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 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.