Brainsgate’s technology is based on a miniature electrode implanted on the roof of the mouth within 24 hours following a stroke.

Stroke is the leading cause of adult long-term disability in the US. Out of the approximately five million stroke survivors living today in the US, 20% are disabled. The main problem in treating strokes has been the inability of effective drug delivery to the brain due to a mechanism called the “blood brain barrier,” which prevents large-molecule drugs from entering the central nervous system (CNS).

A procedure developed by an Israel company, Brainsgate solves this life-threatening problem by stimulating the CNS’ main nerve center – the spheno-palatine ganglion (SPG) – to increase blood flow to the brain. Called the Neuropath System, the technology is based on a miniature electrode implanted on the roof of the mouth within 24 hours following a stroke.

According to Brainsgate CEO Avinoam Dayan, the electrode emits signals to stimulate the SPG, which in turn widens the blood vessels to treat the symptoms of stroke.

“In less than 50 minutes, you can control the brain without being in the brain. We control the brain from the mouth,” Dayan told ISRAEL21c. He confesses that “it sounds crazy” – but it works.

The NeuroPath System impressed leading American technology magazine Red Herring and the Israel Venture Association enough for Brainsgate to receive a ‘Best Startup’ award in life sciences at the IVA’s recent annual conference in Tel Aviv. The judges wrote that NeuroPath “constitutes a breakthrough in treating diseases of the nervous system, brain cancer and stroke.”

“It was very nice to receive the award,” said Dayan. “It’s a small step of recognition, but in a way I prefer to be under the radar a little, not to be too much in the spotlight with a lot of expectations. I’m sure however, that the exposure will help the company grow.

“An idea like Brainsgate comes across very rarely. One the one hand, it’s totally innovative, and on the other hand, it’s so simple. That’s a winning formula. So I wasn’t too surprised when we were chosen.”

Those qualities were what drew Dayan, a former R&D executive with pharmaceutical giant J&J, to join the company last year, – five years after it was founded. He brought in some high profile investors like Boston Scientific and Elron Electronics Industries, which joined earlier backers Pitango Venture Capital, Alice Ventures and Infinity Ventures.

“The results of our animal trials point to nothing short of a major breakthrough in the field of stroke and other CNS diseases,” said Dr. Natan Bornstein, a member of Brainsgate’s scientific advisory board, chairman of Tel Aviv’s Sourasky Medical Center’s Neurology Department, where the trials took place.

Stroke occurs when part of the brain is deprived of adequate oxygen. There are two kinds of strokes: ischemic and hemorrhagic. Ischemic stroke occurs when the blood supply to the brain is interrupted, usually by a blood clot. The majority (85%) of strokes are ischemic.

During ischemic stroke, diminished blood supply initiates a series of events (called ischemic cascade) that results in damage to brain tissue and eventually death of brain tissue. Brain tissue death occurs in areas of no blood flow within minutes of stroke onset. Around such areas, there could be regions of reversible injured tissue, called the ischemic penumbra. The ischemic penumbra will finally die if no change in blood flow occurs, and hence saving the penumbra is the goal of acute stroke therapies.

“The concept is that when you have an ischemic stroke, the brain tissue needs to be regenerated and the blood flow needs to be increased to the places in the brain where it’s been slowed down -we’re talking about the tissue and the neurons which surround the core of the infarct,” explained Bornstein.

“By increasing the blood flow, we can also potentially enhance the brain plasticity in general – the capacity of the brain to recover from damage by creating new nerve centers and neurons,” he told ISRAEL21c.

“The results of our animal studies showed that there’s definitely an increase in the blood flow and also showed good results in terms of infarct volume and capacity of the animal to recover. Based on the data, we were so encouraged as to forge ahead for human trials.”

According to Dayan, the NeuroPath system was based on the research of Professor David Yarnitsky, the head of the neurological department at Rambam Hospital in Haifa.

“He discovered that the SPG dilates the vessels in the brain, but only later did he realized that if you dilate them enough that you can open up the BBB – the blood brain barrier,” he said.

The novel idea behind the NeuroPath was accessing the SPG through the mouth.

“There are tube canals on each side of the mouth, behind the last tooth. If you open it up less than a centimeter, you can insert the implant,” said Dayan.

“Any other procedure you can think of needs to open the brain in order to accomplish the same thing. When you tell medical professional this, the first reaction is ‘what do you mean?’ Are you nuts? Then they think about it more, and it beings to make sense – then they say ‘Wow.'”

Bornstein cautioned that the procedure must be implemented within the first 24 hours of the stroke taking place for it to be effective.
“If the window of time is too large, you reduce the chances and likelihood to save tissue,” he said.

While Brainsgate is currently focusing on the treatment of acute ischemic stroke, Dayan said that the technology can potentially deliver virtually any compound into the CNS, so it could conceivably be used to deliver drugs to treat diseases such as Alzheimer’s, Parkinson’s, and brain cancer.

Clinical trials have already begun in India, and are due to begin this summer in Germany, Hungary, Israel, and early next year in the US. Dayan expects the procedure to receive FDA approval in approximately three years.

“You insert the electrode, and repeat the procedure for three hours a day for seven to 14 days. The patient can even go home each day and come back,” said Bornstein.

“Yesterday (July 4th) was the first time we tested it on an actual stroke patient,” added Dayan. “We’ll always remember this Fourth of July – it was very exciting.”

(See Exclusive video report on BrainsGate from IsraelHighTech.TV).