· 95% Treatment Success and no adverse events
· 95% of volunteers said they would like to use REX on a weekly basis
· Next new RAPPER II sites will be the Royal National Orthopaedic Hospital NHS Trust, Stanmore, UK; and Austin Health: Royal Talbot Rehabilitation Centre, Melbourne, Australia
27 November 2015: 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 an interim analysis of its RAPPER II clinical trial. RAPPER II (Robot-Assisted Physiotherapy Exercises with REX) is a trial to evaluate the safety and feasibility of a set of customised exercises performed in a REX. This first phase of RAPPER II entailed a single visit to the REX clinic, consisting of a walk test and a set of exercises, with immediate post-experience follow-up.
The interim analysis of the data, based on results from the first 20 volunteers, shows that REX can safely be used by people with spinal cord injury. 19 out of 20 volunteers (95%) were able to complete the walk exercise protocol (“Treatment Success”) – the primary endpoint of the trial. There were no Serious Adverse Events and no treatment-related Adverse Events. 95% of the volunteers said they would like to use REX on a weekly basis.
The trial has not been 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
The data 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.
Presenting the interim data, Dr Nunn concluded: “REX is a safe Powered Walking Aid – providing a viable exercise option with a minimal training requirement and positive user feedback.”
Nick Birch, FRCS (Orth), the Principal Investigator on the trial, commented: “These are good results and we are particularly encouraged by the confidence shown by users with cervical level – or relatively severe — injuries. The data are consistent with the feedback that I have been getting from my own patients.”
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.
“With the additional questionnaires and the seven day follow-up, positive results from the next Interim Analysis would confirm that REX is not just about standing and walking – great though that is – but also that there is also a therapeutic effect for people who live with spinal cord injury.”
Key points from the study:
· 19 out of 20 volunteers (95%) were able to complete the walk/exercise protocol, the primary end-point of the trial. One volunteer was able to complete the transfer and a part of the exercise regime, but was not able to complete the walk/exercise protocol because of a spinal deformity that was not a cause for rejection at screening. This was recorded as a treatment failure.
· There were no Serious Adverse Events and no treatment-related Adverse Events. There was one incidence of spasm, not considered to be caused by the treatment.
· All of the volunteers who completed the treatment responded to a 16-item questionnaire – on a seven point scale of Strongly Disagree, through neutral to Strongly Agree1. The questions were phrased in the positive; and positive scores below represent answers in any one of three categories of Agree.
o The scores for 15 out of the 16 questions were clearly positive. The only negative score was recorded in response to the question, “I found it easy to transfer into the REX”, to which 47% agreed and 47% disagreed; with one response of “Neutral”. Prior use of REX was an exclusion criteria, so the volunteers had no prior learning or training. REX users will self-evidently only ever be first time users on one occasion.
o 84% of all the volunteers’ answers to all of the questions were positive.
o In addition, where the volunteers agreed with a question, there was a clear tendency to “Strongly Agree”, (rather than less emphatic versions of Agree) accounting for 54% of the total answers – more than the other six possible answers combined.
o 100% of volunteers could “see the benefits of using REX regularly”; 95% “would like to use REX on a weekly basis”; and 79% of volunteers “felt a sense of wellness after using REX”. This pattern suggests that REX will be able to deliver the proven benefits to wheel chair users of standing and walking, and will be important support to take to reimbursement agencies.
o Questions relating to Confidence, Safety, Stability, Comfort and Ease of Control of REX were in the 84-95% positive range.
o Questions relating to Size, Sound and Speed of REX were in the 68-79% positive range.
o The answers to the other five questions covering the wider utility of REX were in the range of 79% to 95% positive.
· The mean time from transfer to mobilisation was seven minutes; and in less than ten minutes all the users were able to use the joystick to control the REX. This – the brevity and simplicity of the training required for use of the REX – will also be presented as supportive evidence to reimbursement agencies.
· 15 volunteers had injuries at the thoracic level (relatively low and so, paraplegic) and five had injuries at the cervical level (relatively high and so, tetraplegic) with a concomitantly greater level of disability.
In addition, a number of users have reported that the REX exercise regime has provided them with relief from pain, spasm and sleeplessness for several days and nights. For the next phase of the trial, the investigators have therefore added end-points of four validated questionnaires – 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 – with follow-up at seven days to gather data on the duration of the potential treatment effect. This will provide additional evidence for healthcare assessment authorities.
A second Interim Analysis will be prepared on the next cohort of 20 patients with the new questionnaires and a seven day follow-up. These results will be presented in the first half of 2016.
Dr Nunn and colleagues at Austin Health, Melbourne, Australia will be joining the RAPPER II trial and expect to recruit the first volunteer before the end of the year. The Royal National Orthopaedic Hospital NHS Trust, Stanmore UK, a world leader in rehabilitation medicine and a research partner of University College London (UCL), will also become a trial site. Three other sites in the UK and New Zealand are also working through the trial application regulatory process.
For further information please contact:
Rex Bionics Plc
Crispin Simon, Chief Executive Officer
+44 (0) 748 3 167851
Peter Worrall, Chief Financial Officer
+44 (0) 142 864 5416
Stifel Nicolaus Europe Limited (NOMAD and Broker)
Jonathan Senior/Stewart Wallace
+44 (0) 20 7710 7600
Consilium Strategic Communications
Mary-Jane Elliott / Jessica Hodgson / Chris Welsh / Lindsey Neville
+44 (0) 203 709 5700
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 500,000 in the US and EU.
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 programme of “RAPPER” clinical trials is now under way to evaluate these potential benefits and a positive interim analysis of the RAPPER II data was presented on 27th November 2015. Recruitment for RAPPER II remains open and clinics and individuals can send enquiries to firstname.lastname@example.org.
REX has, until now, been most commonly used by wheel chair users with a spinal cord injury, but has also been used by people who have suffered a stroke or other traumatic brain injury; and wheel chair 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 (email@example.com), China (MAAB, firstname.lastname@example.org), Hong Kong and Taiwan (Deltason, email@example.com), Denmark and Belgium; and in other countries we support customers directly (firstname.lastname@example.org).
Rex Bionics listed on the London Stock Exchange’s AIM in 2014. REX is not registered for At-Home use in the United States of America.
1. The questionnaire used the Likert scale – a psychometric test commonly involved in research that employs questionnaires. When responding to a Likert questionnaire item, respondents specify their level of agreement or disagreement on a symmetric agree-disagree scale for a series of statements