NESS gets CE Mark certification for foot paralysis device

The company will initially market the NESS L300 in Israel and the Netherlands. The European market is estimated at $1.8 billion.

After a lengthy launch preparation period, medical devices company NESS - Neuromuscular Electrical Stimulation Systems Ltd. has launched its NESS L300 device for moving paralyzed feet. The company has obtained European CE Mark certification for the device, and will market it in Israel and the Netherlands. The company estimates the market for its device at $1.8 billion in Europe alone. The company also expects to shortly announce US Food and Drug Administration (FDA) certification for marketing the device in the US.

NESS has already developed and markets the NESS H200 for supporting movement in paralyzed hands. The device is attached to the patient’s wrist, and electrodes stimulate nerves, enabling the patient to move the limb. Research by the company found that the nerve stimulation slightly improves the paralysis, enabling limited movement even when the patient does not wear the device.

NESS’s largest investor is (TASE:TUZA), with a 34% stake. Other investors are businessman Alfred Mann, BG Technologies and Applications (the technology transfer company of Ben Gurion University of the Negev), Johnson and Johnson Development Corporation, ABN Amro Capital, Dow Corporate Venture Capital, Life Sciences Partner, and Israel-United States Binational Industrial Research and Development Foundation (BIRD-F).

The NESS L300 was developed over the past two years on the basis of functional electrical stimulation (FES) medical technology used to develop the NESS H200. The NESS L300 is targeted to 25% of people with brain injuries who suffer from drop foot, which prevents normal walking without the use of a cane or walker.

The NESS L300 comprises a sensor placed in the foot, which sends a wireless signal to a computer system placed under the knee. The system sends an electrical stimulation signal that replaces the non-functioning nerve signal from the brain, and tells the paralyzed foot to take the next step.

NESS estimates potential sales for the NESS L300 at thousands of devices a year within the next two years. NESS CEO Shmuel Shany says, “Analysts estimate the potential market for the device at hundreds of thousands of units a year in the West, and 180,000 units a year in NESS’s currents market in the US, Israel and the Netherlands.”

NESS will sell the NESS L300 simultaneously in Israel and Europe. NESS Holland, a wholly owned subsidiary, will handle sales in Europe. After FDA approval is obtained, sales in the US will be handled by a joint NESS-Alfred Mann subsidiary.

Published by Globes [online], Israel business news - www.globes.co.il - on June 29, 2006

© Copyright of Globes Publisher Itonut (1983) Ltd. 2006

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