Tel Aviv – 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.
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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.
With only six patients receiving the treatment, even the weakest statistics are unreliable. This needs to be tested with a MUCH larger group to make any claims of effectiveness.
Of course this a small study, that is the way new medicines and treatments have to do it to get FDA approval. First a very small Phase 1 study to see if there is any effect, than a larger Phase 2 study to see if there are any side effects, than the real testing begins with 100s of people participating in tests to see percentage of successes and frequency of side effects. And even with these three sets of tests, there are still occasional mistakes such as drugs which have long-term negative consequences which are not manifest until later.
Alzheimers is such a horrible way to lose a loved one, who is often still physically present and sometimes aware of their own loss of capacity, and so draining on the family and caregiver, that any real grounds for hope is good news. Halevai this should bring some help to the many people who need it….
The system is greatly overpriced because they have the exclusive but only until other people figure out what makes it work and more competition will bring prices down.
There are many more people suffering from ADD and ADHD than from Alzheimer’s and anything which is non invasive and WORKS for cognitive enhancement on Alzheimer’s is sure to work on ADD and ADHD, too.
Since the devise is non-invasive and has zero risk involved (not unlike playing a computer game) there is no real valid reason why it should be marketed as a medical device and why we need to wait years for FDA approval.
The only silly reason why this computer game is marketed as medical device is because only this way can they get US medical insurance to pay for it and only this wy can they take a chair and computer game which should costs less than $1,000 each and charge hospitals a minimum of $500,000 each, because they have the patent on the $1,000 chair.
There are system out there that do exceptional cognitive enhancement via computer games and Neuro-Feedback systems that costs only about $2,000 each and they work 100% for ADD and ADHD and (for Alzheimer’s, unofficially), called Play_Attention.