SENS.L Regulatory News (SENS)

Sensyne Health makes GDm-Health™ remote monitoring system for the management of diabetes in pregnancy available free-of-charge across NHS in response to COVID-19 pandemic

Highlights:

· GDm-Health enables remote monitoring of pregnant women in light of UK government guidelines to comply with social distancing and care away from hospitals & clinics

· Product is clinically proven to improve outcomes for pregnant women and reduce burden on NHS

· Product is approved and has been deployed across 16 NHS Trusts in the UK since its launch in Aug 2018

· Company will work collaboratively with the NHS to broaden the use of the product across the UK

Oxford, U.K. 27 March 2020: Sensyne Health plc (LSE: SENS) ("Sensyne" or the "Company" or the "Group"), the British Clinical AI technology company, today announces that in response to new UK government guidelines for all pregnant women to avoid face-to-face contact for three months, it will be providing its GDm-Health digital therapeutic product free to NHS Trusts for one year.

GDm-Health is a digital therapeutic for the remote management of women with diabetes during pregnancy by their clinical care team. Comprising a smartphone application connected to a wireless blood glucose monitor, the patient's near real-time data that has been prioritised by algorithms. This is communicated directly to the hospital team supervising care, enabling this high-risk group to monitor their condition safely at home.

GDm-Health is regulated, CE marked and clinically validated and can be rapidly deployed. Already commercially available and in-use at 16 NHS trusts, Sensyne Health will work collaboratively with the NHS to broaden the use of the product.

Lord (Paul) Drayson, CEO of Sensyne Health, said: "In light of the UK government's guidelines around 'social distancing' to combat the ongoing COVID-19 pandemic, there is now a greater focus than ever before on the use of remote patient monitoring to reduce the burden on limited NHS resources and help high-risk people stay at home.

"Providing this product free of charge during the pandemic will enable the NHS to adopt GDm-Health quickly and provide remote care for more pregnant women during this crucial time and hence reduce hospital visits for this high-risk group.

"We are also working closely with our NHS partners as well as our industry collaborators on modifying our existing technologies to aid remote patient monitoring and provide the authorities with additional relevant information on the pandemic."

Lucy Mackillop , Chief Medical Officer of Sensyne Health plc and consultant obstetric physician at Oxford University Hospitals NHS Foundation Trust and Honorary Senior Clinical Lecturer, Nuffield Department of Women's and Reproductive Health, University of Oxford, said: "I am pleased that GDm-Health is being deployed more broadly during this crisis to help this high-risk group receive their diabetes care safely at home. GDm-Health has made the transition to a commercial product and is already available across the NHS. This product is a result of an enormous amount of work by the clinical and academic teams at Oxford University Hospitals NHS Foundation Trust and University of Oxford and by Sensyne Health to have taken our prototype and transformed it into a sustainable scalable product."

GDm-Health has demonstrated a positive impact for mothers-to-be since its launch in August 2018. At present 20 NHS Trusts have adopted the product, with the system now live in 16 of those Trusts. The system has helped to avoid an estimated 1,312 caesarean sections and 532 pre-term births, and 780 mothers have avoided transitioning to further pharmacological treatment[1]. It also displayed the potential for cost-savings to the NHS through improved patient outcomes.

Diabetes during pregnancy refers to an intolerance of glucose during pregnancy. The condition is increasing in prevalence world-wide, driven by demographic and lifestyle changes. In the UK, the rise is predicted to reach over 16%, from a baseline of around 4% in 2008[2]. The traditional method of manually recording glucose levels on paper by the patient is time-consuming, is open to the risk of transcription errors, and does not provide clinicians with the opportunity to review changes in symptoms in real-time in order to prioritise patients at need.

GDm-Health began as a collaboration between Oxford University Hospitals NHS Foundation Trust and the University of Oxford's Institute of Biomedical Engineering. The system was invented, and clinical development led, by Dr Lucy Mackillop, a consultant obstetric physician at Oxford University Hospitals NHS Foundation Trust and Honorary Senior Clinical Lecturer in women's and reproductive health at the University of Oxford, and VP of Medical Affairs at Sensyne Health.

-ENDS-

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About Sensyne Health 

Sensyne Health plc is a clinical AI company that works in partnership with the NHS to improve patient care and accelerate the discovery and development of new medicines. Sensyne Health is listed on the AIM Market of the London Stock Exchange (SENS.L).

For more information, please visit: www.sensynehealth.com www.sensynehealth.com.

About GDm-Health™

GDm-Health is a direct patient-to-clinician blood glucose monitoring management system specifically designed for the management of diabetes during pregnancy and can be used to manage women with pre-existing diabetes. The system allows clinician review of patient-annotated blood glucose results in real time. It is based on a smartphone application that enables women to connect a blood glucose meter to their smartphone using Bluetooth or NFC (near field communication) and then automatically collecting blood glucose measurements. These measurements, along with any text-based commentary the woman wishes to record, are transmitted directly to the clinical team where they may be reviewed via a web-based software application. As a result, clinicians get more time to focus on the woman's care needs rather than collecting and recording data and have the ability to prioritise care to women most at need. The system enables at a glance oversight of the patient cohort and improves communication with the women in their care.

GDm-Health is a remote communications device that allows patients to record and share data with their healthcare team. GDm-Health does not itself provide any medical diagnosis or advice or direct patient care. Instead, it provides a patient's healthcare team with the patient's data in a more easily readable format, which facilitates the healthcare team's clinical decision-making and communication back to women under their care, as evidenced by the results presented in Mackillop L. et al, JMIR Mhealth Uhealth 2018;6(3):e71.

GDm-Health is a CE approved Class 1 medical device that complies with the essentialRequirements of the European Medical Directive and subsequent implementing legislation. GDm-Health is listed on NHS Digital's Apps Library and has been the subject of a NICE (National Institute for Health and Care Excellence) Medtech innovation briefing [MIB131].