TIDMRXB
Rex Bionics PLC
23 January 2017
Rex Bionics Plc
("Rex Bionics" or the "Company")
REX initiates RAPPER III: Clinical Trial in Multiple
Sclerosis
-- Ethics Committee Approval from NHS's National Institute for Health Research (NIHR)
-- Partnership with East Kent Hospitals University NHS Foundation Trust, and Kent University
23 January 2017: Rex Bionics Plc (AIM: RXB), the pioneer of the
REX Robot technology that enhances the mobility of wheelchair
users, Rex Bionics Plc (AIM: RXB), the pioneer of the REX Robot
technology that enhances the mobility of wheelchair users, is
pleased to announce that the ethics committee of the UK NHS's
National Institute for Health Research has approved the start of a
clinical trial to evaluate the use of the REX robotic mobility
device in patients with multiple sclerosis (MS). The trial will be
conducted at the Canterbury site of the East Kent Hospitals
University NHS Foundation Trust under the direction of Dr Mohammed
Sakel, Consultant and Director of the Neurorehabilitation
service.
The intent is to evaluate the feasibility and safety of using
the REX Robot in rehabilitation for people with MS who have
moderate to severe mobility restriction. The trial, known as RAPPER
III, will recruit ten people with a primary diagnosis of MS and an
Expanded Disability Status Scale (EDSS) score of between 6 (defined
as "requires a walking aid to walk about 100m") and 7.5 (defined as
"Unable to take more than a few steps. Restricted to wheelchair and
may need aid in transferring").
The primary end-point of the trial is the completion of a
transfer, stand, balance and walk rehabilitation programme over six
weeks. The aim of the programme is to increase strength, improve
balance-related skills and walking ability. There are a number of
secondary end-points, including the Multiple Sclerosis Walking
scale (MSWS-12) and the Multiple Sclerosis Impact scale
(MSIS-29).
The first patient is expected to be recruited shortly, with
preliminary data presented later in 2017.
Dr Mohammed Sakel, the Principal Investigator of the trial,
commented: "We are optimistic about the REX's potential for
benefitting patients with multiple sclerosis. I am delighted to see
the enthusiasm of our MS patients and the Charity Kent MS Therapy
Centre"
Crispin Simon, Chief Executive of Rex Bionics plc added: "Our
RAPPER II trial established the safety and feasibility of the REX
in a single treatment. We are delighted that the specialists in
Canterbury are now interested in exploring the use of REX in MS,
and in a course of treatment over several weeks."
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 / Jessica Hodgson / Lindsey
Neville
rexbionics@consilium-comms.com
+44 (0) 203 709 5700
About MS
MS is a chronic inflammatory - demyelinating disease of the
central nervous system (CNS) leading to progressive impairment of
function. MS is diagnosed in 3.5 to 6.6 people per 100,000 of the
population each year, equivalent to about 1,800 to 3,400 people
year in England and Wales. Prevalence is equivalent to about 52,000
to 62,000 people. Some people with MS develop few symptoms, but for
others the disease and society's interactions with them lead to
problems affecting all aspects of their lives. NICE Guidelines
recommend all patients with MS should have access to specialist
Neurorehabilitation services.
Balance is often compromised by the inflammatory process which
can also impact on motor and sensory nerve pathways causing reduced
muscle power, co-ordination, walking and functional abilities. It
is estimated that 15 years after disease onset, 15% of MS patients
need technical aids for walking and 29% use a wheelchair. The
reduction in mobility stems from various factors including weakness
of muscles, spasticity, impaired balance, falls and fear of
falls.
The Multiple Sclerosis Foundation estimates that more than
400,000 people in the United States and about 2.5 million people
around the world have MS. Between 2008 and 2012, the cost of drugs
for the treatment of MS in the US doubled from $4 billion to nearly
$9 billion annually. The annual cost for the gold standard
interferon therapy is around $60,000.
About the RAPPER Trial Programme
Rex Bionics' mission is to establish Robot-Assisted
Physiotherapy as a fully-reimbursed standard of care for clinic and
home use for a range of neurological conditions. RAPPER III is part
of a programme of trials delivering the evidence to support the
mission.
RAPPER I (Robot-Assisted Physiotherapy Exercises with REX) was a
small feasibility study conducted in the UK.
RAPPER II is a trial to evaluate the feasibility and safety of a
set of customised exercises performed in a REX in a single session
by users with spinal cord injury. Data from the second interim
analysis were presented on 3(rd) November 2016 at the American
College of Rehabilitation Medicine (ACRM) and showed that 52 out of
56 volunteers (93%) were able to complete the
transfer-walk-exercise protocol - the primary endpoint of the
trial. Sleep, Spasticity and Pain metrics were positive and there
were no Serious Adverse Events.
RAPPER III is a trial to evaluate the feasibility and safety of
using the REX Robot in rehabilitation for people with MS who have
moderate to severe mobility restriction. The trial will recruit ten
patients. The primary end-point is the completion of a transfer,
stand, balance and walk rehabilitation programme over six weeks.
The aim of the programme is to increase strength, improve
balance-related skills and walking ability. There are a number of
secondary end-points, including the Multiple Sclerosis Walking
scale (MSWS-12) and the Multiple Sclerosis Impact scale
(MSIS-29).
About Rex Bionics Plc
Rex Bionics is the pioneer of the "REX" that provides robotic
standing, walking and exercise support for wheelchair users; and
was founded by two British engineers with first-hand experience of
the needs of wheelchair users. REX is used by people who have
suffered a spinal cord injury, stroke or other traumatic brain
injury; and people with multiple sclerosis, muscular dystrophy and
cerebral palsy.
We are working with physiotherapists to develop the concept and
practice of Robot-Assisted Physiotherapy (RAP); and also offer REX
P, for use in the home, enabling customers to walk and stand with
their hands free - providing more work and recreation options.
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.
Our commitment to engineering excellence is complemented by a
commitment to clinical science and the RAPPER II clinical trial
results show high levels of practicality, safety and user
enthusiasm.
Our Vision is that every day, around the world, thousands of
people get relief with REX, from the harm - the pain, discomfort
and inconvenience - of neurological accidents and illnesses; and
that many will be cured.
This information is provided by RNS
The company news service from the London Stock Exchange
END
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