Ixico Regulatory News (IXI)

19 October 2016

IXICO plc

("IXICO" or the "Company")(Ticker: IXI)

IXICO presents approach to regulatory compliant wearables at regulatory workshop in Washington

IXICO, the brain health company, is pleased to announce that Derek Hill, Chief Executive, is giving an invited talk and joining an expert panel at The Coalition Against Major Diseases (CAMD) regulatory workshop on 19th October 2016 in Washington, USA, alongside representatives of the pharmaceutical industry and regulators from the FDA, EMA and PMDA.

Derek Hill will be presenting the challenges associated with the inclusion of wearable biosensors in pharmaceutical company sponsored clinical trials, and discussing how IXICO is addressing these challenges through its ongoing biosensor programmes. He will be highlighting the issues in relation to ethics, privacy and security, data validation and ensuring clinical meaningfulness of data.

IXICO is collaborating with Withings/Nokia Digital Health on implementation of their devices in a regulatory compliant environment, and has established a collaboration addressing the correct clinical interpretation of biosensor sleep data with Professor Yves Dauvilliers of the Sleep Medicine Centre at Centre Hospitalier Universitaire de Montpellier, France.

Derek Hill will be presenting some of IXICO's initial data from healthy elderly subjects and patients with dementia and Parkinson's disease recruited from hospitals in France and the UK, including from the previously announced Cygnus project, to illustrate the potential of biosensors to impact drug development.

Derek Hill, Chief Executive officer, IXICO, commented: "Biosensor technologies are set to revolutionise drug development and patient care when used in the appropriate clinical context and regulatory framework. IXICO is delighted to share our cutting-edge work with regulators and experts from the pharmaceutical industry. "

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About IXICO

IXICO's innovative and proprietary digital healthcare technologies help those involved in researching and treating serious diseases to capture and analyse clinical data to make rapid, informed decisions. In clinical research this includes the phenotyping of patients, quantification of disease pathology and measurement of patient outcomes. In clinical practice the mobile health and digital decision support technologies aid diagnosis, patient engagement and monitoring. IXICO is also collaborating with partners to develop companion digital health products targeted at improving patient outcomes.

The Company's brain health focus includes Alzheimer's disease, Huntington's disease, multiple sclerosis, Parkinson's disease and mental health disorders.

More information is available on www.ixico.com

About Cygnus:

Cygnus is a two year project sponsored by IXICO and funded by Innovate UK. It brings together four Mental Health Trusts in the North of England, the Northern Health Science Alliance (NHSA), IXICO and the International Consortium for Health Outcomes Measures (ICHOM). The project is the first implementation of the recently published ICHOM dementia standard dataset.

The project aims to enrol 500 participants: patients referred to Memory Assessment Services at the participant Trusts with suspected dementia and their caregivers.

Key objectives of the Cygnus study are:

· To evaluate the feasibility of web-based, mobile and wearable technologies as a means to collect high quality and actionable data from patients and their care givers;

· Linking these measurements to data about outcomes and episodes of care;

· To provide a well-characterised population who have consented to contact about future evaluation of technologies and interventions that might benefit patients and caregivers.

More information is available on www.ecygnus.com