TIDMRXB
Rex Bionics PLC
07 November 2016
Rex Bionics Plc
("Rex Bionics" or the "Company")
REX Clinical Trial shows potential for improved sleep for
patients with Spinal Cord Injury
-- Quality of Life Analysis presented at ACRM conference in Chicago
-- Six out of eight sleep indicators show improvement after a single treatment
-- Equivalent results between paraplegic and quadriplegic volunteers
7th November 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 final
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.
The results were presented by Principal Physiotherapy
Investigator, Jon Graham BA, MSc, MSCP at the 93(rd) annual meeting
of the American Congress of Rehabilitation Medicine, Chicago
Ill.
The analysis focused on the sleep questionnaire, with responses
collected before and after a single treatment with REX. In six out
of the eight statements, the responses indicated an improvement in
sleep reduction, suggesting a beneficial exercise-induced fatigue.
The greatest improvement was seen in relation to the proposition "I
felt physically tense at night", where there was a 90% improvement
in the mean score of all respondents. The next greatest
improvements were seen in "I had trouble stopping my thoughts at
bed-time"; and "Pain woke me up".
The trial's 18 tetraplegic patients achieved essentially the
same results as the 38 paraplegic patients. This confirms that the
benefits of the REX technology are available to people with more
severe injuries - including those in the upper to mid cervical
range in the spinal column. No clear trends were discernible in the
pain and spasticity questionnaires that were also used. These
questionnaires will be used again in future trials, where there
will be not just a single treatment, as in RAPPER II with its focus
on safety and feasibility, but with a full course of REX treatment
with a therapeutically meaningful frequency and duration. 94% of
the volunteers questioned said they would like to use REX on a
weekly basis.
The investigators agreed in August 2016, that in view of the
strength and clarity of the data, recruitment to the trial should
be closed. The final step for RAPPER II is 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 a trial in spinal cord medicine to show that REX has
a significant and cost-justifiable medical benefit when used in a
prescribed course of treatment; and the establishment of trials in
other indications, for example - Multiple Sclerosis and Muscular
Dystrophy. A trial was recently initiated in Australia for patients
with stroke and traumatic brain injury.
Rex Bionics' mission is to establish Robot-Assisted
Physiotherapy - in the clinic and at home - as a Standard of Care
for people with neurological injury or illness.
Nick Birch, FRCS (Orth), the Principal Investigator of the
trial, commented: "The many patients with neurological injury and
illness who experience sleep deprivation as a result of pain, will
be very encouraged by these results."
Crispin Simon, Chief Executive of Rex Bionics plc added: "RAPPER
II has gone according to plan. We have strong safety and usability
results; and trends in the quality of life data that are consistent
with the positive feedback that we get from patients."
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 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 or
seven-day follow-up.
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.
Data from the second interim analysis were presented in August
2016 at the US Military Health System Research Symposium and showed
that REX can safely be used by people with spinal cord injury. 52
out of 56 volunteers (93%) were able to complete the
transfer-walk-exercise protocol ("Treatment Success") - the primary
endpoint of the trial. There were no Serious Adverse Events.
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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