FDA Clears NESS Handmaster for US Market

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NESS: New Hope for Millions of Stroke Victims


WASHINGTON--(BW HealthWire)--Nov. 26, 2001--

FDA Clears NESS Handmaster for US Market

NESS (Neuromuscular Electrical Stimulation Systems Ltd) today announced the Food and Drug Administration's (FDA) 510(k) clearance of their noninvasive, neuro-prosthetic device, the Handmaster.

This medical device helps activate the impaired or paralyzed hand of a person who has suffered a stroke.

NESS (www.nessltd.com) Handmaster represents a significant and long-awaited technological advance, bringing new hope for a more independent lifestyle to over 1 million disabled stroke survivors in the U.S. alone. Inside the Handmaster is NESS' patented, integrated surface electrode design. Low-level electronic pulses stimulate the neuromuscular system and activate the muscles of the hand and forearm to restore natural flowing patterns of movement to the hand.

"As a result of many years of research and development, we have been successful in developing the technology to restore to persons who have suffered a debilitating stroke the functional use of their plegic or paralyzed hand. I am thrilled each time I see one of our Handmaster users overcome their disabilities and achieve more and more in life," stated Roger Nathan Ph.D, NESS vice president of research and development and board member of the International Society of Functional Electrical Stimulation Systems (ISFES).

The Handmaster is designed for simple home usage. An intensive study was conducted at the University of Maryland-Baltimore to document, statistically and clinically, the functional benefits to individuals that have residual paralysis of the hand following stroke. "The Handmaster showed impressive results with our study group. Within three weeks, all were able to grasp, hold and release objects while using the device and perform tasks they were previously unable to do," stated Dr. Gad Alon, Principle Investigator, University of Maryland School of Medicine. Among activities regained included: The ability to pour and drink from a glass, food preparation, and the return to pleasurable hobbies like gardening and woodworking. NESS has engaged the consulting services of The Lewin Group, a unit of Quintiles Transnational Corp., to facilitate Medicare reimbursement procedures.

"The Handmaster is presently marketed in Israel and Holland. We expect to have the product available in the US by the second quarter of 2002. In addition to obtaining clearance for the Handmaster for the stroke population, we are also studying the return of hand function in the traumatic brain injury group to go along with this clearance and a previous one in the spinal cord injured population," added Shmulik Shany, NESS CEO.

NESS maintains international headquarters in Ra'anana, Israel, just north of Tel Aviv. Founded in 1991, NESS is a company devoted to creating new and innovative medical devices.

Note: Pictures of the Handmaster are located at www.nessltd.com

CONTACT:

NESS (Neuromuscular Electrical Stimulation Systems Ltd)

Dan Doyle, 908/638-5347

E-mail: dandoyle@blast.net