LiDCO Group Plc US FDA clearance for LiDCOunity v2 (3395H)

TIDMLID

RNS Number : 3395H

LiDCO Group Plc

07 June 2017

LiDCO Group Plc

("LiDCO" or the "Company")

US FDA clearance for LiDCOunity v2

LiDCO's latest Hemodynamic Monitoring Platform Receives US FDA 510k clearance

LiDCO (AIM: LID), the hemodynamic monitoring company, announces that it has been granted clearance from the US Food and Drug Administration (FDA) under Section 510(k) of the Food, Drug and Cosmetic Act to market its new advanced hemodynamic monitoring platform LiDCOunity v2.

The US dynamic hemodynamic monitoring market is experiencing significant growth and is estimated to be currently worth in excess of $100 million per annum. LiDCO's US expansion plans are progressing in line with expectations, with phase one now complete. This clearance by the FDA now means that the Company can accelerate its commercial launch activities.

Importantly the new LiDCOunity v2 monitor incorporates LiDCO's high usage programme software. This is a differentiated offering aimed at gaining market share in the world's largest hemodynamic market.

The striking new slim widescreen monitor platform, LiDCOunity v2, incorporates the core value proposition of combining the full suite of LiDCO technology into one offering. The new monitor brings together LiDCO's non-invasive, minimally invasive and calibrated technologies. Enabling continuous hemodynamic monitoring, including monitoring of level of consciousness across the entire clinical pathway in one monitor. In addition, it has a number of new additional features, such as an updated graphical user interface with a more intuitive menu system, internal battery for transportation and new clinical guidance protocols to aid users.

More information about LiDCOunity v2 can be found on our new website www.lidco.com

Commenting on the FDA clearance, Matt Sassone, Chief Executive Officer of LiDCO, said: "The clearance by the FDA means that medical institutions within the United States now have the opportunity to benefit from the next generation of hemodynamic technologies, as well as having access to LiDCO's high usage pricing programme. This is key to establishing LiDCO technology as a standard of care and gaining market share in the world's largest hemodynamic monitoring market. This announcement coincides with the conclusion of the first wave of our investment in additional US commercial resources, more than doubling our presence in this market. We look forward to what will no doubt be an exciting period ahead for LiDCO in the United States."

For further information, please contact:

 
 LiDCO Group Plc                          www.lidco.com 
 Matt Sassone (CEO)            Tel: [phone] 
 
 finnCap                       Tel: [phone] 
 Geoff Nash / Emily Watts 
  (Corporate Finance) 
 Stephen Norcross (Corporate 
  Broking) 
 
 Walbrook PR Ltd                  Tel: [phone] or 
                                   [e-mail] 
 Paul McManus                        Mob: [phone] 
 Lianne Cawthorne                    Mob: [phone] 
 

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, 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. Version 2 of this software is only available on a new slim widescreen monitor and includes the optional high usage program software in selected markets.

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.

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 ('BIS(TM') )* 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.

*BIS(TM) and Bispectral Index are trademarks of Medtronic registered in the US and foreign countries.

**CNAP(TM) 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 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

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June 07, 2017 02:00 ET (06:00 GMT)