The company's announcement follows a previous one in which it reported it received European CE Mark certification for its product. The company estimates the market for its product in the US to be worth in excess of $2 billion, and said it expects a substantial increase in sales following the FDA approval and the launch of marketing in the US.
CEO Shmuel Shany stated that the product was designed for use by rehabilitation centers and private patients. "In the US, there are 2,000-3,000 rehabilitation centers and these centers can buy the devices and supply them to patients. The equipment can also be used by private patients in their own homes." The company intends to sell the L300 at $6,000 per unit, and is in talks with medical insurance providers to finance the purchase for private users who can't afford to buy it themselves.
NESS's main investor is Teuza - Venture Ltd. (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 and others. The company will distribute the product in the US through Bioness, a joint NESS-Alfred Mann subsidiary.
NESS's core technology is based on the use of computerized "functional electrical stimulation" (FES). This can be used to activate paralyzed muscles and to restore partial movement. FES works by creating electrical pulses that are carried by small nerve fibers to the muscles, and cause the muscles to contract and release. This helps to relieve the effects of paralysis and facilitates the development of pathways for voluntary control
After 13 years of research and development that cost $25m. NESS, an acronym for Neuromuscular Electrical Stimulation Systems (NESS) Ltd. is well on its way to commercialize its flagship product "The Handmaster".
The Handmaster, is a non-invasive system for paralyzed hands. It incorporates and integrates advanced upper limb rehabilitation technologies in a single system for patients' independent use. FES or Functional Electrical Stimulation is a rehabilitation technology using electric current impulses applied to the neuromuscular system that activate the muscles and negotiate movement, increases local blood flow while lessening spasticity.
It is the first in a line of a planned range of products whose aim is to provide comprehensive treatment of the paralyzed hand and eventually other parts of the body.
The Handmaster consists of a size-adjustable splint that incorporates an integral electrode system and is connected by a cable to a small and user-friendly electronic control unit. The splint is easily applied and removed by the user and is designed for independent use at home.
The underlying technology was developed by Professor Roger Nathan of Ben-Gurion University who continues to guide the research and development program of the company.
Medical device company NESS Neuromuscular Electrical Stimulation Systems Ltd. announced that it received US Food and Drug Administration (FDA) approval to market its NESS L300 device for moving paralyzed legs.