02.11.2006 14:32:00
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Innovative Neurotronics Receives CE Mark Approval for the WalkAide System
BETHESDA, Md., Nov. 2 /PRNewswire/ -- Innovative Neurotronics, Inc. (IN, Inc.), a wholly-owned subsidiary of Hanger Orthopedic Group, Inc., announced today that it has received CE Mark approval for the WalkAide(R) System, a neuromuscular medical device that treats a condition of lower limb impairment known as foot drop. Achievement of the CE Mark indicates the WalkAide complies with EU regulatory requirements under the Medical Device Directive (MDD). This allows IN, Inc. to sell the WalkAide to the 25 nations in the European Union.
"Hundreds of thousands of people living with foot drop will now have access to technology that can allow them to regain their functionality and independence," President of IN, Inc. Jeff Martin said. "The CE Mark serves as one more validation of IN, Inc.'s commitment to delivering high quality neuromuscular devices worldwide."
IN, Inc. is currently in negotiations with a number of distributors who will make the WalkAide System available to medical professionals and patients in the European community. IN, Inc. earned ISO 13485:2003 and ISO 9001:2000 certifications for quality management in October.
Cleared for marketing by the FDA in September 2005 and officially launched in the United States on May 1, 2006, the WalkAide System treats patients with foot drop due to stroke, spinal cord injury, traumatic brain injury, and other pathologies such as multiple sclerosis and cerebral palsy.
About Innovative Neurotronics, Inc.: Specializing in the field of functional electrical stimulation, Innovative Neurotronics, Inc. identifies emerging Myo-Orthotics Technologies(TM) developed at research centers and universities throughout the world that use neuromuscular stimulation to improve the functionality of an impaired limb. The company's first product, the WalkAide(R) System, earned Frost & Sullivan's prestigious 2006 U.S. Orthopedics Product of the Year Award for being particularly innovative and superior to other offerings in this sector. Innovative Neurotronics, Inc. is a wholly owned subsidiary of Hanger Orthopedic Group, Inc. , the world's largest provider of orthotic and prosthetic (O&P) patient care. Headquartered in Bethesda, Maryland, Hanger owns and operates 619 patient care centers in 46 states including the District of Columbia, with 3,455 employees including 1,032 practitioners (as of 9/30/06). For more information on Innovative Neurotronics, Inc., visit http://www.ininc.us/. For more information on Hanger, visit http://www.hanger.com/.
Certain statements included in this press release are forward looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Please refer to the Company's SEC filings for factors that could cause actual results to differ materially from the Company's expectations.
CONTACT: Jennifer Bittner, +1-301-280-4869, jbittner@hanger.com, for Innovative Neurotronics, Inc.
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