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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
1st May 20147:00 amRNSPositive haemodynamic monitoring study
29th Apr 20147:00 amRNSFinal Results
7th Apr 20147:00 amRNSNotice of Results and Investor briefing
17th Mar 20147:00 amRNSLaunch of New Version of LiDCOrapid software
12th Mar 20147:00 amRNSResults of cost effectiveness trial
28th Feb 201411:34 amRNSTotal Voting Rights
12th Feb 20147:00 amRNSTrading update and notice of results
7th Feb 20149:21 amRNSHolding(s) in Company
28th Jan 20143:01 pmRNSHolding(s) in Company
27th Jan 20144:10 pmRNSBlocklisting Application
20th Jan 20149:54 amRNSReplacement:Anaesthetists guidelines supports LID
20th Jan 20147:00 amRNSAnaesthetists guidelines supports LiDCO
18th Oct 20134:04 pmRNSExercise of Share Options
1st Oct 20137:00 amRNSHalf Yearly Report
26th Sep 20137:00 amRNSNotice of Patent Acceptance
20th Sep 20137:00 amRNSInvestor Results Briefing
6th Sep 20134:33 pmRNSHolding(s) in Company
4th Sep 20137:00 amRNSFDA clearance
20th Aug 20137:00 amRNSTrading update
13th Aug 201312:11 pmRNSNotification of major interest in shares
12th Jun 201311:43 amRNSResults of Annual General Meeting
12th Jun 20137:00 amRNSAGM Statement
10th Jun 201310:08 amRNSNotification of major interest in shares
5th Jun 20137:00 amRNSLiDCOrapid in successful recovery programme
31st May 20139:50 amRNSGrant of Share Options
17th May 20133:30 pmRNSNotice of AGM and posting of Annual Report
9th May 20137:00 amRNSLiDCOrapidv2 incorporated in NHS Foundation Trust
8th May 20133:51 pmRNSExercise of Share Options
23rd Apr 20137:00 amRNSPreliminary Results
26th Mar 20137:00 amRNSUS FDA clears for sale LiDCOrapidv2
15th Mar 20137:00 amRNSGrant of LiDCOrapid user interface patent in Japan
22nd Feb 20133:25 pmRNSDirector/PDMR Shareholding
21st Feb 201312:45 pmRNSExercise of Share Options
7th Feb 20137:03 amRNSLaunch and first sales of the LiDCOrapid v2
5th Feb 20137:00 amRNSTrading Update and Notice of Preliminary Results
17th Dec 20127:00 amRNSTrading Statement
29th Nov 20122:00 pmRNSTR-1 Notification of Major Interest in Shares
27th Nov 20127:00 amRNSExercise of Share Options
27th Nov 20127:00 amRNSProtocol using LiDCOrapid improves outcomes
23rd Nov 20127:00 amRNSLiDCOrapid v2 satisfies NICE recommendation
13th Nov 20127:00 amRNSFundraising to raise £2.35 million
23rd Oct 20127:00 amRNSInterim Results
15th Oct 20123:00 pmRNSExercise of Share Options
15th Oct 20127:00 amRNSPremier of LiDCOrapid v2 with Unity Software
14th Sep 20123:20 pmRNSNotice of Interim Results
3rd Sep 201212:00 pmRNSExercise of Share Options
23rd Aug 20127:00 amRNSTrading update and resignation of Director
3rd Aug 20127:00 amRNSNihon Kohden appointed as distributor in Japan
11th Jul 20127:00 amRNSReimbursement approval received in Japan
4th Jul 20123:05 pmRNSGrant of Share Option

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