SOURCE: Restorative Therapies, Inc.

August 23, 2005 15:21 ET

Restorative Therapies, Inc., Receives FDA Clearance for RT300-S

Restorative Therapies, Inc., Founded by John McDonald, MD, PhD, Lead Neurologist to the Late Christopher Reeve, Launches a New Era in Treatment for Neurological Injury and Paralysis

BALTIMORE, MD -- (MARKET WIRE) -- August 23, 2005 -- Restorative Therapies, Inc., a designer and supplier of medical devices, today announces FDA clearance of its breakthrough medical device, the RT300-S, a functional electrical stimulation (FES) motorized cycle ergometer.

In the treatment of neurological damage, FES is used to restore motor functions to previously paralyzed muscles. The RT300-S delivers electrical currents to activate the quadriceps, hamstring and gluteal muscles, enabling the legs to move through a regular patterned physical activity.

"Our clinical studies show that people who are paralyzed can actually regain function through regular patterned physical activity such as cycling using the RT300-S," says John McDonald, MD, PhD, founder of Restorative Therapies, Inc., and director of the International Center for Spinal Cord Injury at the Kennedy Krieger Institute in Baltimore. "Studies reveal that such activity improves patients' quality of life by promoting overall physical integrity: improving cardiovascular health; preventing skin breakdown; reducing the incidence of osteoporosis and other secondary complications resulting from prolonged immobility. As an important activity in the lives of those with neurological impairment, this is a therapy that individuals, especially children whose nervous systems are still developing, can do now to promote their general health and physical well-being," McDonald concludes.

Restorative Therapies' pediatric model, the RT300-SP, designed for children aged 4-to-12 years, is also available for clinical use in the United States.

"Until now, children with spinal cord injuries have not had the opportunity to cycle with FES," says Therese E. Johnston, MSPT, Research Specialist at the Shriners Hospital for Children, Phila., Pa. "This device provides unique opportunities for children as they are still growing and changing, potentially allowing for even greater benefits. It is inspiring to see children use the RT300-SP for the first time as many do not remember having movement in their legs, and are finding great excitement in seeing their legs move the pedals of the ergometer," says Johnston.

Besides its clinical efficacy, the RT300-S also breaks the usability barrier by setting new standards for both the clinic and home use, via its portable, small size; easy drive-up usage straight from the wheelchair; automated therapy, where in many cases, an individual can use the RT300-S independently; and integrated electrical stimulation and motor systems. "By using Pocket PC, BlueTooth and Windows Mobile technologies, the RT300-S sets a new technological benchmark in the field of rehabilitation," says Andrew Barriskill, CEO of Restorative Therapies.

About Restorative Therapies, Inc.

Restorative Therapies (www.restorative-therapies.com), is a privately held company headquartered in Baltimore, Md., whose mission is to help people with neurological impairment achieve their full recovery potential. As one of the first companies to target activity-based therapy and FES as a potential treatment for stroke, spinal cord injury, and other neurological diseases and disorders, Restorative Therapies was awarded the "Most Promising Start-Up" in 2005 by Neurotech Business Report, a leading publication targeting the neurotechnology industry. Restorative Therapies plans to release the RT300-S for clinical use in Europe, Canada, and Australia in late 2005.

About Dr. John McDonald

John W. McDonald, MD, PhD, directs the International Center for Spinal Cord Injury at Kennedy Krieger Institute. From 1998-2004, prior to joining Kennedy Krieger, he founded and served as director of the Spinal Cord Injury Program at Washington University School of Medicine in St. Louis. His work has been recognized by many organizations, including the National Institutes of Health, International Neurotrauma Society and American Academy of Neurology.

Dr. McDonald also leads multi-center clinical trials in spinal cord injury repair. He has completed six trials to date, including the first human stem cell transplantation study and an investigation into the effectiveness of restorative therapy in 60 adults with spinal cord injuries. Dr. McDonald and his team at Kennedy Krieger will soon join a prospective, multi-center trial evaluating the efficacy of restorative therapies in children.

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