Exit Leaves Hole in Spinal Injury Market
by James Cavuoto, editor
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
months 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.
NeuroControls 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 firms 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 FreeHands 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. NeuroControls 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 devices
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 dont 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 NeuroControls 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.