VHB meet Health Canada
Victhom meets with Health Canada for CLS testing
2006-07-19 12:03 ET - News Release
Mr. Benoit Huet reports
VICTHOM HUMAN BIONICS ANNOUNCES A PRE-ITA MEETING WITH HEALTH CANADA FOR NEUROSTEP(TM) SYSTEM
Victhom Human Bionics Inc. is confirming that it met last week with the medical devices bureau of Health Canada to discuss the clinical development of its Neurostep medical device, a closed loop functional electrical stimulating device (CLS) designed to treat gait disorders secondary to a lesion of the central nervous system such as foot drop.
Foot drop is a frequent result of neurological disorders such as stroke. It is a condition in which the foot hangs paralyzed in a plantar-flexed position. Foot drop is also common in other neurological conditions such as multiple sclerosis, incomplete spinal cord injury, cerebral palsy, traumatic brain injury or postpolio.
As part of its global regulatory strategy for the Neurostep medical device, the company requested a preinvestigational testing authorization (ITA) meeting with Health Canada to discuss its clinical development program for testing involving human subjects. This is the first phase in the clinical development of the Neurostep. Dr. G. Chamberland, PhD, Victhom's vice-president clinical and regulatory affairs, commented that meeting with Health Canada does not suggest that Health Canada will not object to the conduct of a clinical trial but that these pre-ITA meetings are a forum for companies to discuss various aspects of the development of a product and obtain guidance from the regulatory authorities.
Victhom Human Bionics is on schedule for the development of the Neurostep medical device and plans to submit later this year an application for an investigational testing authorization to the medical device bureau, therapeutic products directorate in Canada later this year. This medical device is the world's first CLS designed to treat gait disorders. Neurotechnology represents a market worth more than $3-billion worldwide.
We seek Safe Harbor.