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First Patient Treated in RAPPER II Clinical Trial

1st Jun 2015 07:00

RNS Number : 7349O
Rex Bionics PLC
01 June 2015
 

 

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 [email protected]. 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

[email protected]

+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.

For more information please visit, www.rexbionics.com

 

 

 

This information is provided by RNS
The company news service from the London Stock Exchange
 
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