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Bioness Inc. Receives FDA Clearance and CE Mark for its NESS H200 Wireless System for Hand Paralysis as a Result of Stroke and Other Central Nervous System Disorders


10/4/2011 7:32:48 AM

VALENCIA, Calif., Oct. 4, 2011 /PRNewswire via COMTEX/ -- Bioness Inc. today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) and CE Mark Approval by the European Union for its NESS H200® Wireless Hand Rehabilitation System. This new wireless system allows patients to better integrate the NESS H200 into daily life, increasing therapy time which may lead to increased patient compliance and better outcomes.

The NESS H200 Wireless is an advanced hand rehabilitation system designed to use mild Functional Electrical Stimulation (FES) to improve hand function and promote motor recovery in patients who have lost function of their upper extremity following injury to the central nervous system such as stroke, traumatic brain injury or spinal cord injury. The device is intended to provide certain individuals with hand paralysis the ability to grasp and release objects while performing ordinary and essential activities of daily living.

"It is well known in rehabilitation that frequency of therapy and training has a direct impact on outcomes. Simply put, the more patients are able to be active and integrate therapy into their day to day lives, the better their outcomes," said Todd Cushman, Senior Vice-President of Global Business Development and Marketing for Bioness. "Our NESS H200 wireless device provides millions of stroke survivors that suffer hand paralysis a way to seamlessly and practically incorporate hand and arm activity into everyday life, allowing for increased therapy time with improved outcomes."

The device consists of three components: a wireless, lightweight and comfortable functional stimulation support (orthosis); a small handheld control unit that communicates wirelessly with the system; and a clinician's programmer that allows for easy programming and patient activity tracking. Designed for use in both the rehabilitation setting and the home, the NESS H200 Wireless may reduce muscle spasm, prevent muscle atrophy, reeducate muscles, increase local blood circulation and may improve hand activity or range of motion.

The company anticipates the NESS H200 Wireless will become commercially available to neurorehabilitation hospitals and centers in the U.S. and Europe, and to consumers for home use, later this year.

About Bioness Inc.

Bioness provides neuromodulation technologies that help improve lives and restore function for those living with neurological deficits and peripheral pain. The Company markets innovative neuromodulation products that help individuals with central nervous system disorders such as stroke, multiple sclerosis, spinal cord injury and traumatic brain injury regain movement in affected limbs. The NESS L300® Foot Drop System and NESS H200® Hand Rehabilitation System, and NESS L300® Plus System, cleared for use by the Food and Drug Administration, are designed to help patients achieve new levels of physical independence and productivity. Individual results vary. Consult with a qualified physician to find out if these products are right for you. Additional information about Bioness can be found at www.bioness.com .

NESS®, NESS L300®, NESS L300® Plus, NESS H200®, NESS H200® Wireless, Bioness® are trademarks of Bioness Inc | www.bioness.com | Rx Only

Media Contact:

Wendy Ryan/Courtney ConerySchwartz MSL781-684-0770bioness@schwartzmsl.com

SOURCE Bioness Inc.



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