Press release

Landmark RATULS Research Trial of Robot-Assisted Stroke Therapy Utilizes BIONIK’s InMotion Robotic Therapy Systems

Sponsored by Businesswire

Laboratories Corp
. (OTCQB: BNKL) (“BIONIK” or the
“Company”), a robotics company focused on providing rehabilitation and
assistive technology solutions to individuals with neurological and
mobility challenges from hospital to home, today announced the
completion of a landmark Robot
Assisted Training for the Upper Limb after Stroke (RATULS)
utilizing the Company’s InMotion Robotic Therapy Systems.

Results of the RATULS trial were presented at the European Stroke
Organisation Conference (ESOC) in Milan, Italy on May 22, 2019 and
published in the Lancet Online Journal on the same day. The study’s
purpose was to compare clinical effectiveness of robot assisted
training, enhanced upper limb therapy, and usual care for patients with
moderate or severe upper limb functional limitation. The RATULS trial
began in 2014 and was completed end of 2018.

“We are pleased that the RATULS trial confirmed the finding of previous
research studies which demonstrated that robot-assisted therapy improved
upper limb impairment when compared with conventional care methods for
stroke victims. The trial’s finding that robotic therapy is the only
therapy to statistically maintain a significant impairment advantage at
six months after treatment is a strong signal that robotic therapy is
critical for achieving positive patient outcomes,” said Dr. Eric
Dusseux, CEO, BIONIK Laboratories. “BIONIK’s InMotion Robotic Therapy
Systems have been selected for some of the largest interventional
research studies over the past 10 years, including the Veterans Affairs
Robotics Trial which confirmed robot-assisted therapy improvement in
upper limb impairment using the Fugl-Meyer Assessment (FMA), a
stroke-specific, performance-based impairment index. In the VA study,
the impairment advantage achieved through robot-assisted therapy
translated into significant upper limb function improvements using the
Wolf Motor Function Test.”

For the RATULS trial, the primary outcome for upper limb success was
determined by Action Research Arm Test (ARAT), with four distinct
success criteria that varied according to baseline severity, not used
previously and developed by the RATULS trial team. Although the findings
demonstrated that robot-assisted therapy improved upper limb impairment,
using this ARAT measurement, the trial was unable to conclude that
robot-assisted therapy or enhanced upper limb therapy resulted in
improved upper limb functionality after stroke compared with usual care
provided to patients with stroke-related upper limb functional
limitation. The attrition rate was also drastically reduced in patient
population following either robotic therapy or enhanced upper limb
therapy versus usual care only, and most of the withdrawals before 3
months in usual care were due to disappointment with treatment

BIONIK recognizes the difficulty of creating a level playing field for
comparing technology-assisted therapy to conventional methods and
commends Professor Helen Rogers and her UK research team for their
diligent undertaking and extensive study of 770 patients over a
four-year time period.

“We appreciate the ongoing medical study of innovative technology
designed to improve patient recovery from stroke. We are also grateful
for the extensive feedback provided by patients and clinical
practitioners over the past three years as we have actively researched
and developed improved capabilities for our robotic rehabilitation
systems,” said Dr. Dusseux. “The combination of evidenced-based medicine
and real-world clinical feedback have led to the release of
substantially improved versions of the InMotion ARMTM Robotic
Therapy System announced in early 2018, and the InMotion ARM/HANDTM
Robotic Therapy System announced beginning of 2019. These versions of
our products include enhanced software applications with patient-centric
configurable protocols to assist the therapist in providing specialized
treatment of stroke and traumatic brain injury. BIONIK looks forward to
providing the most advanced solutions to allow clinicians to develop the
appropriate rehabilitation methods to address upper limb impairment and
reduced arm function. We have seen robotic therapy utilized effectively
due to its inherent repeatability and predictability which facilitates
the standardization of treatment protocols and consistent measurement of
patient progress, another great way to reinforce the patient’s

BIONIK’s InMotion Robotic Systems have now been utilized in two of the
largest interventional trials completed for upper limb evaluation in the
past 10 years. The Company’s robotic-assisted rehabilitation
technologies were previously utilized in a trial led by the Providence
Veteran Affairs Medical Center, involving 127 patients with
moderate-to-severe upper-limb impairments six months or more after
stroke. The results of that study were published in The
New England Journal of Medicine
in April of 2010.

To read the complete RATULS study, please visit the Lancet
Online Journal

About BIONIK Laboratories Corp.

BIONIK Laboratories is a robotics company focused on providing
rehabilitation and mobility solutions to individuals with neurological
and mobility challenges from hospital to home. The Company has a
portfolio of products focused on upper and lower extremity
rehabilitation for stroke and other mobility-impaired patients,
including three products on the market and four products in varying
stages of development.

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