Hanger Orthopedic Group Inc. has announced an agreement under which Hanger’s wholly-owned subsidiary Innovative Neurotronics Inc. has granted Teijin Pharma Limited exclusive rights to develop and commercialize Innovative Neurotronics’ initial product offering, the WalkAide System, in Japan. Teijin Pharma Limited is a wholly owned subsidiary of Teijin Limited, a multinational corporate enterprise headquartered in Osaka, Japan. The WalkAide System is a technology that employs functional electrical stimulation to combat lower limb neuromuscular paralysis.
“This agreement is a significant milestone in Innovative Neurotronics’ strategy to extend the adoption of its WalkAide System technology,” Innovative Neurotronics president Jeff Martin said in a company press release. “We are delighted that one of Japan’s leading health care companies will be working with us to make the WalkAide System available to the many thousands of people in Japan who can benefit from this advanced technological solution to neuromuscular impairment due to stroke, partial spinal cord injury and traumatic brain injury.”
“The consummation of this partnership is further validation of our technology and is a major step toward developing effective global distribution channels for our solution,” said Ivan Sabel, chairman and chief executive officer of Hanger Orthopedic Group Inc.
Under the terms of the agreement, Teijin Pharma Limited will be responsible for achieving regulatory approval to permit the WalkAide System to be marketed in Japan, and also will be responsible for attaining public reimbursement for the WalkAide System in Japan. Cleared by the U.S. Food and Drug Administration in September 2005 and made available in the United States in May 2006, the WalkAide System achieved ISO 13485:2003 and ISO 9001:2000 certification from BSI Inc. in October 2006, a requirement to obtain marketing approvals in Japan.
The WalkAide System employs functional electrical stimulation to treat foot drop due to stroke, spinal cord injury, traumatic brain injury and other pathologies such as multiple sclerosis and cerebral palsy.