Not quite sure what is being trialled!
Victhom Human Bionics announces the start of patient enrolment for its Neurostep(TM) clinical trial
Victhom Human Bionics Inc. announces today that it received approval from the Ethics Review Board of the rehabilitation center where its clinical trial on gait disorders will be held. The Company received its Investigational Testing Authorization in December 2006 from Health Canada. The Neurostep(TM) is designed to treat, through neuromodulation, gait disorders (e.g., foot drop) secondary to a lesion of the central nervous system caused by conditions such as stroke or multiple sclerosis. Over one million patients in the U.S. and in Europe could benefit from this product.
Dr. Guy Chamberland, M.Sc., Ph.D., Vice President Clinical and Regulatory Affairs, stated that the Company was initiating patient enrolment for its clinical trial this month. This will be the world's first human trial of a fully implantable Closed-Loop System (sensing and stimulation) for the peripheral nervous system.
Mr. Stéphane Bédard, Executive Vice President and COO, stated that in light of the above, the Company is focusing the R&D activities of its NeuroBionix division on the clinical development of the Neurostep(TM) and aggressively pursuing the development of a closed-loop neuromodulator (neurosensing and neurostimulation of the peripheral nervous system) for the treatment of pathologies such as sleep apnea, obesity and chronic pain. Victhom also announced it has put on hold the preclinical development of a bladder neuroprosthesis for patients with spinal cord injury. This decision was made after a normal course review of the entire portfolio of programs under development and to optimise R&D expenses.
Source: VICTHOM HUMAN BIONICS INC.