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 such as Singapore. "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.
Yahoo News
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