QUEBEC CITY, Feb. 3 /PRNewswire-FirstCall/ - Victhom Human Bionics Inc., "Victhom" , 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 lifestyle.
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 expedient manner.
"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 statements.
CONTACT: Nader Kameli, Chief Operating Officer, Neurobionix division,
Victhom Human Bionics Inc., (418) 872-5665, Fax: (418) 872-6926,
email@example.com; www.victhom.com; Source: Victhom Human Bionics