QUEBEC, Canada, Nov. 22 /PRNewswire-FirstCall/ - Victhom Human Bionics Inc. announces today that it met last week with the Center for Devices and Radiological Health (CDRH), United States (US) Food and Drug Administration (FDA) to discuss the clinical development of its Neurostep(TM), a closed-loop peripheral nerve-sensing and nerve-stimulating medical device. 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.
The Company had requested this pre-Investigational Device Exemption (IDE) meeting with the FDA to discuss the clinical development of the Neurostep(TM). Dr. Guy Chamberland, Victhom’s Vice President for Clinical and Regulatory Affairs, commented that the meeting with FDA was very constructive. He also stated that the data that will be collected from the first Canadian trial, along with the guidance provided by CDRH would allow the Company to finalize the design of a clinical protocol for a pivotal trial.
Victhom Human Bionics plans to initiate its first clinical trial of the Neurostep(TM) in Canada before the end of this year and plans to meet with its Clinical Advisory Board in 2007 to discuss the design of a pivotal clinical trial. This latter trial would be designed to support a Pre-Market Approval (PMA) application in the US.
About Victhom
Victhom Human Bionics researches, develops and delivers bionic devices that treat a variety of physiological dysfunctions. The Company has nearly 90 employees and two research units: BioTronix and NeuroBionix.
Victhom manages a portfolio of 37 granted and 85 pending patents filed in various countries and 13 registered trademarks worldwide. The Company has established an ongoing process to ensure the protection of its intellectual property and to pursue new filings.
(x) Forward-looking statements contained in this press release involve known and unknown risks, uncertainties or other factors that may cause actual results, performance or achievements of the Company to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements.
Website: www.victhom.com Source: Victhom Human Bionics Inc. For more information: Victhom Human Bionics Mr. Benoit Huet President and CEO Tel.: (418) 872-5665, ext. 103 Fax: (418) 872-6926 benoit.huet@victhom.com Media Relations Frederic Tremblay HKDP Communications and Public Affairs Tel.: (514) 395-0375, ext. 234 ftremblay@hkdp.qc.ca
VICTHOM HUMAN BIONICS INC.
CONTACT: Victhom Human Bionics: Mr. Benoit Huet, President and CEO, (418)872-5665, ext. 103, Fax: (418) 872-6926, benoit.huet@victhom.com; MediaRelations: Frederic Tremblay, HKDP Communications and Public Affairs, (514)395-0375, ext. 234, ftremblay@hkdp.qc.ca; www.victhom.com; Source: VicthomHuman Bionics Inc.
