In EnglishQUEBEC, Oct. 16 /CNW Telbec/ - Victhom Human Bionics Inc. (Victhom, TSX:
VHB) announces today that it has received a "no objection" letter from the
U.K. Medicines and Healthcare products Regulatory Agency ("MHRA") to begin the
clinical investigation of the Neurostep(TM) in the U.K.
The Neurostep(TM) is the first fully implantable product designed to
treat, through neuromodulation, gait disorders (e.g., foot drop) which can
result from a lesion of the central nervous system caused by conditions such
as stroke and multiple sclerosis. There are more than 1,400,000 new cases of
stroke per year worldwide and approximately 20 to 30% of these patients will
develop symptoms of foot drop. The Closed-Loop System of the Neurostep(TM)
allows the combination of the sensing and stimulating features to widen the
scope of therapeutic possibilities as compared to conventional technologies
that use stimulation only.
Mr. Nader Kameli, COO of Victhom's Neurobionix business unit, stated that
the start of the clinical investigation was conditional upon receipt of the
Research Ethics Board (REB) approval of the clinical site where the
investigation will be conducted. He added that the response from the REB was
expected later this month. He also commented that with the previously
announced Investigational Testing Authorization from Health Canada, the
company was now ready to launch its multicenter clinical trial for its
Neurostep(TM).
Mr. Benoit Huet, President and CEO, stated the importance of this
clinical trial for the Neurostep(TM) and added that these results should
provide to Victhom a solid proof of concept on the Closed-Loop System and the
Neurocuff(TM), which could lead to the development of new exciting
indications.
About Victhom
Victhom discovers, develops and manufactures bionic devices involved in
the treatment of a variety of physical and physiological dysfunctions.
Victhom's Neurobionix business unit focuses on the development and
commercialization of technologies and products involving implantable devices
that feature neurosensing and neurostimulation components, integrated with
artificial intelligence. Victhom's Biotronix business unit develops
biomechatronic products to support or replace peripheral limbs in what is
known as the orthotics and prosthetics market.
FORWARD-LOOKING STATEMENTS
Some of the statements made herein may constitute forward-looking
statements. These statements relate to future events or our future financial
performance and involve known and unknown risks, uncertainties and other
factors that may cause Victhom's actual results, performance or achievements
to be materially different from those expressed or implied by any of Victhom's
statements. Actual events or results may differ materially. We disclaim any
intention, and assume no obligation, to update these forward-looking
statements.