Brand new Bionic legs go ahead with trials! Could you take part?

Rex Bionics Plc


(“Rex Bionics” or the “Company”)


First Patient Treated in RAPPER II Clinical Trial


1 June 2015 Rex Bionics Plc (AIM: RBX), the pioneer of the REX Robot technology that enhances the mobility of wheelchair users, is pleased to announce that the first patient has been successfully treated in its RAPPER II ("Robot-Assisted PhysiotheraPy Exercises with REX") clinical trial.


A 37 year-old male with a spinal cord injury at level T3, and no prior experience with REX, mobilised the REX in less than four minutes and completed the prescribed set of exercises.


RAPPER II is a 100 patient study designed to measure time taken for wheelchair users to mobilise in a REX, exercise regimen completion and the severity of injury that can safely be treated with a REX. The participants are wheelchair users with a spinal cord injury. As a multi-centre, international trial, monitored by an independent clinical research organisation and registered with clinicaltrials.gov, RAPPER II is designed to operate to the highest clinical research standards.


During Robot-Assisted Physiotherapy (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. One visit per patient will be sufficient to complete each patient's participation in the trial.


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. Wheelchair users who would like to be considered for participation in the trial should contact rex@physiofunction.co.uk. PhysioFunction, the first trial site, near Northampton, will be able to treat volunteers, free-of-charge, from all over the UK as well as from overseas, provided they meet the trial inclusion criteria.


RAPPER II received ethics committee approval from the NHS National Institute of Health Research in mid-May; and the company expects to add further sites, in the UK and overseas, in the coming weeks. The trial investigators intend to present data from the first cohort of patients at a medical conference before the end of 2015.


Nick Birch, MBBS FRCS (Orth), Consultant Orthopaedic Surgeon and the RAPPER II Principal Investigator, commented: “We very much welcome the start of this trial. Patients with a severe spinal cord injury generally have poor exercise and recreation options and the REX is a very promising new technology.”


The Spinal Injuries Association (SIA), the UK charity providing support and information for spinal cord injured community, is helping to raise awareness of the trial.


Crispin Simon, Chief Executive of Rex Bionics, commented: “This is an important milestone for REX and I'd like to thank all the people on the team who have helped to get the trial started; and thank the trial volunteers for their role in helping us to develop the technology for the benefit of current and future wheelchair users.”


RAPPER I


In February 2015, the Company announced preliminary data from RAPPER I, a registry of 11 wheelchair-dependent patients who were studied to assess the feasibility of carrying out sophisticated physiotherapy in the REX. The level of neurological impairment ranged from C4 to T10 (four quadriplegic and seven paraplegic patients). All study participants were able to complete the prescribed exercises and achieve competency in using the REX with the joystick. There were no adverse events. More detail on the trial will be presented at medical conferences in the next few months.


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/Giles Balleny
+44 (0) 20 7710 7600


Consilium Strategic Communications
Mary-Jane Elliott / Jessica Hodgson / Chris Welsh / Lindsey Neville
rexbionics@consilium-comms.com
+44 (0) 203 709 5700


About Rex Bionics Plc


Rex Bionics (AIM: RXB) is the AIM-listed pioneer of the REX Robot that enhances the mobility of wheelchair users. 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 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.
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, cardiovascular performance, maintenance of joint range, and a reduction in common abdominal problems and prescription drug use. A programme of clinical trials is now under way to evaluate these potential benefits.
REX is used by people with complete spinal cord injury, as well as people who have suffered a stroke or other traumatic brain injury; and people with multiple sclerosis and muscular dystrophy. REX P, for use in the home, enables users to walk and stand with their hands free – providing more work and recreation options.
In May 2014, Rex Bionics joined AIM with a fundraising of £10 million (gross) to scale up production, distribution and marketing internationally, in order to support growing demand for both REX products as well as developing the next generation of REX devices, REX 3.
The use of REX in the home is not approved in the United States of America.

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What an amazing machine. Isn't technology amazing? Even though it is still in the early stages it is still an amazing mobiliser.  Although the user cannot use it 24/7 yet or walk very far, I was instantly aware of how much it still changed the user's life. Less risk of deep vein thrombosis, less risk of lung and respiratory problems, better digestion, less risk of developing pressure sores to name but a few. All this improvement on the user's health and that is before they even attempt to walk. How great is that? Sometimes we don't realise the whole impact on a paralysed person's life. Their injuries tend to be taken at face value in that we know they have no sensation and are therefore unable to move part or parts of their body. The areas we don't see that can be compromised such as digestion or developing blood clots in veins (DVTs) often go unnoticed until they cause a problem. The great thing is that with the Rapper outfit these problems and many others could be a thing of the past because it is allowing us to do the simple things of life - standing up and walking, thus helping the circulation and building flaccid muscles back up among other things.

The one outstanding thing I saw in Sophie Morgan's face (the lady who was trialing the outfit) was sheer happiness. She was beaming with delight because she could once again stand up and walk even though it is just the early stages for this aid. I can imagine the self esteem boost the wearer must get not to say the excitement of what the future holds.  

Hi Ailsa,

On top of the technological advances I especially love the medical leaps being made that sort of hint at a not too distant future where spinal cord injury could be not only treated but ultimately cured.

Scientists in the USA have recently managed to plant cells into rats with spinal damage. this caused the spine to essentially reconnect with the brain and signals being sent back and forth.

And then there's this Polish man, Darek Fidyka, who underwent revolutionary surgery and has gone from being paraplegic to being able to walk! He still needs a frame and can't exactly walk fast or far, but still the difference it must make will be phenomenal.

The doctor behind that particular surgery said he honestly considered it an even bigger and more important scientific achievement that putting a man on the moon. And it leaves me full of anticipation for future generations. Will certain disabilities simply be eradicated by the time the 22nd century kicks in?

I totally agree with you, Paul. The best is yet to come and as you say, "not in the too distant future".

It's astounding how far we have come. As an x-nurse I am able to look back at breakthru medicine before some of the techy stuff and remember how amazed we all were with being able to extend people's lives. Now we have longevity it is time to make sure people can enjoy a long life. It's no use being 90+ if you can't move,  speak, see or hear. So along come people who have incredible ideas on how to make life more liveable. The list of breakthrough medicine is endless. From cochlear implants to various transplants. The hours of physiotherapy which did not always reap any benefit, especially for those with spinal cord injuries can now stand aside as computer chips take up the challenge. Now medical application for 3D printing is expanding rapidly. Who would have thought that materials such as plastic, metal, ceramics, powders, liquids, or even living cells could be used in a 3D printer to produce custom made anatomical structures along with everything else 3D printing can achieve. The mind boggles!

I imagine disabilities caused by injury may well be eradicated by the 22nd century. Perhaps by that time they will have programmed nanomites to go to the source of the injury and mend it. I also imagine that gene therapy will have eradicated most if not all disabilities caused by disease. My worry with messing around with peoples genes is that scientists will inadvertently cause some other problem.

I only wish I could be around to see all these wonderful breakthroughs

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