FDA Clears Unilateral Stimulation for the RT300 Functional Electrical Stimulation (FES) Motorized Cycle Ergometer

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Restorative Therapies, Inc., today announced FDA clearance of Unilateral Stimulation for its successful medical device, the RT300, a Functional electrical stimulation (FES) motorized cycle ergometer. Unilateral Stimulation allows clinicians to provide the RT300 activity based therapy to a wider range of patients who were previously unable to benefit from FES cycling therapy as a part of their rehabilitation.

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Restorative Therapies, Inc., advances its New Era in Treatment for Neurological Injury and Paralysis.

Restorative Therapies, Inc., a designer of medical devices, today announced FDA clearance of Unilateral Stimulation for its successful medical device, the RT300, a functional electrical stimulation (FES) motorized cycle ergometer.

In the treatment of neurological damage, FES is used to evoke physical activity and exercise not otherwise possible for individuals with neurological impairment. The RT300 delivers electrical currents to activate leg muscles important for walking including the quadriceps, hamstring and gluteal muscles, enabling paralyzed legs to move through a regular patterned physical activity.

The new Unilateral Stimulation feature also stimulates the muscle groups in the lower leg which raise and lower the foot during walking.

"Often after a stroke, only one side of the body is impaired," says John McDonald, MD, PhD, founder of Restorative Therapies, Inc., lead Neurologist to the Late Christopher Reeve, and director of the International Center for Spinal Cord Injury at the Kennedy Krieger Institute in Baltimore. "This new Unilateral Stimulation feature allows clinicians to provide the RT300 activity based therapy to a much wider range of patients who were previously unable to benefit from FES cycling therapy as a part of their rehabilitation." McDonald concludes.

"Unilateral stimulation expands the number of muscle groups that we electrically stimulate so that the whole lower extremity becomes involved," says Andrew Barriskill, CEO of Restorative Therapies. "We are now starting a study with Dr Gad Alon at the University of Maryland, School of Medicine, to further investigate the benefits of this new therapy for chronic stroke patients."

Unilateral Stimulation is the latest result of Restorative Therapies commitment to ongoing development of the RT300 system. This includes a pending FDA 510(k) submission expanding the RT300 to also provide electrical stimulation for the arms.

About Restorative Therapies, Inc.
Restorative Therapies (http://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. Restorative Therapies is one of the first companies to target activity-based therapy and FES as a treatment for immobility associated with paralysis such as stroke, multiple sclerosis and spinal cord injury. For further information please call 800 609-9166.

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 clinical and scientific work has been recognized by many organizations, including the National Institutes of Health, International Neurotrauma Society and American Academy of Neurology.

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