QUEBEC CITY, April 16 /PRNewswire-FirstCall/ - Victhom Human Bionics Inc. (Victhom, TSX: VHB) today disclosed initial results from the ongoing human clinical trial of its Closed-Loop neuromodulation System (CLS) used in the Neurostep(TM) for the treatment of patients suffering from foot drop secondary to a central nervous system lesion. According to the Company, the initial results of the trial have demonstrated that the Neurostep(TM) is capable of collecting sensory signals from a nerve and of stimulating the appropriate muscle groups, which represents, to the knowledge of the Company, the world's first proof of concept in a human clinical trial of a CLS product used on peripheral nerves.
The ongoing human clinical trial on the Neurostep(TM) has two major objectives. The first objective is to evaluate the sensing and stimulation mechanisms of the product. The initial results suggest that the Neurostep(TM) is capable of collecting sensory signals from a nerve located in the thigh. The interim results also demonstrate the capacity of the Neurostep(TM), based on the information collected from the nerve, to stimulate the appropriate muscle group to lift the foot in the desired direction and in synchronization with the patient's gait.
The Company expects to announce later this year results on the second major objective of the trial aimed at evaluating the efficacy of the Neurostep (TM) in providing clinically measurable benefits, such as helping patients to walk faster and over longer distances.
Mr. Nader Kameli, Chief Operating Officer of the Neurobionix division, said: "We are excited about the initial results coming out of the clinical trial, which further increase our confidence in the ability of the closed-loop technology to open the door to next generation products in the neuromodulation industry that can deliver therapy to patients in a more effective manner than the continuous or pre-programmed stimulation regimen delivered by current generation devices". Mr. Kameli also stated: "With these promising initial results on the CLS platform proof of concept in humans, Victhom is well positioned to leverage its unique technology for the development of new exciting indications".
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.
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.
|SOURCE VICTHOM HUMAN BIONICS INC.|
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