QUEBEC CITY, Feb. 3 /CNW Telbec/ - Victhom Human Bionics Inc., "Victhom"
(TSX:VHB), announced today that its Neurobionix division has obtained CE Mark
approval for its Neurostep(TM) System, the first ever approval for a
closed-loop system (CLS) used on peripheral nerves. CE Mark represents
regulatory approval needed for the sale of the Neurostep(TM) in any of the
Member States of the European Union.
The Neurostep(TM), a fully implantable investigational neuromodulation
product designed to treat gait disorders (e.g., foot drop), is the first CLS
product aimed at using the patient's own nervous system as the source for
detection of intention to move and control their leg. Contrary to other
systems that use surrogates such as external sensors, the Neurostep(TM)
detects intrinsic muscle activities and surface sensation events from the
nerve signals delivered to the spine and brain. This information is then used
as the trigger for intervention through neurostimulation, as needed, to
complete function. We believe that patients implanted with the Neurostep(TM)
will experience remedy to their foot drop and an improved walking pattern that
should contribute to give them more independent mobility and a healthier
CE Mark approval gives the Neurobionix division the ability to train and
educate physicians in preparation for market release of the Neurostep(TM)
System, which is planned for late 2009 in the European Union. The clearance to
enter the European market allows the Neurobionix division to increase its
market development activity by identification and education of hospitals and
physicians that would introduce this new solution to patients in the most
"The approval of the Neurostep(TM) System marks a major milestone in the
repositioning of the Neurobionix division into a full function organization
that can develop and deliver products of a distinctive value for the market",
said Mr. Nader Kameli, Chief Operating Officer of the Neurobionix division. He
further said, "We feel confident that we can build on this success to enable
commercial launch of the Neurostep(TM) System in the European market in 2009".
While the Neurostep(TM) System is not currently available in the United
States, Victhom is planning to engage with the U.S. Food and Drug
Administration (FDA) to pursue plans for bringing this new solution for foot
drop therapy to patients in the United States.
"Accomplishing CE Mark approval is the latest step in what continues to
be the steady advance toward commercialization of the Neurostep(TM)", said Mr.
Normand Rivard, Acting President of the Company. "These recent accomplishments
are an indication of our commitment to this business and the ability of the
Company to deliver on its scientific and business objectives", he added.
Victhom discovers, develops and manufactures bionic devices involved in
the treatment of a variety of physical and physiological dysfunctions.
Victhom's Neurobionix division 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 division develops biomechatronic
products to support or replace peripheral limbs in what is known as the
orthotics and prosthetics market.
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
For further information:
For further information: Nader Kameli, Chief Operating Officer,
Neurobionix division, Victhom Human Bionics Inc., (418) 872-5665, Fax: (418)
872-6926, firstname.lastname@example.org; www.victhom.com; Source: Victhom Human