Healthcare Industry News: Digene
News Release - February 2, 2006
Hanger Orthopedic Group Gains FDA Approval, Announces New Management Team of Subsidiary Innovative NeurotronicsBETHESDA, Md., Feb. 2 (HSMN NewsFeed) -- 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 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.
Source: Hanger Orthopedic Group
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