RXB.L Regulatory News (RXB)

Rex Bionics Plc

("Rex Bionics" or the "Company")

More Positive Data from RAPPER II

· Second Interim Analysis presented at US Military Health System Research Symposium, Florida, USA

· 96% Treatment Success and no Serious Adverse Events

· Good results for quadriplegic volunteers

· Trial to be closed down - primary and secondary end-points now met

· Final results, including Quality of Life data, to be presented in November 2016

18 August 2016: Rex Bionics Plc (AIM: RXB), the pioneer of the REX Robot technology that enhances the mobility of wheelchair users, is pleased to announce positive results from a second interim analysis of its RAPPER II clinical trial. RAPPER II is multi-centre, international trial to evaluate the feasibility and safety of the REX and of a set of customised exercises performed in a REX; and the impact on quality of life (sleep, pain and spasticity).

The data, prepared by Principal Investigator Nick Birch FRCS (Orth), were presented at the 2016 meeting of the Military Health System Research Symposium (15 - 18 August 2016) in Orlando, Florida, US on behalf of the six trial sites - three in the UK, two in New Zealand and one in Australia.

The results of the second interim analysis are consistent with the first interim analysis - and show that REX can safely be used by people with spinal cord injury. 51 out of 53 volunteers (96%) were able to complete the transfer-walk-exercise protocol ("Treatment Success") - the primary endpoint of the trial. There were no Serious Adverse Events.

15 volunteers were Quadriplegic, with 38 Paraplegic, and the results were essentially the same. This confirms that the benefits of the REX technology are available to people with more severe injuries, in the Cervical 4-7 range in the spinal column; and in other cases of severe neurological impairment.

95% of the volunteers questioned said they would like to use REX on a weekly basis.

With 53 volunteers, RAPPER II is the largest trial to date of a mobile robotic mobility aid.

The investigators have now agreed that, in view of the strength and clarity of the data, the trial should be closed. The final steps for RAPPER II are the presentation of the Quality of Life data at the American College of Rehabilitation Medicine's 93rd Annual Conference (30 October - 4 November 2016) in Chicago, Illinois, US; and the publication of the trial results in a peer-reviewed journal, expected in 2017.

The next phase of the REX clinical strategy has two elements - the design of trials that show that REX has a definitive medical benefit for people with spinal cord injury, and with the consequent economic benefit; and the establishment of trials in other indications, for example - Multiple Sclerosis, Muscular Dystrophy and Traumatic Brain Injury. The announcement of the initiation of at least one new trial is expected before the end of 2016.

Rex Bionics' mission is to establish Robot-Assisted Physiotherapy as a Standard of Care for people with neurological injury or illness.

Nick Birch, FRCS (Orth), the Principal Investigator on the trial, commented: "The results of the RAPPER II trial exceeded the clinical teams' expectations and justify consideration of REX by the many wheelchair users who look for new technology that can help them manage their life with neurological injury or illness."

Crispin Simon, Chief Executive of Rex Bionics plc added: "I am delighted by these positive results. They are a strong message to those philanthropists who are considering donating a REX to their local rehabilitation centre; and to insurance and tax-funded healthcare systems.

"I'm looking forward to seeing the Quality of Life data later in the year. Further positive results would confirm that REX is not just about standing and walking - great though that is - but that it has a therapeutic effect."

A copy of this announcement has been posted on the Company's website at www.rexbionics.com/.

For further information please contact:

Rex Bionics Plc

Crispin Simon, Chief Executive Officer

+44 (0) 781 086 6386

Peter Worrall, Chief Financial Officer

+44 (0)1428 645416

Stifel Nicolaus Europe Limited (NOMAD and Broker)

Jonathan Senior/ Stewart Wallace / Ben Maddison

+44 (0) 20 7710 7600

Consilium Strategic Communications

Mary-Jane Elliott / Chris Welsh

rexbionics@consilium-comms.com

+44 (0) 203 709 5700

About the Military Health System Research Symposium (MHSRS)

The MHSRS is the US Department of Defense's premier scientific meeting. It is a venue for communicating and discussing new scientific knowledge resulting from military-unique research and development. It is the only military or civilian meeting that focuses specifically on the unique medical needs of the Warfighter.

The MHSRS provides a scholarly forum for the planning and development of future studies aimed at optimizing care for members of the Uniformed Services in operational settings. Held in a collaborative, joint setting, it enables military medical care providers with deployment experience to exchange information with Department of Defense and academic scientists, international partners, and industry on research and related health care initiatives falling under the topic areas of Combat Casualty Care, Military Operational Medicine, Clinical and Rehabilitative Medicine, and Military Infectious Disease. Its goal is to maximize research synergy among all of the branches of military service, while acknowledging the need for service-specific medical capabilities.

The MHRS is an annual event that is sponsored by the Assistant Secretary of Defense for Health Affairs.

About Rapper II

RAPPER II (Robot-Assisted Physiotherapy Exercises with REX) is a trial to evaluate the feasibility and safety of the REX and of a set of customised exercises performed in a REX; and to collect preliminary data on the impact on quality of life.

The trial entails a single visit to the REX clinic, consisting of a walk test and a set of exercises, with feasibility and safety recorded during the visit; and, for the final cohort of volunteers, quality-of-life measures and further safety recorded at two-day follow-up. The Quality of Life measures are The Universal Pain Assessment Tool, The Standardised Health Outcome Measure (EQ-5D), The Sleep Disturbance - Short Form Questionnaire and the Spinal Cord Injury Spasticity Evaluation Score.

Six clinics in three countries have participated in the trial: in the UK, Physiofunction Ltd at the Chris Moody Centre, near Northampton; the Royal National Orthopaedic Hospital NHS Trust, Stanmore; and East Kent Hospitals University NHS Foundation Trust, Canterbury; in Australia at Austin Health: Royal Talbot Rehabilitation Centre, Melbourne; and in New Zealand at the Auckland University of Technology; and the Burwood Academy of Independent Living, Christchurch.

The trial was not designed with a specific regulatory focus as REX is already registered for use in the EU, the US and many other parts of the world. The trial is monitored by an independent Clinical Research Organisation. Details can be found at: https://clinicaltrials.gov/show/NCT02417532 .

Data from the first interim analysis of 20 volunteers were presented by Dr Andrew Nunn MBBS, FAFRM (RACP), Medical Director, Victorian Spinal Cord Service, Austin Health: Royal Talbot Rehabilitation Centre, Melbourne, Australia, at the Australian and New Zealand Spinal Cord Society (ANZSCoS) Annual Meeting, Perth, Western Australia on 27 November, 2015.

About Rex Bionics Plc

Rex Bionics (AIM: RXB) is the pioneer of the REX Robot that enhances the mobility of wheelchair users and was founded in Auckland, New Zealand by two robotics engineers with first-hand experience of wheelchair users and their needs. 

Rex Bionics is working with physiotherapists to develop the concept and practice of Robot-Assisted Physiotherapy (RAP). In a session of RAP, REX lifts patients from a sitting position into a robot-supported standing position, allowing them to take part in a set of supported walking and stretching exercises, designed by specialist physiotherapists. 

In addition, REX P, for use in the home, enables users to walk and stand with their hands free - providing more work and recreation options. Our vision is to commercialise an all-day use REX P for a target market segment of wheel chair users with a spinal cord injury, who number around 500,000 people in the US and EU alone. The market potential for this new category of robotic mobility aid was recently estimated to be $2.1 billion in 2021, by Wintergreen Research Inc.

Wheelchair users are at risk of developing numerous medical complications from extended periods of sitting. By enabling them to spend more time standing, walking and exercising, REX may offer significant health benefits, including improved sleep and maintenance of joint range, and a reduction in spasm, pain, common abdominal problems and prescription drug use.

A program of "RAPPER" clinical trials is now under way to evaluate these potential benefits and the first and second interim analysis of the RAPPER II data were presented on 27th November 2015 and 17th August 2016 respectively.

Until now, REX has most commonly been used by wheelchair users with a spinal cord injury, but has also been used by people who have suffered a stroke or other traumatic brain injury; and wheelchair users with multiple sclerosis, muscular dystrophy and cerebral palsy.

Rex Bionics has three Strategic Objectives - to establish Robot-Assisted Physiotherapy as a Gold Standard of Care for Spinal Cord Injury, Stroke and other neurological conditions; to establish REX as the market-leading robotic mobility aid; and by effective execution of our plans, to deliver significant value growth to shareholders. 

Rex Bionics works with distribution partners in the US (customerservice@enableme.com), China (MAAB, alex.lou@maab-group.com), Hong Kong and Taiwan (Deltason, tommychan@deltason.com), Denmark and Belgium; and in other countries we support customers directly (info@rexbionics.com). 

Rex Bionics was admitted to trading on the London Stock Exchange's AIM in 2014. REX is not registered for At-Home use in the United States of America.