing market that presents significant opportunities for LiDCO."

 

 

For further information, please contact:

 

LiDCO Group Plc

www.lidco.com

Matt Sassone (CEO)

Tim Hall (CFO)

Tel: +44 (0)20 7749 1500

finnCap

Tel: +44 (0)20 7600 1658

Geoff Nash / Hannah Boros (Corporate Finance)

Andrew Burdis (ECM)

Walbrook PR Ltd

Tel: 020 7933 8780 or lidco@walbrookpr.com

Paul McManus (Media Relations)

Mob: 07876 741 001

Lianne Cawthorne (Media Relations)

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. 

 

A number of clinical studies have shown 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.

 

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 Medtronic'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 Medtronic registered in the US and foreign countries.

**CNAPTM is a trademark of CNSystems Medizintechnik AG.

 

LiDCO monitors use single-patient disposables (sensors or smartcards) and are also available in many markets as a software for service model all of which provide a recurring 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 news service of the London Stock Exchange. RNS is approved by the Financial Conduct Authority to act as a Primary Information Provider in the United Kingdom. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact rns@lseg.com or visit www.rns.com.
 
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REAEAKLKFFSNEFF
Date   Source Headline
5th Dec 20077:00 amPRNClinical Study Results
16th Nov 20077:00 amPRNPlacing of Shares
30th Oct 20077:00 amPRNInterim Results
29th Aug 20077:00 amPRNTrading Statement
15th Aug 20073:11 pmPRNAIM Rule 26
31st Jul 200712:45 pmPRNDirector/PDMR Shareholding
17th Jul 20077:00 amPRNAnnual Report and Accounts
28th Jun 20079:35 amPRNDirector/PDMR Shareholding
25th Jun 20075:14 pmPRNGrant of Options
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20th Jun 20077:00 amPRNUS Patent Grant
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9th May 20077:00 amPRNApproval of Products in South Korea
24th Apr 20073:10 pmPRNNotice of AGM
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22nd Jan 20075:48 pmPRNDirectorate Change
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28th Apr 200612:57 pmPRNFinal Results
25th Apr 20066:20 pmPRNChange of results day
25th Apr 20067:00 amPRNSoftware Link with Picis
28th Mar 20067:00 amPRNAward Win
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