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BETHESDA, Md., Hanger Orthopedic Group, Inc. (NYSE: HGR) has announced its wholly-owned
subsidiary Innovative Neurotronics, Inc. (IN, Inc.) received 510(k) clearance from
the U.S. Food and Drug Administration (FDA) to treat patients with the WalkAide
System®.
The first of IN, Inc.'s line of functional electrical stimulation products, the
WalkAide System is a medical device designed to counter the lack of ankle dorsiflexion,
commonly referred to as foot drop, in patients who have sustained damage to upper
motor neurons or pathways to the spinal cord. The WalkAide System electrically stimulates
the appropriate nerves and muscles. In addition to improving the patient's gait,
medical benefits of the WalkAide System may include increased mobility, prevention/retardation
of disuse atrophy, increased local blood flow, muscle re-education, and maintained
or increased joint range of motion.
"The commercial introduction of the WalkAide System will help us achieve our vision
of providing high technology products in the neuromuscular field by leveraging Hanger
s assets in distribution and patient care centers," Chairman of the Board and Chief
Executive Officer of Hanger Orthopedic Group, Inc. Ivan R. Sabel, CPO said.
Hanger also announced today IN, Inc.'s newly-appointed management team, led by President
Jeff Martin.
"IN, Inc. has taken a significant step forward in its evolution by receiving FDA
approval and creating a management team with the talent and depth of experience
to advance our mission and expand the field of Myo-Orthotics Technology®," Martin
said.
The IN, Inc. management team includes:
Conrad Kufta, MD - As Director of Clinical Development, Kufta is responsible for
the overall clinical strategy for IN, Inc.'s products, which encompasses clinical
trials and protocols. A board certified neurosurgeon and foremost specialist in
the surgical treatment of epilepsy, Kufta previously served as Senior Staff Neurosurgeon
and Medical Officer in the Surgical Neurology Branch of the National Institutes
of Health (NIH) in Bethesda, Maryland and Senior Staff Fellow in the Surgical Neurology
Branch of the National Institute of Neurological Disorders and Stroke (NINDS), a
clinical and research Institute within the NIH. A graduate of Georgetown University
School of Medicine, Kufta brings 35 years of medical experience to IN, Inc.
Joseph P. Moser - As Director of Product Development and Engineering, Moser is responsible
for development and engineering operations for all of IN, Inc.'s current and future
product lines, including oversight of design, validation, characterization, and
release to production. Having secured six U.S., four Canadian, and many International
patents, Moser has over 30 years engineering experience specializing in the design
and patenting of commercially viable medical and consumer products. A 1975 graduate
of the University of Michigan with a Bachelor of Science in electrical engineering,
Moser held numerous vice president and director level positions at companies such
as SnapShopper, Inc., Sabratek Corporation, and Information Resources, Inc.
Fayyaz Memon - As Director of Quality and Manufacturing, Memon is responsible for
the production of IN, Inc.'s products, including the establishment, implementation,
and maintenance of the quality system. Memon has 12 years direct experience developing,
implementing, and auditing regulatory compliance programs in FDA-regulated industries.
He has held leadership positions at Johnson & Johnson, SmithKline Beecham, Digene
Corporation, and MQS, Inc. Memon earned his Master of Business Administration in
Operations and Quality Management and his Master of Science in Mechanical (Manufacturing)
Engineering from Drexel University.
Pete Escallier - As Director of Marketing, Escallier is responsible for all marketing
programs and strategies. With a specialty in medical device marketing, Escallier
led the introduction of new products featuring proprietary technology and managed
existing products to higher levels of market share for companies such as MiniMed
/ Medtronic, Applied Medical, CompuMed, American Hydro-Surgical, and Edwards Life
Sciences. A graduate of the University of Southern California, Escallier has 28
years of marketing experience.
Carlo A. Luetto - As Director of Sales, Luetto provides strategic and operational
direction to the company's global sales operations. A medical sales director with
25 years experience selling medical devices and drug delivery systems, Luetto increased
share and profitability at American Medical Systems, MiniMed / Medtronic, and Caremark
/ Home Health Care, Inc. Luetto received his Bachelor of Science in Business Administration
from California State University, Long Beach.
Deanna Fish, CPO - A Certified Prosthetist/Orthotist (CPO), Fish is a Director of
Clinical Support. In this capacity, Fish establishes, implements, and maintains
clinical training, while supporting clinical trials. Fish has 20 years of O&P experience,
having held a number of leadership positions focused on patient care, clinical training
and development, marketing, operations, and product development. Fish earned her
Master of Science in Biomechanics from the University of Oregon in 1995 and her
Bachelor of Science in Prosthetics and Orthotics from the University of Washington
in 1985.
Mary-Kate Ennis, CO - As Director of Clinical Support, Ennis shares the responsibility
with Fish to establish, implement, and maintain all clinical training and support
clinical trials. A Certified Orthotist (CO), Ennis cared for patients at Children
s Healthcare of Atlanta and Connecticut Children's Medical Center. She received
her Master of Business Administration from Troy State University, her Bachelor of
Science in Physical and Health Education from Norwich University, and her orthotics
and prosthetics certificates from the Newington Certificate Program.
About Hanger Orthopedic Group, Inc.:
Hanger Orthopedic Group, Inc., headquartered in Bethesda, Maryland, is the world's
premier provider of orthotic and prosthetic patient care services. Hanger is the
market leader in the United States, owning and operating 618 patient care centers
in 45 states including the District of Columbia, with 3,405 employees including
1,017 practitioners. Hanger is organized into four units. The two key operating
units are patient care which consists of nationwide orthotic and prosthetic practice
centers and distribution which consists of distribution centers managing the supply
chain of orthotic and prosthetic componentry to Hanger and third party patient care
centers. The third is Linkia which is the first and only provider network management
company for the orthotics and prosthetics industry. The fourth unit, Innovative
Neurotronics, introduces emerging neuromuscular technologies developed through independent
research in a collaborative effort with industry suppliers worldwide. For more information
on Innovative Neurotronics, Inc, visit 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.
Investor Relations Contact(s): Jason Owen, 301-986-0701, jowen@hanger.com
Media Contact(s): Jennifer Bittner, 301-280-4869, jbittner@hanger.com
SOURCE Hanger Orthopedic Group, Inc.
CONTACT: Investor Relations: Jason Owen, +1-301-986-0701,
jowen@hanger.com; or Media: Jennifer Bittner, +1-301-280-4869,
jbittner@hanger.com, both of Hanger Orthopedic Group
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