The market for functional electrical stimulation and neural prostheses was dealt a shock recently when NeuroControl Corp. announced that it would no longer market products targeted at persons with spinal cord injury, and will instead concentrate on products for treating stroke. The decision, which came in the wake of significant staff reductions at the Valley View, OH firm last fall, means that NeuroControl will no longer promote its FreeHand implanted hand-grasp stimulator or its VoCare bladder control prosthesis to new customers, though it will continue to service existing customers. A NeuroControl executive said the firm is looking for another organization to take over the product line.
The move sent reverberations through the research community in functional electrical stimulation field, prompting spirited discussions as last month's meeting of the American Spinal Injury Association in Vancouver, B.C. There, researchers from the Cleveland FES Center and Case Western Reserve University, where the FreeHand system was originally developed, pushed the case for developing neural prostheses for the spinal cord injury community, despite the NeuroControl decision. The Cleveland researchers demonstrated progress on a lower-extremity motor prosthesis that enables paraplegics to stand up.
NeuroControl's exit from the SCI market has created an opportunity for Australia-based Neopraxis, Ltd., which remains one of the few firms targeting this population. The company, a spinoff of Cochlear Ltd., is using a modified version of that firm's Nucleus 22-channel auditory stimulator to control a lower extremity motor prosthesis. The Praxis FES24 system consists of a body-worn controller, a transmitting coil, the implanted 22-channel stimulator, and surgically implanted electrodes in the legs, hip regions, gluteal muscles, and sacrum. External sensor packs, each containing a gyroscope and two accelerometers, are attached to the thigh, shank, and trunk to provide real-time feedback on body position. The system is currently undergoing investigational trials in the U.S. It is intended for otherwise healthy persons with spinal cord injury at the thoracic level. Patients generally train for the device using a surface stimulator for several weeks prior to surgical implantation.
There is also a significant development effort for a walking prosthesis underway in Europe. The Stand Up and Walk demonstration project is funded in part by the European Commission, which provided 1.5 million euros, and a network of European corporations and research institutions, including IBM France, Thomson CSF, MXM Laboratories, Neuromedics, the Fraunhofer Institute in Germany, Roessingh Research and Development in the Netherlands, and the University of Montpellier in France, which together put up another 1.5 million euros.
One of the first companies to market a product for the spinal cord injury market was a firm called Sigmedics. In 1994, they received FDA approval for a device called Parastep, which included a four-channel stimulator and surface electrodes applied to the legs of paraplegics. The user controlled the stimulator using buttons located on the handles of a walker. The device cost about $20,000, which some observers felt was excessive given the relatively simple electronics and surface stimulation. Sigmedics burned through its venture capital and closed its doors before selling more than a handful of the devices.
The Israeli company NESS had also targeted the quadriplegic market with its HandMaster stimulator, which received FDA approval in 2001. But that product, which consists of a forearm orthosis with surface electrodes, now appears to be doing better in the stroke market, in part because of the difficulty quadriplegics have in donning and doffing the device.
Observers of the neural prostheses market point out several reasons for FreeHand's lack of commercial success. Perhaps the biggest problem is the size of the potential market. There are roughly 10,000 new cases of spinal cord injury in the U.S. each year. Of these, only a small minority are at the C5/C6 level of tetraplegia, at whom FreeHand is targeted. NeuroControl's investors, which include InvaCare, Primus Ventures, and Morganthaler Ventures, liked the numbers better from the stroke market (see article below).
Although FreeHand users, of which there are about 200, and the orthopedic surgeons who implant them, are generally pleased with the device's performance, the clinician community responsible for spinal cord injury patients, physical medicine and rehabilitation specialists, or physiatrists, have been slow to recommend the product to their C5/C6 patients. In part this stems from their inherent distrust of implanted devices-some physiatrists fear their patients will be used as guinea pigs. More cynical observers suspect that physiatrists don't refer their patients to orthopedic surgeons for reasons that have more to do with control of a revenue stream.
In any case, most acknowledge that NeuroControl could have done a better job of promoting the product to physiatrists in the early stages of clinical trials even though those trials involved neurologists and orthopedic surgeons more than physical medicine.
The outlook for NeuroControl's VoCare system may be more rosy than for FreeHand. That product had been sold in Europe under the Finetech-Brindley name before NeuroControl picked up marketing rights and Finetech Medical, the U.K. firm that makes the product, plans to continue selling it. Of the 2,000 SCI patients implanted with the bladder system, only 80 were sold by NeuroControl in the U.S.; the remainder were sold in Europe. And since loss of bladder function affects nearly all people with spinal cord injury, regardless of the location of the spinal lesion, the market potential is more pronounced than tetraplegia alone.
While it remains to be seen how much commercial potential remains in the spinal cord injury market, the outlook, absent a well funded and collaborative effort to build devices for a wide range of neurological diseases and disorders, seems less than promising at the moment.
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