Israel-based Neuronix, which has developed a non-invasive medical device
to help to treat Alzheimer's disease, expects the system to be approved by the
U.S. Food & Drug Administration in late 2014.
The device, which combines electromagnetic stimulation with
computer-based cognitive training, is already approved for use in Europe,
Israel and several Asian countries. In Singapore it is approved for clinical
trial use and the application for registration of the product is still under
evaluation. "You stimulate the brain on a biological level as well as on a
cognitive level," Neuronix CEO Eyal Baror told Reuters, saying this double
approach created longer-lasting benefits.
The device, which consists of a chair containing an electronic system
and software in the back and a coil placed at the head, has been tested on mild
to moderate Alzheimer's patients who suffer from dementia but are not totally
dependent. The system is in trials at Harvard Medical School/Beth Israel
Deaconess Medical Centre. Patients are treated for one hour a day, five days a
week over six weeks. "We see improvement lasting for 9-12 months and the
good thing is that patients can return and undergo treatment again," Baror
said. "If out of 10 years the patients have left to live we can keep them
at home in a relatively mild state of the disease for three, four, five years,
it's a lot."
According to Alvaro Pascual-Leone, director of the hospital's
Berenson-Allen Centre for Non-invasive Brain Stimulation, brain stimulation -
or transcranial magnetic stimulation - involves a very low current applied to a
specific part of the brain and is approved by the FDA for treatment of a
variety of ailments and diagnostic applications. "The application in Alzheimer's
disease and in combination with cognitive training is novel,"
Pascual-Leono said in a phone interview from Boston. About 20 percent of
patients experience a mild headache but there are no long-term negative
effects, he said.
Pascual-Leone, who is principal investigator in the Harvard trial, said
that of 12 patients in the study, six received the real treatment and all
showed cognitive improvement. Their improvement was significantly more than the
average seen in patients taking just medication, he said. The study's results
will be submitted for publication in the coming weeks and a follow-up study on
30 patients is planned.
Neuronix received European approval several months ago and has
installations in the UK and Germany. In Israel, a few dozen patients are being
treated with the device. The U.S. trials are expected to run till the end of
2013. Neuronix is also running a trial in Israel for pre-Alzheimer's patients. The
company expects to sell half a dozen systems in the second half of 2012 and three
dozen in 2013. In Israel, the treatment costs $6,000. "Our target for
becoming profitable is in parallel to entering the U.S. market around
2015," Baror said.
Neuronix has raised $8 million from private individuals as well as in
grants from the Israeli Chief Scientist's Office and is exploring options to
raise more money in the coming year, including the possibility of going public.
(This version of the October 24 story corrects paragraph two that company
corrects to say that in Singapore, device is approved for clinical trial use
and its application for registration of the product is under evaluation, not
that device is approved for commercial use.)
Source: Chicago Tribune
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