SENS.L Regulatory News (SENS)

Sensyne Health launches first digital health product in the U.S.

Oxford, U.K. 15 December 2020: Sensyne Health plc (LSE: SENS) ("Sensyne" or the "Company" or the "Group"), the British Clinical AI technology company, today announces that it has launched GDm-Health, its remote monitoring solution for diabetes in pregnancy, in the U.S. with immediate effect.

Sensyne's sales and marketing partner for the U.S., Cognizant, is now offering the solution to U.S. health systems and health plans via its sales force. Virtual care services powered by GDm-Health will qualify for reimbursement under remote patient monitoring codes introduced by the Centers for Medicare and Medicaid Services (CMS) in 2020.

Diabetes in pregnancy is a common condition that can increase the risk of hypertension and caesarean section in mothers as well as preterm birth, birth trauma and admission to neonatal intensive care for newborn babies. Over 20%[1] of pregnancies in the U.S. are affected by diabetes every year. GDm-Health has the potential to significantly improve the way this treatable condition is managed by doctors in collaboration with their patients.

The U.S. launch of GDm-Health follows results from a randomised controlled trial conducted in the U.K. which demonstrated a reduction in caesarean sections, improvements in blood glucose monitoring adherence and higher satisfaction with care in women using GDm-Health.

GDm-Health has demonstrated strong demand in the U.K., achieving a 47% market share across NHS England. It has been adopted by 50 NHS Trusts across the NHS with a further 7 Trusts in the process of going live.

Sensyne is concluding a pilot of GDm-Health at Jefferson Health, one of the fastest growing health systems in the U.S., comprising 14 hospitals with 2,800 beds, 6,000 physicians and 7,000 nursing staff with 18,000 births a year. Results from the pilot are expected to be reported in a peer-reviewed journal in early 2021.

The roll out of the product in the U.S. will be led and overseen by Derek Baird who was recently appointed as Sensyne's President, North America, and is responsible for driving the commercial development of the Company's North American operations, building Sensyne's presence in the U.S. and recruiting a U.S.-based business development team to work in collaboration with the Cognizant sales force.

Lord (Paul) Drayson PhD, CEO of Sensyne Health, said:

"This marks another major milestone in Sensyne's development. The launch of GDm-Health in the U.S. market was a key objective for the Company in this financial year. Entering the U.S. market will help pregnant women and clinicians in the U.S. manage diabetes in pregnancy, improving outcomes for both mothers and babies. We are very pleased to be partnered with Cognizant and benefit from their significant sales force behind our initial launch. We look forward to the publication of the study conducted by Jefferson Health to add further weight to the benefits of the GDm-Health product."

Derek Baird, President, North America of Sensyne Health, said:

"There's no debating the U.S. healthcare system must do better to support maternal and infant health. GDM-Health, as a clinically validated solution with proven results, will address one of the key issues: effective management of diabetes in pregnancy. Given the increased reimbursement support for remote patient monitoring and the desire for fewer in-person visits, the timing is right for launch now. We're thrilled to make GDM-Health the first formal U.S. product launch and I look forward to more to come."

-ENDS-

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About Sensyne Health (www.sensynehealth.com)

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).

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 and 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].