|
Bethesda, MD — 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® 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™
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® 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. (NYSE:HGR), 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.
|