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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
29th Mar 20167:00 amRNSRegulatory approval in China
24th Mar 20167:00 amRNSMaster distribution agreement & other distributors
15th Mar 20167:00 amRNSLaunching the new LiDCOunity at ISICEM Brussels
4th Mar 20164:31 pmRNSHolding(s) in Company
2nd Mar 20165:06 pmRNSBlock Listing Review
8th Feb 20167:00 amRNSTrading update
2nd Feb 20163:52 pmRNSHolding(s) in Company
23rd Nov 20157:00 amRNSMaster distribution agreement
16th Nov 20154:35 pmRNSDirector's Dealing
13th Oct 20158:30 amRNSUS purchasing agreement with US hospitals group
13th Oct 20157:00 amRNSHalf Yearly Report
23rd Sep 201510:03 amRNSNotice of Results
2nd Sep 20157:00 amRNSTrading update and notice of results
17th Aug 20157:00 amRNSFormal appointment of Chief Executive Officer
31st Jul 20157:00 amRNSBlock Listing Review
15th Jun 20152:27 pmRNSBoard appointment and grant of share options
11th Jun 20157:00 amRNSJapan reimbursement for LiDCOrapidv2 disposables
13th May 201511:45 amRNSResult of AGM
6th May 20157:01 amRNSCEO and Board Appointment
5th May 20151:32 pmRNSPosting of Annual Report & Notice of AGM
23rd Apr 20157:00 amRNSLiDCO data presented at London Forum
14th Apr 20157:00 amRNSHolding in Company
1st Apr 201512:49 pmRNSDirector/PDMR Shareholding
31st Mar 20157:01 amRNSLIDCOrapid v2 cleared for sale in Japan
31st Mar 20157:00 amRNSFinal Results
17th Mar 20157:00 amRNSShowcasing Portable LiDCO Stand System at ISICEM
10th Mar 20157:03 amRNSNotice of Results
2nd Mar 20156:14 pmRNSHolding(s) in Company
17th Feb 20157:00 amRNSFurther clinical support for LiDCOrapid
12th Feb 20157:00 amRNSTrading update and notice of results
30th Jan 201512:20 pmRNSBlock listing review
17th Dec 20142:39 pmRNSHolding(s) in Company
1st Dec 20142:39 pmRNSHolding(s) in Company
17th Nov 20147:00 amRNSFurther clinical support for LiDCOrapid
12th Nov 20145:15 pmRNSHolding(s) in Company
7th Nov 201412:03 pmRNSHolding(s) in Company
3rd Nov 20145:49 pmRNSHolding(s) in Company
16th Sep 20147:01 amRNSBoard Announcement
16th Sep 20147:00 amRNSHalf Yearly Report
21st Aug 201411:39 amRNSNotice of Results
18th Aug 20147:00 amRNSTrading update
31st Jul 20141:46 pmRNSBlock Listing Review
30th Jul 20147:00 amRNSFurther clinical support for LiDCO products
11th Jun 201412:45 pmRNSResult of AGM
11th Jun 201411:49 amRNSResult of AGM
11th Jun 20147:00 amRNSAGM Statement
23rd May 20141:51 pmRNSPosting of Annual Report & Notice of AGM
22nd May 20144:01 pmRNSHolding(s) in Company
21st May 20147:00 amRNSMonitors Link with NantHealth's DeviceConX System
20th May 20147:00 amRNSResults of the OPTIMISE study

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