LID.L Regulatory News (LID)

LiDCO Group Plc

("LiDCO" or the "Company")

Regulatory approval in China

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

The Chinese Food and Drug Administration (CFDA) has formally approved the Company's hemodynamic LiDCOrapidv3 monitor product for commercial sale in China and it will be sold via LiDCO's distribution partner, Beijing Gloryway Medical Co., Ltd ("Gloryway"), a medical device sales group specialising in anaesthesia and patient monitoring.

China is the second largest healthcare market in the world with a five-year compound annual growth rate by value of 17% compared with 4% in the United States1. Over the last few years an increasing number of clinical studies originating from China have been published reinforcing the positive impacts of hemodynamic monitoring and as a result this has led to increasing adoption of hemodynamic monitoring technologies. LiDCO, through its distribution partner, had built a significant business before regulatory restrictions to a key component in 2017 limited sales. With this approval, these restrictions no longer apply and the Board anticipates that Gloryway will re-launch the LiDCO offering with renewed vigour in the second half of 2019.

1 - Major healthcare markets defined as top five global markets by the World Health Organization. 6/30/2018

Commenting, Matt Sassone, Chief Executive Officer of LiDCO, said: "Since 2017, the Group has made limited sales to its Chinese distribution partner, and this approval enables us to re-launch with our latest monitor to a very important, rapidly growing market. Having continued to promote the LiDCO brand in the intervening period we believe that, in the next 2-3 years, we can significantly exceed historical levels of sales."

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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 (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) 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.